Etravirine Effective At HIV Supression: Duet Trials 1 And 2

Treatment with TMC125 (etravirine) leads to better virological suppression than placebo
as part of antiretroviral therapy in patients with documented resistance to non-nucleoside
reverse transcriptase inhibitors (NNRTIs), conclude two randomised trials in this week's issue
of The Lancet.



TMC125 is a well tolerated new NNRTI with activity against both wild-type and NNRTI-
resistant HIV-1. It is hoped that TMC125 will be part of the next generation of antiretrovirals
with activity against resistant virus and a high genetic barrier to the development of
resistance, which will help address a major unmet clinical need.



The DUET-1 and DUET-2 randomised, phase III studies examine the efficacy, safety, and
tolerability of TMC125 compared with placebo in treatment-experienced patients with
NNRTI-resistant HIV-1 infection. After 24 weeks, a higher proportion of patients who
received TMC125 achieved a viral load of less than 50 copies per mL than did those in the
placebo group (56% vs 39% in DUET-1 and 62% vs 44% in DUET-2). Furthermore, the safety
and tolerability profile of TMC125 was generally comparable with placebo.



The authors of DUET-2, Adriano Lazzarin (San Raffaele University, Milan, Italy) and colleagues
point out that: "The magnitude of the results seen with TMC125??¦and the similarity of the
responses across both trials done in different countries, indicate the higher genetic barrier to
resistance of TMC125 compared with currently available NNRTIs and its activity against NNRTI
resistant virus are central to the ability of TMC125??¦to produce significantly better virological
responses than the placebo group in treatment experienced patients. The maintenance of
the response to 24 weeks without additionally clinically relevant tolerability concerns further
suggests that TMC125 is an encouraging new agent in this antiretroviral class."



In an accompanying Comment, Bernard Hirschel and Thomas Perneger (Geneva Hospital,
Geneva, Switzerland) argue that important questions have been left unanswered, including:
"Quality-of-life measurements, and detailed correlations between resistant genotype and
treatment success which may help gauge etravirine's prospects in individual patients."



thelancet

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FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC

Company used Internet to claim its unapproved products treat serious health conditions
The U.S. Food and Drug Administration announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases.


Wilderness Family is a manufacturer and distributor of conventional foods, dietary supplements and various salves, all branded under the Wilderness Family name. The company promoted several of its products for the treatment, cure, mitigation or prevention of disease by making claims on their products' labels, their Web site, and on other Web sites accessed by links found on their Web site.


"The FDA is acting to protect the American public from companies making unapproved disease treatment claims for their products," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "Claims made by Wilderness Family might distract consumers from seeking products that have been shown to be safe and effective in treating disease."



Wilderness Family has a history of promoting its products for the treatment of diseases, and recently referred customers to seemingly independent Web sites that were actually controlled by Wilderness Family. The Web sites claimed benefits for its products against diseases such as cancer, diabetes, heart disease, hyperthyroidism, chronic fatigue syndrome, HIV and AIDS, and arthritis.


Under the terms of the consent decree, the company and its owners, Kenneth H. Fischer and Annette C. Fischer, cannot promote claims related to their products' ability to fight diseases unless the products receive FDA approval as new drugs or satisfy FDA's investigational new drug requirements.


Wilderness Family and its owners also have agreed to remove disease claims from their products' labels, labeling and Web sites, as well as references to other Web sites that contain such claims. The company and its owners have also agreed to hire an independent expert to review the claims they make for all of their products and to certify to the FDA that they are not making any illegal claims.


The FDA can order Wilderness Family to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the Federal Food, Drug, and Cosmetic Act, or FDA regulations. Defendants are also required to pay $1,000 per violation per day if they fail to comply with the consent decree.


The decree was signed by Judge Donovan W. Frank on December 8, 2008 in the U.S. District Court for the District of Minnesota.


U.S. Food and Drug Administration

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How Anti-Depressants Create New Brain Cells

Antidepressants increase the presence of a growth factor in the brain, which then leads to a proliferation of new cells, according to a study by Yale School of Medicine researchers in this week's Proceedings of the National Academy of Sciences.


The study describes for the first time the molecular mechanisms and the identity of the protein, vascular endothelial growth factor (VEGF), which underlie the actions of antidepressants on new cell growth and behavior.


"One in five Americans have depression, yet the neural mechanisms underlying depression and the actions of antidepressants remain unknown," said Ronald Duman, senior author and professor of psychiatry at Yale. "These findings provide important, fundamental, and new information on the actions of these highly prescribed drugs. The data also has implications for understanding many stress related disorders."



Duman and Jennifer Warner-Schmidt, a former graduate student at Yale now at the Rockefeller Institute, found in a rodent study that VEGF levels are increased by chronic administration of either of two major classes of antidepressant medications. Conversely, blocking the effects of VEGF prevents new cell birth in response to the medications.


Duman said recent studies demonstrated that stress decreases the expression of VEGF in the hippocampus, a region of the brain involved in the control of emotion, mood, learning, and memory, and this could contribute to the atrophy and loss of cells caused by stress and depression.


In prior groundbreaking research Duman found that antidepressants increase the expression of growth factors in the hippocampus and other regions of the brain. Duman also found that antidepressants increase the birth of new neurons in the hippocampus.


According to Duman, future studies could look at VEGF and related pathways for genetic mutations that might contribute to depression, or make a person more susceptible to depression. VEGF signaling also could provide targets for the development of novel, faster acting, and more effective therapeutic agents.


PNAS: (online early edition pnas/cgi/doi/10.1073/pnas.0610282104)


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BBC Headroom Is Cracking Up For World Mental Health Day

This week, as the world's attention turns to issues of good mental health for Friday's World Mental Health Day, BBC Learning's own mental health and wellbeing campaign - BBC Headroom - celebrates with the transmission of Alastair Campbell's moving film, Cracking Up, some new faces at bbc/headroom and a dedicated action line: 08000 933 193[i].


Launched in May 2008, BBC Headroom is a two year mental healthand wellbeing project which aims to raise awareness of the importance of good mental health and de-stigmatise the problems surrounding the mental illness issues which face up to one in four of the population including anxiety stress, depression and nervous breakdown.


Following Losing It, Griff Rhys Jones' film charting his issues with anger, this Sunday (12th October) sees the transmission of Headroom's second film exploring a presenter's own personal mental health problems as Alastair Campbell talks about his 1986 nervous breakdown: the culmination of months of intensive stress at work, too much alcohol, and a myriad of complex issues which simply made his head explode. In Cracking Up he gives his first in depth account of this life changing event; revisiting the people, places, and landmarks of his breakdown and subsequent recovery.


Supporting the transmission of Cracking Up, viewers can find advice and support at BBC Headroom, including Alastair's interview with Headroom's online agony aunt, Ruby Wax. Since Headroom's inception, comedienne turned psychotherapist, Ruby Wax has hosted a weekly web-chat covering a range of different mental health and wellbeing issues including self harm, exam stress and bi-polar disorder. Welcoming Alastair to Ruby's Room, they discuss the nature of his nervous breakdown and how he now copes with his on-going depressive episodes, offering insight and advice to viewers who might find themselves in a similar situation. Ruby herself has a good understanding of these issues, not just from her psychotherapy training, but from her personal experience of depression - a subject that she discussed when Jo Brand paid a visit to Ruby's Room and puts Ruby in the hot seat for a change. bbc/headroom/rubys/index.shtml?rubysroom14.


Also for Cracking Up, bbc/headroom welcomes communication, confidence and assertiveness tutor, Jeremy Milnes as presenter of a new series of wellbeing guide, specifically focusing on breakdown, anger, happiness and loss.


Finally, to tie in with the transmission of Cracking Up BBC Headroom is launching a new mental health action line - 08000 933 193 - which will offer callers advice about where to get support, if they or someone they know, is going through a nervous breakdown or dealing with other mental health issues.


Campaign executive, Nina Bell said: "BBC Headroom wants to help reach those who need such support and to encourage everyone to take good care of their mental health as well as breaking down the stigma that still surrounds mental illness."


Cracking Up is a Liberty Bell production for BBC Two. It will transmit at 10pm on Sunday 12th October. Cracking Up is the second of five presenter led films on BBC Two commissioned as part of Headroom.


008000 933 193 - is a free phone number from a BT landline. Calls from other operators and mobile phone lines may incur a cost.


1. Headroom is a cross-platform campaign from BBC Learning to encourage people to look after their mental health and wellbeing. Headroom's main aim is to raise awareness of simple steps that people can take to help look after their own mental health and improve their lives. Be it exam stress, relationship headaches, insomnia, anxiety or depression, Headroom will provide on-going support and information, as well as offering individuals the chance to share their experiences in a safe environment. As well as its extensive online offering, the Headroom team take their practical advice on a tour in the Headroom Tent and undertake grassroots projects with local organisations such as libraries. There is also be a range of on-air programming across BBC TV and radio, creating bespoke programmes or integrated contributions to ongoing series, both factual and drama.


bbc/headroom

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Researchers Build Computer Simulations Of Laser-Nanoparticle Treatments For Cancer

Two lasers may be better than one when attacking cancer cells, according to a paper by Rice University scientists.



Yildiz Bayazitoglu, Rice's H.S. Cameron Chair Professor of Mechanical Engineering and an authority on heat transfer and fluid flow, and doctoral student Jerry Vera are using computer simulations to quantify the effect of heating nanoparticles with near-infrared lasers to kill cancer tumors without damaging healthy tissue.



They hope to raise the efficiency of destroying tumors by fine-tuning methods of heating them based on the size and composition of not only the tumor but also the surrounding tissue.



The paper summarizing their results, "Gold Nanoshell Density Variation with Laser Power for Induced Hyperthermia," is published in the January issue of the International Journal of Heat and Mass Transfer.



The researchers found that attacking a tumor with two lasers can heat it more thoroughly than a single laser. For tumors as large as one centimeter, simulations showed opposing lasers surgically inserted via fiber optics in a minimally invasive procedure produced the most uniform temperature profile in every case.



Lasers and nanoparticles are already being used to treat cancer. A Houston company founded by Rice scientists Jennifer West and Naomi Halas, Nanospectra Biosciences, Inc., is conducting human tests of a system that uses nanoshells heated by near-infrared lasers to kill tumors. Bayazitoglu, West and Halas are all part of Rice's Laboratory for Nanophotonics.



The Bayazitoglu group's approach would refine such treatment by taking into account the light-scattering properties of nanoparticles. Their concern is that nanoparticles near the surface of a tumor will block a laser from reaching those at the center.



"Think about it this way: If you're driving on a very foggy night, you can only see just so far no matter how good your headlights are," wrote Vera in an article about the research. "That's because the millions of small water droplets in the air absorb and scatter the light, deflecting the beams from your headlights before they can reflect off of whatever's ahead of you on the road.



"Nanoparticles dispersed within a tumor do exactly the same thing. They're very good at absorbing laser light and generating heat, but within particularly thick tumors, that same quality prevents a lot of the light from reaching deeper into the tissue."



Bayazitoglu said this phenomenon, called "extinction," is "highly undesirable." A uniform temperature profile of at least 60 degrees Celsius has to be created to kill the whole tumor. "Raising the temperature on one end but not the other will simply allow the tumor to re-grow, and that doesn't solve the problem - or cure the patient."



The density and placement of nanoparticles in the tumor are important, said Bayazitoglu. "Ideally, you should put nanoparticles at the center of the tumor, then kill it from the center out," she said.



Laser treatment may be effective even if nanoparticles are not used, she said. "If the tumor has good absorption properties, slow heating can do a good job of killing the cancer, because the heat has time to get inside. If you're doing that, sometimes it's better not to use nanoparticles."



With so many tissue types and the great variety of cancers people face, the importance of accurate simulations cannot be overemphasized, the researchers said. They hope the ability to calculate scenarios will allow doctors to find the best laser therapy to produce the perfect heating environment.


Notes:


The research was funded by the Alliances for Graduate Education and the Professoriate program through the National Science Foundation.



The paper can be viewed at: tinyurl/dx7qlj



An article by Vera on the research can be found here.

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Colorectal Cancer - MDC Researchers Identify Genetic Markers For Metastasis Formation

Previously, only a few genes had been associated with the formation of metastases in colorectal cancer. Now, researchers of the Max Delbr??ck Center for Molecular Medicine (MDC) Berlin-Buch and Charit?© - University Medicine Berlin, Germany, have identified 115 genes that are disregulated both in the primary tumor and in its metastases. In the future, their findings may help identify patients with aggressive tumors at an earlier stage (Gastroenterology 2009, doi:10.1053/j.gastro.2009.03.041).*



The National Cancer Institute estimates that, alone in the United States, 106,100 cases of colon cancer will occur and 49,920 patients will die both from colon and rectal cancer in 2009.



Beginning in glands in the bowel lining, colorectal cancer often remains undiscovered initially. "However, the main problem is not the primary tumor," explained the surgeon and clinical researcher Dr. Johannes Fritzmann, "but the dangerous metastases."



Metastases arise when single cells break off from the primary tumor and spread to other body regions via the blood vessels or the lymphatic system. In colorectal cancer, these cells usually settle in the liver, lungs, or lymph nodes. Since the affected patient seldom feels pain or shows other symptoms, the tumor is frequently not discovered until it has already formed metastases.



To investigate which genetic mutations favor the formation of metastases, the researchers analyzed 150 tissue samples of colorectal cancer patients with and without metastases. The researchers identified 115 genes that are falsely regulated in both the primary tumors and their metastases. In this way, the researchers succeeded in identifying a genetic signature which distinguishes tumors with metastatic potential from those that do not metastasize.



Of the 115 genes the researchers identified, they focused on one gene in particular: BAMBI. They discovered that this gene is more active in metastatic tumors and metastases than in non-metastatic tumors.



"Our investigations show that the particular gene BAMBI is associated with two import signaling pathways and thus promotes metastasis formation," Dr. Fritzmann said. "These signaling pathways (Wnt and TGF-beta) are, among other things, important in the developing embryo."



In the future the researchers want to investigate the role of the other 114 genes more closely, in order to better understand the individual steps of metastasis formation.



Aim - To predict at an early stage whether the tumor will spread


Dr. Fritzmann hopes the research findings will help determine early on whether a tumor has metastatic potential. The doctors could then adapt the therapy accordingly.



*A Colorectal Cancer Expression Profile that Includes Transforming Growth Factor ?? Inhibitor BAMBI Predicts Metastatic Potential



Johannes Fritzmann1,2,6, Markus Morkel1,4,6, Daniel Besser1,6, Jan Budczies3, Frauke Kosel1, Felix H. Brembeck1,5, Ulrike Stein1,2, Iduna Fichtner1, Peter M. Schlag1,2 and Walter Birchmeier1



1 Max Delbrueck Center for Molecular Medicine, 13125 Berlin, Germany


2 Dept. for Surgery and Surgical Oncology, Charit?© - University Medical School, 13125 Berlin, Germany


3 Institute for Pathology, Charit?© - University Medical School, 10117 Berlin, Germany


4 present address: Max Planck Institute for Molecular Genetics, 14195 Berlin, Germany


5 present address: Dept. of Hematology and Oncology, University G?¶ttingen, 37075 G?¶ttingen, Germany


6 contributed equally.





Barbara Bachtler

Press and Public Affairs

Max Delbr??ck Center for Molecular Medicine (MDC) Berlin-Buch

Robert-R?¶ssle-Stra??e 10

13125 Berlin, Germany

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Women Previously Diagnosed With Abnormal Cervical Cell Growth At Higher Risk For Recurrence And Invasive Cancer

New research from the UC Davis Center for
Healthcare Policy and Research has found that women who have been treated
for cervical intraepithelial neoplasia (abnormal cervical cell growth),
are at higher risk for a recurrence of the disease or invasive cervical
cancer.



The large, population-based study, which appears in the May 12 online
issue of the Journal of the National Cancer Institute, sheds new light on
the long-term risks of subsequent abnormal cell growth or invasive cancer,
and should help in the development of follow-up treatment guidelines for
women with a history of treatment for abnormal cells.



"We now have a much more clear idea of the risks of recurrent abnormal
cells and invasive cervical cancer over time after treatment of these
cells," said Joy Melnikow, Professor of Family and Community Medicine and
Associate Director of the UC Davis Center for Healthcare Policy and
Research, who led the study. "Recurrence risk depends on the grade of
abnormal cells that was initially treated, what treatment was used, and
the woman's age."



In the study, which used data from the British Columbia Cancer Agency
cytology database and was funded by a grant from the National Cancer
Institute, Melnikow and colleagues identified 37,142 women who were
treated for abnormal cells from Jan. 1, 1986 through Dec. 31, 2000.



They compared them with a group of 71,213 women with no previous diagnosis
of abnormal cells. Both groups were under active surveillance through
2004.



They found that risk of subsequent abnormal cells or cervical cancer was
associated with the type of treatment they received, their age, and the
initial grade of diagnosis. There are three levels of abnormal cervical
cells; grade 3 is the most severe. There is no standard treatment for
abnormal cells; at early stages, abnormal cells are monitored to determine
if they resolve without treatment.



At later stages, the type of treatment depends on several variables,
including the grade and distribution of the abnormal cells and whether the
patient has been treated previously.



According to the study, the risk of invasive cervical cancer and
recurrence of grade 2 or grade 3 abnormal cells was highest for women who
were older than 40, previously treated for grade 3, or treated with
cryotherapy, a common treatment method in which the abnormal cells are
frozen to stop their growth. Rates of recurrence at grades 2 and 3 were
lowest among women treated with cone biopsy, a method in which the
abnormal cells are removed surgically.



Melnikow said the findings could help guide physicians in making
recommendations about the intensity of follow up needed after treatment
for abnormal cells. In addition, she said the findings may help physicians
and patients in deciding which type of treatment for abnormal cells to
choose. She explained, for example, that while cryotherapy was associated
in the study with a higher risk of recurrence, it carries less risk of
other harmful effects than cone biopsy or loop electrical excision,
procedures which have been associated with pre-term delivery in women who
later become pregnant.
















This suggests that a younger woman with grade 2 abnormal cells who plans
to start a family might opt for cryotherapy, while an older woman with
grade 3 abnormal cells who is at greater risk for recurrence might opt for
loop excision or cone biopsy.



"These data may help inform that treatment discussion, because we know
more about how age and different treatments appear to influence risks,"
Melnikow said.



The study also found that the highest rates of recurrence of abnormal
cells were observed in the first six years after treatment; the majority
of those were identified in the first two years. Recurrence rates for
grade 2 or grade 3 abnormal cells during the 6-year period ranged from 2.3
percent in the lowest risk group to 35 percent in the highest risk group.
Overall incidence of cervical cancer in the abnormal cell group was 37
cervical cancers per 100,000 woman-years, compared with six cervical
cancers per 100,000 woman-years among women not previously diagnosed.



Melnikow pointed out that the study also has different implications for
health policy depending on the health system and resources. In developing
countries where cervical cancer screening and treatment are more limited
and death rates higher for cervical cancer, cryotherapy, a simpler and
less expensive treatment method for abnormal cells, is likely to be
preferred.



Melnikow said the next step is to compare different treatment and
surveillance strategies in terms of cost-effectiveness.



Source
UC Davis Health System

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New Data On Cell-Based Therapeutic Approaches To Cardiovascular Diseases To Be Presented At Conference On Cell Therapy

WHAT:



The Fifth International Conference on Cell Therapy for Cardiovascular Disease (IC3D) will include a new session on stem cells for non-cardiac organ injury. The session will include new data on stem cells for islet disease and diabetes, bone marrow cells for stroke patients, and treating Parkinson's disease with bone marrow cells.



Highlights from other sessions include the first human data using special bone marrow and adipose cells for heart attack patients and a discussion of the rapid advances in tissue engineering and how surgeons should prepare for this next stage of stem cell therapy.



WHY:



IC3D, one of the largest conferences of its kind with more than 60 internationally recognized faculty members, is a three-day comprehensive program dedicated to the evolving field of cell-based therapies for cardiac repair and regeneration. The theme of this year's meeting is "Cellular and Molecular Building Blocks: Strategies for Cardiovascular Reconstruction in 2009."



The conference encompasses all aspects of cell-based therapeutic approaches to cardiovascular diseases. Research presented at IC3D will touch upon clinical studies of stem cell repair of the heart, brain and peripheral arteries, new sources of adult stem cells and the status of embryonic stem cell research. Each day of the conference will focus on the following diseases and the future role of cell-based therapies.



PROGRAM SPECIFICS:



New sessions for 2009 will include:
Major advances in treating peripheral vascular disease


Combined cell and tissue regenerative methods


Changing the potential of stem cells: Why should we try? How do we do it?


New paradigms for the surgeon? How soon will engineered tissue be in the clinic?


Discoveries beyond the heart, including the brain and other organs


Expanded sessions on Industry Innovations in 2009

The full agenda can be found at: crf/Cell_Therapy/agenda.html.



WHO:



Warren Sherman, M.D., Conference Director, is Director of Cardiac Cell-Based Endovascular Therapies at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital and Columbia University Medical Center. Dr. Sherman is a renowned clinical investigator in the field of myocardial regeneration who pioneered a technique for injecting stem cells into the heart. In Rotterdam in May 2001, he performed the first catheter-based injection of stem cells into the heart of a patient with congestive heart failure due to a previous heart attack. At Columbia University Medical Center, researchers led by Dr. Sherman are using the patient's own myoblasts -- progenitor cells found in muscle -- to repair and replace injured cardiac tissue in a process called myogenesis. Dr. Sherman collaborates in studies to improve the outcomes of cell implantation with colleagues at Columbia University Medical Center, all of whom will be presenting their research at the conference.



WHEN:



January 13 - 16, 2009



WHERE:



The New York Academy of Medicine

New York, NY







For more information visit: crf/Cell_Therapy/



About CRF



The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1990, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in the subspecialty of interventional cardiology and endovascular medicine.

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Brain Tumors Coax Important Support From Nearby Immune System Cells

Developing brain tumors can coax assistance from nearby cells known as microglia, according to a new study from scientists at Washington University School of Medicine in St. Louis. The researchers have identified one protein made by microglia that helps accelerate tumor growth and are looking for others.


The results, published online this month in Human Molecular Genetics, come from a mouse model of neurofibromatosis 1 (NF1), a genetic condition that significantly increases childhood brain tumor risk. But senior author David Gutmann, M.D., Ph.D., the Donald O. Schnuck Family Professor of Neurology, says the findings also have implications for sporadic brain tumors, which affect many more people.


"Until now, we've never really had a good system for studying how microglia may contribute to general brain tumor formation," says Gutmann, who is director of the Neurofibromatosis Center and co-director of the neuro-oncology program at the Siteman Cancer Center at Washington University and Barnes-Jewish Hospital. "We're going to use this model to better understand how brain cells that become tumors interact with microglia, and to probe how we might block those interactions."


Gutmann hopes to create approaches for shutting down microglia, which exist both in a resting state and an activated state. Tumors likely need microglia to be activated before they can convince them to send out growth signals. The tumor then exploits these signals to enable its rapid growth. If scientists can block microglia activation, they place the tumor's potential partner in crime out of its reach.


"From a therapeutic standpoint, we're very focused in cancer therapy on poisoning the cancer cell," Gutmann says. "But why not also deprive the cancer cell of the growth signals it receives from the normal surrounding tissue? These cells may actually decide whether a tumor forms at all and whether it continues to grow."


To learn more about the neighboring cells' effects on brain tumors, Gutmann turned to NF1, which affects more than 100,000 people in the United States. Gutmann has studied the condition for years both to help improve NF1 treatment and to develop insights into brain tumors generally. As a part of that research, his lab developed a mouse model of NF1.


Brain tumors in human patients and in the mouse model arise from brain support cells known as astrocytes. To begin the new study, Gutmann and his postdoctoral fellow Girish C. Daginakatte, Ph.D., studied these brain tumors early in their development to see if any other cell types were consistently nearby. They found microglia, a cell type they had previously noted in human tumor samples.


Microglia are similar to monocytes, immune system cells that circulate throughout the body. Scientists are still debating the role of microglia.















"I think people recognize now that microglia can be both good guys and bad guys," Gutmann says. "We've shown that they can definitely be subverted into a bad guy role by tumors."


When researchers gave the mice drugs that dampen immune system function, blocking activation of the microglia, tumor growth slowed. To get a sense for what the microglia was making that boosts tumor growth, they compared the proteins produced by microglia from the mouse model and microglia from normal mice.


Among other differences, microglia from the mouse model made more of an enzyme called hyaluronidase. Other scientists had previously identified hyaluronidase as a contributor to processes that trigger healing and regrowth after brain and spinal cord injury. In a series of test tube experiments, Gutmann showed that hyaluronidase can promote astrocyte growth, and that inhibiting microglia production of hyaluronidase slowed their growth-promoting effects.


"Now we have to wait for pharmaceutical scientists to develop inhibitors of hyaluronidase activity that can be used as potential treatments," Gutmann says. "In the meantime, though, we'll be looking at other factors made by microglia to see if they're also contributing to brain tumor growth as well as searching for ways to deactivate microglia."


Daginakatte GC, Gutmann DH. Neurofibromatosis-1 (Nf1) heterozygous brain microglia elaborate paracrine facts that promote Nf1-deficient astrocyte and glioma growth. Human Molecular Genetics, online publication.


Funding from the Department of Defense supported this research.


Washington University School of Medicine's full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked fourth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.


Washington University in St. Louis

One Brookings Dr., Campus Box 1070

St. Louis, MO 63130

United States

wustl

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GE Healthcare Partners With Leading Experts To Create Fetal Heart Rate Monitoring Interpretation And Management Education Program

GE Healthcare, a leading provider of maternal and infant care devices, announced today an innovative clinical education program, designed specifically for physicians, midwives, nurses, residents and students in obstetrics, to enhance their knowledge of fetal heart rate monitoring. GE's Electronic Fetal Heart Rate Monitoring Interpretation and Management education program, developed in partnership with Frank Miller, M.D., FACOG and David Miller, M.D., FACOG, both leading experts in the field of fetal monitoring, emphasizes the importance of using standardized NICHD terminology to describe, communicate and interpret abnormal fetal heart rate tracings.


Electronic fetal heart monitoring has been in use for 40 years. Yet, until recently there has been no agreement on standard definitions and nomenclature for interpreting fetal heart rate patterns.


"By reinforcing NICHD standardized definitions endorsed by AWHONN, ACOG and ACNM this program gives clinicians the tools they need to increase their knowledge to visually interpret fetal heart rate patterns," said Michael Reed, manager of GE Healthcare's Global Education for Clinical Systems Service. This interdisciplinary education provides a clear path to better communication and increased patient safety."


"This program has managed to integrate the underlying physiology of fetal heart rate interpretation with appropriate use of the NICHD nomenclature, making it an excellent tool for education as well as review. As an electronic fetal monitoring educator, I am always looking for innovative methods to reinforce training in fetal monitoring, and this interactive model is perfect," said Lisa A. Miller, CNM, JD, President, Perinatal Risk Management and Education Services in Chicago.


As identified by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the lack of a common language to describe and interpret electronic fetal heart rate patterns has contributed to inconsistent interpretation and management, which can jeopardize patient safety. JCAHO recommended the use of standardized terminology and protocols to communicate and interpret abnormal fetal heart rate tracings.


Language and terminology is standardized, facilitating communication, thus helping to reduce errors and improve patient safety, which may result in better outcomes. This enables the health care enterprise to meet patient safety standards set by JACHO and other accrediting groups.


The e-learning program can be accessed from any computer with an Internet connection, meaning, courses are available 24 hours a day, seven days a week. GE's Fetal Heart Rate Monitoring Interpretation and Management Program is a clinical education program and does not endorse or support any medical device manufacturer.


Drs. Miller developed the Fetal Heart Rate Monitoring educational program for clinical professionals. The Millers are practicing obstetricians-gynecologists, as well as maternal fetal medicine sub-specialists. Both did their fellowship in maternal-fetal medicine at the University of Southern California. The Millers have maintained a strong interest in teaching and research in electronic fetal monitoring.















"In 2005 and 2006, ACOG, AWHONN and ACNM endorsed the standardized definitions of fetal heart rate patterns proposed by the NICHD in 1997," said Dr. David Miller. "Agreeing to use a common language to describe fetal heart rate tracings paves the way for much needed standardization of fetal heart rate interpretation and management. The ultimate goal is to optimize outcomes and to minimize potential sources of preventable error in intrapartum fetal heart rate monitoring."


Dr. David Miller speaks frequently on perinatal risk management and standardized terminology. Numerous requests for an educational program from doctors and nurses in hospitals across the country led the Millers to partner with GE to create the e-learning program, making it more accessible and available to hospitals that need this vital information.


For additional information about the program, visit gehealthcare/fhr.


About GE Healthcare


GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.


GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

GE Healthcare

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New Class Of Lipids Suggests New Treatment Approach For Heart Attacks

Researchers have discovered one potential mechanism by which briefly cutting off, then restoring, blood flow to arteries prior to a heart attack lessens the damage caused, according to a study published in the journal Cardiovascular Research. The new mechanism points to how future drugs could provide protection ahead of heart attacks and strokes for those at highest risk. In the nearer term, the work may help to prevent damage caused as U.S. heart surgeons temporarily cut off blood flow 450,000 times each year to perform coronary artery bypass graft surgeries. Lastly, the discoveries hold clues to the value of the Mediterranean diet beyond red wine.



In severely diseased coronary arteries, fatty deposits in blood vessel walls become more likely to rupture, which releases proteins into the blood that cause blood clots and cut off blood flow. When a vessel becomes completely blocked (ischemia) the downstream tissue begins to die for lack of oxygen and nutrients. Worse yet, when blood flow is restored (reperfusion), the returning blood throws off cellular chemistry, creating as a side-product a burst of highly reactive "free radicals" that tear apart cell components and cause cells to self-destruct. Later in the process, the immune system attacks the cardiac tissue damaged by ischemia and reperfusion, causing inflammation which can lead to heart failure.



In 1986 then medical student Chuck Murry at Duke University first described a technique called ischemic preconditioning (IPC), which quickly cuts off then restores blood flow to the heart. He found that IPC somehow protected heart tissue against the damage caused by subsequent, prolonged blood vessel blockages. An emerging theory holds that this natural early warning system of IPC has evolved to protect against heart attack. Labs worldwide are seeking to re-create or strengthen this natural protection against ischemia/reperfusion (IR) injury. In the current study, researchers for the first time determined that IPC caused more of a key molecule, nitro-linoleic acid (LNO2), to be made in ischemic cells.



"LNO2 appears to be important in the mechanism by which IPC triggers the body's natural defense mechanisms against heart attack before the major attack comes," said Paul S. Brookes, Ph.D., associate professor of Anesthesiology and of Pharmacology and Physiology at the University of Rochester Medical Center. "Obviously, this natural response, when it follows a major heart attack, is often too little too late. Our hope is that boosting the effect in patients at high risk, perhaps by administering LNO2 beforehand, will reduce heart attack damage in the future. Even sooner, we may be able dramatically reduce reperfusion injury suffered in surgical settings."
















Study Details



Going into the study, the mechanisms underlying IPC protection were controversial, but a consensus had emerged recently that mitochondria were involved. The cell's powerhouse, mitochondria use oxygen to convert nutrients into cellular energy supply.



As they do so, they create a gradient of protons across their membranes. When the gradient becomes too large, it triggers the mitochondria to use oxygen to generate free radicals. The problem gets much worse when blood returns to a vessel after a blockage, bringing with it a surge of oxygen and nutrients.



It has long been thought that a group of proteins in the mitochondrial membrane act as a "safety valve" by dissipating too large proton gradients when necessary, which slows free radical generation. The current study identified a novel mechanism involving LNO2, by which IPC turns on this safety valve.



Given their results, the authors propose the following protective mechanism: temporary ischemia causes the generation of nitrated lipids inside the mitochondria via currently unknown mechanisms involving metabolites of the gas nitric oxide (NO). These lipids, including LNO2, then become attached to two proteins - adenine nucleotide translocase and uncoupling protein 2 - changing their shape such that they allow a proton leak across the mitochondrial membrane. The leak lowers the proton gradient just enough to lessen free radical production.



While the current study only looked at the immediate effects of LNO2 treatment, the literature suggests that LNO2 also limits the misplaced immune response seen after reperfusion, suggesting a dual treatment effect. Past studies found that LNO2 inhibits Nfkappa B, a protein known to switch on genes that drive inflammation. LNO2 also activates peroxisome proliferator activated receptor gamma and heme oxygenase 1, both of which block inflammation.



The major finding of the study is that LNO2 is formed naturally in mitochondria during IPC in an isolated rat heart, and that adding extra LNO2 protects heart muscle cells from IR injury. The team measured the ability of isolated rat heart cells to survive ischemia using a dye that the live cells keep out, but that dead cells take in. That enabled researchers to count how many cells survived with and without LNO2 added.



In normal cells following ischemia 70 percent died, but for those receiving extra LNO2 (0.5 micromolar), only 30 percent died. The amount of the LNO2 added was not much more than naturally occurs, suggesting its effect is "extremely potent," researchers said. The LNO2-related proton leak also occurs at the protein level within seconds, a vital quality of any future therapy, considering that IR injury greatly increases with each second it is allowed to proceed.



Brookes is part of the Mitochondrial Research & Innovation Group (MRIG) at the Medical Center, which last year reported in the Journal of Molecular and Cellular Cardiology on the design and testing of a series of patented nitric oxide donors that break down and release NO only within the mitochondria, and protect the heart from ischemia. The team believes these NO donors may work in part by increasing LNO2 supply. In the acute setting, such drugs may offer an advantage over standard nitric oxide donors like nitroglycerin, which increase blood flow in diseased arteries by causing them to dilate throughout the body. Standard NO donors also depress cardiac function by decreasing the pressure of blood returning from the body back into the heart. Early tests in a mouse model have confirmed that the new MRIG NO donor drugs are cardioprotective in-vivo, and do not cause system-wide vessel dilation side effects.



Bruce Freeman, Ph.D., chair of the Department of Pharmacology & Chemical Biology at the University of Pittsburgh School of Medicine, also led the study. Other contributors included postdoctoral fellow Sergiy Nadtochiy, Ph.D. in Rochester, and Paul Baker, Ph.D. research assistant professor in Pittsburgh.



"Our interest in this area stems from the fact that many different stimuli appear to funnel down into the mitochondria where they may trigger LNO2 production, any of which may suggest a new way to prevent damage," Freeman said. "Along with IPC, olive oil has been shown to produce LNO2 in the stomach, offering an explanation for the value of the Mediterranean diet."

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Fabio Cannavaro Supports World Heart Day, Sunday 24 September, 2006

Controlling major risk factors such as physical inactivity, an unhealthy diet and tobacco use could prevent 80% of heart disease and stroke1and help keep the heart healthy. This is why this year's World Heart Day campaign asks: "How Young is Your Heart?"


"I know my heart is the strongest, most important muscle in my body and a winning performance depends on its vitality," explains Fabio Cannavaro, Italian Captain of FIFA World Cup Champions. "Having a healthy diet and taking regular exercise will help to keep my heart young and my career long."


World Heart Day is run by the World Heart Federation's member organizations in more than 100 countries. Activities on the day include health checks, walks, runs, jump rope, fitness sessions, public talks, stage shows, scientific forums, exhibitions, concerts and sports tournaments. Last year in Singapore for example, a World Heart Day heart fair attracted over 60,000 participants who took part in health screenings, aerobics classes, health quizzes, exhibits, school performances, nutritional counselling and food sampling. Similar events will be taking place this year asking participants: "How Young is Your Heart?"


"Heart disease and stroke is the world's largest killer, claiming 17.5 million lives a year. Eighty per cent of these lives are from populations in low- and middle-income countries, many amongst people of working age" said Professor Sidney Smith, University of North Carolina and Chairman Scientific Advisory Board, World Heart Federation.


Physical activity is vitally important to maintain a healthy heart. Running for one hour or more each week could reduce the risk of heart disease by 42%. A brisk walking of
30 minutes each day has been found to reduce the risk of heart disease by about 18%2 and stroke by about 11%. Commuting to work by foot is a practical way of achieving this level of physical activity.



Physical inactivity increases the risk of obesity and overweight, diabetes and hypertension which make heart age run faster. The heart needs regular exercise to keep it pumping blood efficiently with every heart beat. Regular activity and its impact on associated risk factors helps to slow down the narrowing of the arteries to the heart and brain, encourages the body to use up excess stored fat, can help to reduce high blood pressure, improves "good" cholesterol levels (HDL cholesterol) and maintains normal blood glucose levels.















It is also important to balance calories consumed with calories burned to help maintain a healthy heart for life. A balanced diet includes plenty of fruits and vegetables, whole grain products, lean meat, fish and pulses, alongside low-fat and fat-free products. Unsaturated soft margarines and oils such as sunflower, corn, rape-seed and olive oil are preferred to saturated fats.


Tobacco use is one of the most important risk factors to control. Quitting will help to keep the heart young as it helps maintain "good" cholesterol levels, reduces the levels of blood clotting and overall, decreases the chance of a sudden blockage of a blood vessel. According to the Framingham Heart Study, life duration is substantially shortened by tobacco users. Non-smokers may live about 8 years longer than smokers.4


"If you are a smoker, try to quit or avoid smoking in the presence of your children. Allow them to live in a smoke-free environment," said Professor Smith. "Smokers put their own lives at risk, but they also endanger the lives of those around them, with passive smoking increasing the risk of coronary heart disease by 25-30%.5 Breathing second-hand smoke for even a short time can have adverse effects on the cardiovascular system, increasing the risk of heart attack.6


"Controlling major risk factors can prevent heart disease and stroke and thereby keep the heart healthy," said Dr Sania Nishtar, Chair, Foundations' Advisory Board, World
Heart Federation. "The good news is that it's never too late to adopt a heart healthy lifestyle. By asking everyone to think about the age of their hearts on World Heart Day we're encouraging the world's population to adopt a heart-healthy lifestyle."


To find out what activities will be taking place in each country on World Heart Day visit: worldheartday.


About the World Heart Federation


The World Heart Federation, a nongovernmental organization based in Geneva, Switzerland, is committed to helping the global population achieve a longer and better life through prevention and control of heart disease and stroke, with a particular focus on low- and middle-income countries. It is comprised of 189 member societies of cardiology and heart foundations from over 100 countries covering the regions of Asia-Pacific, Europe, the Americas and Africa. For further information visit: worldheart


1 Preventing Chronic Disease, a Vital Investment: WHO Report published 2005

2 Tanasescu M et al. JAMA 2002 October 23, 288: 1994-2000

3 Hu et al Stroke 2005;36:1994-1999

4 Mamun AA et al. Eur Heart J. 2004 Mar;25(5):409-15

5 Law et al BMJ 1997 October 18, 315:973-980

6 Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General US Department of Health and Human Services. June 2006

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Naturlose(R) Dosage Test Shows Positive Effect

Spherix Incorporated
(Nasdaq: SPEX) has successfully completed its dose range-finding study,
allowing it to continue with its Phase 3 clinical trial of Naturlose as a
treatment for type 2 diabetes (see Spherix news releases dated May 23,
2006, and August 10, 2006). The tests were done on human subjects to
establish the appropriate dosage and timing to be used in the upcoming
trial. The Company will now recruit patients for the trial, which will take
place in Australia and the United States. Company officials expect that the
first participants will begin the Phase 3 clinical trial by April 2007.



"The test results so far have been positive," said Spherix President
Richard Levin. "Not only did they determine the dose and timing for the
trial, but the results corroborate what we have seen in smaller, previous
tests -- that Naturlose has a beneficial effect on modulating postprandial
blood glucose, an important factor in the treatment of Type 2 diabetes. We
are moving forward with confidence that we have a scientifically sound
foundation on which to complete the Phase 3 trial, and to anticipate a
favorable outcome."



Levin said that the Company's recently announced settlement of a
contract dispute (see Spherix's PR released earlier today) in its
reservations business will bolster its financial ability to support
Naturlose. In that settlement, Spherix agreed to accept $6 million to end
the longstanding legal dispute over the award of the National Recreation
Reservation Service contract. Spherix intends to use a portion of that
payment to support its efforts to develop Naturlose as a marketable
product. Spherix believes these funds, along with existing cash, will
ensure its ability to complete the Phase 3 clinical trial.



If the Phase 3 trial establishes that Naturlose is an effective
treatment for diabetes, Spherix will prepare a New Drug Application (NDA)
for presentation to the Food and Drug Administration (FDA). FDA approval
would give Spherix the right to market Naturlose as a diabetes drug.
Naturlose has already been shown to be safe.



Certain statements contained herein are "forward looking" statements as
defined in the Private Securities Litigation Reform Act of 1995. Because
such statements include risks and uncertainties, actual results may differ
materially from those expressed or implied. Factors that could cause actual
results to differ materially from those expressed or implied include, but
are not limited to, those discussed in filings by the Company with the
Securities and Exchange Commission, including the filing on Form 8-K made
on March 3, 1999.


Under its motto, "A World of Solutions," Spherix's mission is to create
value and increase shareholder wealth through innovations that benefit our
clients and the human condition. Spherix offers innovations in information
technology, knowledge management, and biotechnology.


Spherix Incorporated

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Type Of Breast Reconstruction Impacts Radiation Therapy Outcomes

For breast cancer patients who underwent a mastectomy who undergo radiation therapy after immediate breast reconstruction, autologous tissue reconstruction provides fewer long-term complications and better cosmetic results than tissue expander and implant reconstruction, according to a study in the November issue of the International Journal of Radiation Oncology*Biology*Physics, the official journal of the American Society for Therapeutic Radiology and Oncology.


After undergoing a mastectomy (surgical removal of the breast), many women choose to have a breast reconstruction procedure performed immediately to better cope with the psychological and esthetic side effects of the surgery. However, the reconstruction can complicate radiation therapy treatments and sometimes radiation can negatively affect the outcome of reconstruction and increase the risk of long-term complications.


With radiation therapy increasingly becoming the standard of care for high-risk breast cancer patients after mastectomy, this can cause a problem for both patients and their radiation oncologists.


Researchers at the Department of Radiation Oncology at Long Island Radiation Therapy in Garden City, N.Y., the Department of Surgery at Long Island Jewish Hospital in New Hyde Park, N.Y., the Department of Surgery at North Shore University Hospital in Manhasset, N.Y., and the Department of Surgery at Winthrop University Hospital in Mineola, N.Y., sought to determine if the type of reconstruction performed on women who were receiving radiation after a mastectomy had an impact on their long-term outcomes.


Two types of reconstruction are available for patients undergoing mastectomy for breast cancer: ATR (autologous tissue reconstruction), which involves the placement of a tissue flap - most commonly from the transverse rectus abdominus muscle - as a breast mound, and TE/I (tissue expander and implant reconstruction), which involves placing an inflatable tissue expander over the chest wall and exchanging it for a permanent implant at a later date.


This study involved the largest reported series of patients who sequentially underwent mastectomy, immediate reconstruction and postmastectomy radiation therapy. Ninety-two patients were observed for 38 months following their reconstruction and radiation treatments, and researchers found that ATR is better tolerated by breast cancer patients because it is associated with fewer long-term complications and better cosmetic results than TE/I.


None of the 23 ATR patients required surgical intervention, while 33 percent of TE/I patients needed surgery to correct a problem with their reconstruction. Eighty-three percent of ATR patients reported acceptable cosmetic outcome, as opposed to only 54 percent of TE/I patients.


"This study is useful for patients who are candidates for either ATR or TE/I and are making a decision with regards to reconstruction technique," Jigna Jhaveri, M.D., lead author of the study and a radiation oncologist at Advanced Radiation Centers of New York in Hauppauge, N.Y., said. "Our study provides evidence that patients who undergo autologous tissue reconstruction and radiation therapy have fewer long term complications and better cosmetic outcomes than those who undergo tissue expander/ implant reconstruction and radiation therapy."


ASTRO is the largest radiation oncology society in the world, with 10,000 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to improving patient care through education, clinical practice, advancement of science and advocacy. For more information on ASTRO, visit astro. Visit rtanswers to learn more about radiation therapy.


ASTRO

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Individuals Who Apply Pesticides Are Found To Have Double The Risk Of Blood Disorder

A study involving 678 individuals who apply pesticides, culled from a U.S. Agricultural Health Study of over 50,000 farmers, recently found that exposure to certain pesticides doubles one's risk of developing an abnormal blood condition called MGUS (monoclonal gammopathy of undetermined significance) compared with individuals in the general population. The disorder, characterized by an abnormal level of a plasma protein, requires lifelong monitoring as it is a pre-cancerous condition that can lead to multiple myeloma, a painful cancer of the plasma cells in the bone marrow. The study will appear in the June 18 issue of Blood, the official journal of the American Society of Hematology.


"Previously, inconclusive evidence has linked agricultural work to an increased multiple myeloma risk. Our study is the first to show an association between pesticide exposure and an excess prevalence of MGUS," said lead author Ola Landgren, MD, PhD, of the National Cancer Institute (NCI), which is part of the National Institutes of Health, U.S. Department of Health and Human Services. "This finding is particularly important given that we recently found in a large prospective cancer screening study that virtually all multiple myeloma patients experienced a MGUS state prior to developing myeloma."


"As several million Americans use pesticides, it's important that the risks of developing MGUS from the use of pesticides is known," added senior study author and NCI investigator Michael Alavanja, DrPH.


The blood of study participants, who were individuals licensed to apply restricted-use pesticides, was assessed for MGUS prevalence. The median age of participants was 60 years (range 30-94 years), and all lived in either Iowa or North Carolina. Participants also completed questionnaires providing comprehensive occupational exposure information for a wide range of pesticides, including information such as the average number of days of pesticide use per year, years of use, use of protective gear while applying pesticides, and pesticide application methods. Information on smoking and alcohol use, cancer histories of the participants' first-degree relatives, and other basic demographic and health data were also obtained. Individuals with prior histories of lymphoproliferative malignancies (such as multiple myeloma or lymphoma) were excluded. Cancer incidence and mortality were monitored annually, and, after five years, follow-up interviews were conducted to update the information about participants' occupational exposures, medical histories, and lifestyle factors.


For comparison, data were obtained from a large MGUS-screening study conducted by the Mayo Clinic, and the results from the pesticide-exposed group were compared with the assessments of 9,469 men from the general population of Olmsted County, Minnesota. The two groups were similar in terms of age, race, and educational attainment. Because of the low prevalence of women among workers who apply pesticides, women were excluded from the study.















In the pesticide-exposed group, no MGUS cases were observed among those who were less than 50 years of age, but the prevalence of MGUS in those older than 50 was 6.8 percent, which is 1.9 times higher than the general population study group of men in Minnesota.


The researchers also evaluated the potential association between MGUS prevalence and 50 specific pesticides for which usage data were known. Of the chemicals studied, a significantly increased risk of MGUS was observed among users of dieldrin (an insecticide), carbon-tetrachloride/carbon disulfide (a fumigant mixture), and chlorothalonil (a fungicide). The MGUS risk for these agents increased 5.6-fold, 3.9-fold, and 2.4-fold, respectively. Several other insecticides, herbicides, and fungicides were associated with MGUS, but not significantly.


"There is great concern regarding the increase in frequency in mature B-cell malignancies in the Western world and what may be the cause of this. A number of reports in the past have linked exposure to pesticides with increased risk of these types of cancers, but the present study is the first to link agricultural work to a pre-malignant condition," said John G. Gribben, MD, DSc, Professor of Experimental Cancer Medicine at Barts and the London School of Medicine, who is not affiliated with the study. "It is vital to assess the risk of workplace exposure and disease, and the results lend further support to providing safe workplace practices to limit exposure to potential carcinogens."


"Our findings are intriguing," stated Dr. Landgren. If replicated in a larger sample from our study and other large studies, further work should focus on gaining a better understanding of the molecular basis of MGUS and multiple myeloma. Ultimately, this will result in the identification of novel molecular targets involved in the progression from MGUS to multiple myeloma and in the development of targeted therapies."


The American Society of Hematology is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology. In September, ASH launched Blood: The Vital Connection, a credible online resource addressing bleeding and clotting disorders, anemia, and cancer. It provides hematologist-approved information about these common blood conditions including risk factors, preventive measures, and treatment options.

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Nearly 80% Of Men Are Unaware Of Their Breast Cancer Risk Despite Having A Family History Of The Disease

A study, published in the October issue of the American Journal of Nursing (AJN), revealed that nearly 80% of men are unaware of their breast cancer risk despite having a family history of the disease. One hundred percent of respondents also reported that their healthcare provider did not discuss the disease with them. AJN, the leading voice of nursing since 1900, is published by Lippincott Williams & Wilkins, part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, and pharmacy.


"This study provides a first step toward an improved understanding about men's perceptions and knowledge of male breast cancer," said author Eileen Thomas, assistant professor at the College of Nursing, University of Colorado Denver and advisory board member of the Colorado Department of Public Health and Environment's Breast and Cervical Cancer Screening Program. "While further research with larger racial and ethnic samples is needed, these findings offer a starting point for the development of evidence-based, gender-specific, health promotion and disease prevention interventions for men."


The Study


This qualitative study used a descriptive study design to explore awareness and knowledge of male breast cancer among 28 English-speaking men, all of whom had no history of breast cancer but had at least one maternal blood relative with the disease. All participants were asked to describe their awareness of male breast cancer, what they knew about the disease, and how they thought awareness of male breast cancer could be increased among health care providers and the lay public. Findings included:


- Twenty-two men (79%) reported that they were not aware, and were surprised to find out, that men could get breast cancer. A majority of them could not identify any symptoms other than a lump in the breast.


- All 28 (100%) reported that their primary health care provider never mentioned male breast cancer to them even though all may be at higher risk for the disease because of family history.


- Twelve (43%) indicated that being diagnosed with breast cancer might cause them to question their masculinity.


- Socioeconomic status, as indicated by occupation and religious affiliation, were not indicators of participants' awareness or knowledge of male breast cancer, although three were health care providers.


According to the American Cancer Society (ACS):


- While relatively uncommon in men, breast cancer is more likely to be diagnosed at a more advanced stage in men than in women; men also have a higher occurrence of invasive ductal carcinoma, which accounts for at least 80% of all male breast cancer cases.


- Although the rate of female breast cancer has been declining, the number of breast cancer cases in men relative to the population has been fairly stable over the last 30 years.


- Worldwide, approximately 1.3 million women are diagnosed with breast cancer annually; this has significant implications for men, since 15% to 20% of men with breast cancer have a blood relative with a history of the disease.


"Male breast cancer is uncommon and so has largely been ignored by the media, general population and health care community," said Maureen Shawn Kennedy, MA, RN, editorial director and interim editor-in-chief of AJN. "Still, nurses in all settings need to raise awareness about male breast cancer among men as well as women, especially those men at high risk for the disease."


Source.

Wolters Kluwer Health: Lippincott Williams & Wilkins

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FluoroPharma Announces Commencement Of Phase I Clinical Trial For BFPET(TM), Myocardial Perfusion Imaging (MPI) Tracer For PET

FluoroPharma Inc., a company
developing breakthrough cardiovascular molecular imaging agents for the
Positron Emission Tomography (PET) market, announced commencement of Phase
I clinical trials for BFPET, following institutional review board (IRB)
approval of the proposed studies. The Phase I trial is a single center,
open label study, designed to evaluate safety, distribution and dosimetry
of BFPET as a PET tracer for myocardial perfusion imaging in healthy
subjects. The study will be led by Dr. Alan Fischman, Professor of
Radiology at Harvard Medical School and former Director of the Nuclear
Medicine Division at Massachusetts General Hospital. BFPET is
FluoroPharma's second cardiovascular PET agent to enter clinical trials.


BFPET is a PET blood flow imaging agent, for use in classic
"rest-stress" cardiac testing. More than 9 million Americans each year
undergo myocardial perfusion imaging, the standard test to assess coronary
artery disease (CAD). BFPET, as a PET imaging tracer, may have a
significant advantage due to its potential to improve the sensitivity and
specificity of CAD diagnosis and to provide information on myocardial
mitochondrial damage. "This agent, if successful, should improve CAD
diagnosis and follow-up of therapy and intervention, and broaden the
utility of PET as an imaging modality," said Dr. David Elmaleh,
FluoroPharma's Chairman and Scientific Founder. "BFPET has performed well
in animals with a target-to-blood ratio of 70:1, and we look forward to
evaluating the agent in human studies."



"We are delighted to have our second product enter clinical trials,"
said Dr. Ljiljana Kundakovic, FluoroPharma's President. "BFPET's progress
follows on the tail of CardioPET, an agent for the detection of metabolic
integrity of the heart, which recently completed a Phase I safety
evaluation in normal healthy volunteers and cardiac patients. FluoroPharma
has the potential to significantly impact diagnosis of cardiovascular
disease with multiple PET imaging agents targeting a wide range of
indications."



About FluoroPharma



FluoroPharma is a molecular imaging company engaged in the discovery
and development of proprietary products for the PET market. FluoroPharma is
advancing three proprietary products for assessment of acute and chronic
forms of coronary disease. These agents have been designed to rapidly
target either the myocardial cells within the heart or inflamed plaques
within the coronary arteries. fluoropharma



This release may contain forward-looking statements within the meaning
of the federal securities laws. Such forward-looking statements reflect,
among other things, management's current expectations, plans and
strategies, and anticipated financial results, all of which are subject to
known and unknown risks, uncertainties and factors that may cause our
actual results to differ materially from those expressed or implied by
these forward-looking statements. Many of these risks are beyond our
ability to control or predict including the company's need for additional
funds, the company's dependence on a limited number of imaging compounds,
the early state of the products the company is developing, uncertainties
relating to clinical trials and regulatory reviews, competition and
dependence on collaborative partners, the company's ability to avoid
infringement of the patent rights of others, and the company's ability to
obtain adequate patent protection and to enforce these rights. Because of
these risks, uncertainties and assumptions, you should not place undue
reliance on these forward-looking statements. Furthermore, forward-looking
statements speak only as of the date they are made. FluoroPharma does not
undertake any obligation to update or review any such forward-looking
information, whether as a result of new information, future events or
otherwise.


FluoroPharma Inc.

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Biomodels' Oral Mucositis Expertise Speeds FDA Approval For ActoGeniX's Phase 1b Trial Of AGO13 In Cancer Patients

Biomodels LLC, a preclinical research organization specializing in cancer support care, announced that its customized research program allowed ActoGeniX NV, a development stage biopharmaceutical company, to rapidly attain Food and Drug Administration (FDA) approval for Phase 1b clinical trials of AGO13 in cancer patients with oral mucositis.


There is currently no effective cure for the severely painful and debilitating inflammation and ulceration of the mucous membranes lining the mouth that makes eating, drinking and speaking difficult or impossible.


Oral mucositis, can affect up to 100 percent of cancer patients undergoing high dose chemotherapy.


The FDA approval permits ActoGeniX to initiate a phase 1b clinical trial in six major oncology centers in the United States. AGO13 could become the first approved therapy for oral mucositis in patients undergoing treatment of solid tumors or head/neck cancers, according to ActoGeniX.


"The speedy approval of our drug application for AGO13 from the FDA was clearly the result of our successful collaborative efforts with Biomodels scientists who worked closely with us in a complex process involving the development of innovative, high quality platforms," said Dr. Mark Vaeck, CEO of ActoGeniX.


The preclinical data package that was developed enabled us to identify how AGO13 could be used clinically, " he said. "We can now seamlessly translate Biomodels' research into our clinical trials, thus speeding up the drug development process."


Edward Fey, CEO of Biomodels said, "We are delighted that our collaboration with ActoGeniX will speed the development of an effective therapy for cancer patients suffering from the ravages of oral mucositis. Biomodels was able to provide an innovative and customized program to ActoGeniX. This close collaboration resulted in a very successful outcome."


About Biomodels


Biomodels, a preclinical contract research organization founded in 1997, has developed and conducted more than 1000 preclinical trials for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation, therapy, and inflammatory diseases.


The company specializes in (non-GLP) predictive studies that evaluate efficacy and define mechanism of action, enabling clients to expedite the drug discovery process. Biomodels' preclinical studies anticipate clinical objectives and enable organizations to rapidly achieve preclinical milestones.


About ActoGeniX


ActoGeniX is a biopharmaceutical company focused on the development and commercialization of ActoBiotics(TM), a novel class of orally available biopharmaceuticals for the targeted treatment of severe diseases with high medical needs. ActoBiotics(TM) represent a novel concept for oral administration of therapeutic proteins, and are designed to be safer and more effective than injectable biopharmaceuticals.


ActoGeniX was founded in 2006 as a spin-off from VIB and Ghent University in Belgium. The company is headquartered in Ghent and has approximately 40 employees, half of whom are PhD's, MD's, or PharmD's.

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Cerebral Embolic Protection And Carotid Stent Systems

High-risk surgical patients in community hospital settings can safely benefit from the use of new embolus-removing and stent-inserting systems, according to a study presented today at the American College of Cardiology's Innovation in Intervention: i2 Summit in New Orleans, La. The use of these systems to treat carotid artery blockage has only been studied in limited clinical trials, prior to FDA approval, in the pivotal SECuRITY (Registry Study to Evaluate the Neuroshield Bare Wire Cerebral Protection System and X-Act Stent in Patients at High Risk for Carotid Endarterectomy, 2004) study. Innovation in Intervention: i2 Summit is an annual meeting for practicing cardiovascular interventionalists sponsored by the American College of Cardiology in partnership with the Society for Cardiovascular Angiography and Interventions.



During carotid artery stenting, a small catheter tube is threaded into the artery and a stent is inserted and expanded inside the artery to increase blood flow in areas blocked by arterial build-up. While the stent is being placed, either arterial plaque or a blood clot could dislodge and cause serious complications. Embolic protection devices help capture and remove the debris created during arterial procedures through the use of a filter trap.



The current study, known as the EXACT study (Emboshield™ and Xact® Post Approval Carotid Stent Trial), tracked the progress of 1,500 patients in community hospitals who received carotid stent and/or embolic protection device treatments over the course of 30 days. Arterial pre-dialation (enlargement/widening of the arteries prior to stenting), symptomatic status and age acted as independent factors for death, stroke or peri-procedural complications, but only 4.5 percent of patients in the EXACT study suffered from peri-procedural complications, compared to 7.5 percent in the SECuRITY study.



"The EXACT results demonstrate that community hospital physicians with appropriate experience levels and device training can provide exemplary outcomes for patients in need of carotid stenting, and that results of stenting appear to be improving with greater experience," said William Gray, M.D., Director of Endovascular Services, Associate Professor of Medicine, Columbia University and lead author of the study. "Post-approval studies like EXACT are very important because they provide an opportunity to assess how technology can transfer to a new group of physicians, identify unforeseen equipment issues, and evaluate treatment outcomes not identified in restricted clinical trial settings."







Dr. Gray will present the results of the "EXACT 1500 Registry: Report of U.S. Multi Center Experience in Carotid Stenting in High Surgical Risk Patients" study on Monday, March 26 at 11:15 a.m. in room La Nouvelle Orleans C.



The American College of Cardiology (acc/) represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.07 and the i2 Summit is the largest cardiovascular meeting, bringing together cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.



Contact: Leslie Humbel

American College of Cardiology

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Cancer Drug Reformulation Featured In Prestigious Journal

Dr. Yuri Lvov, a professor of chemistry and T. Pipes endowed chair in micro and nanosystems at Louisiana Tech University, and Anshul Agarwal, a Louisiana Tech doctoral candidate in biomedical engineering feature their cancer drug reformulation work in the most recent issue of Pharma Focus Asia, one of the largest and most respected pharmaceutical science journals in the world.



"This is the largest Asian pharmacological journal and is turned to by millions of people working in the medical industry," says Lvov.



Lvov and Agarwal also share the cover of Pharma Focus Asia with some of the world's leading nanotechnology experts including Dr. George Whitesides of Harvard University, one of the top nanotechnology researchers in the U.S, who was also featured in this issue.



"The recognition that Dr. Lvov has received through this cover story confirms the world-wide leadership position that his research, his colleagues, and Louisiana Tech University holds," says Dr. Stan Napper, dean of Louisiana Tech's College of Engineering and Science.



Working from Louisiana Tech's Institute for Micromanufacturing, Lvov and Agarwal collaborated with pharmaceutical researchers from Northeastern University in Boston on an article titled "Sonication-Assisted Nanoencapsulation." The article looks at nanoencapsulation of low soluble cancer drugs and presents an innovative approach for adjusting drug release rates and attaching antibodies at the outer shell layers for targeted drug delivery.



"We may be able to drastically increase the efficiency of existing low-soluble cancer drugs by way of their nanoparticle formulation," says Lvov. "We are working with several other institutions around the country that are currently in the process of testing our new drug formulation."



"The application of his approach to nanoassembly into clinical drug delivery will enable further improvements in cancer therapy that may reduce some of the traumatic impact of current methods," states Napper.



Pharma Focus Asia is not the first publication to recognize Lvov's pioneering work in nanoencapsulation and drug reformulation. He has had over 160 papers on the topic published in peer-reviewed journals and, last November, was named the 2007 Innovator of the Year by Small Times Magazine for his work in this area.



But Lvov is quick to point out that he is not alone in this endeavor.



"This is not singular research. Drs. Mark DeCoster, David Mills, Patrick O'Neal and many Ph.D. students at the Institute for Micromanufacturing are diligently working on different parts of our drug nanoencapsulation program."



"Dr. Lvov's accomplishments contribute greatly to Louisiana Tech's international stature in the nanotechnology field," says Dr. Leslie Guice, vice president for research and development at Louisiana Tech. "He is highly respected among the research community and has built strong collaborations with top-notch researchers nationally and internationally."
















In addition to the medical benefits of this research, there could also be a significant economic benefit for northern Louisiana.



"Nanoencapsulation research is of significant interest to pharmaceutical companies," explains Guice. "This could play an important role in helping us attract some of these companies to Louisiana."



"We (Louisiana Tech) are not making a new drug," explains Lvov. "But just as important, we are the engineers working in nanotechnology to make new, more efficient formulations for existing drugs."



The strength and success of this program will continue to be built upon the collaboration of Louisiana Tech researchers with those of other institutions.



"We hope that the partnerships Dr. Lvov has developed with other institutions will continue to produce significant advances in medicine and in basic science," says Napper.



Lvov believes there is another important benefit of his research and the national and international publicity it is receiving.



"This exposure allows other people, domestic and abroad, to see that some of the best medical nanotechnology research programs in the country are located here at Louisiana Tech University."







Louisiana Tech University is home to the Institute for Micromanufacturing (IfM). The IfM has been conducting leading-edge research and development efforts in micro- and nanosystems since its inception over fifteen years ago. More than 50 faculty and staff are involved in the Institute's research programs. The IfM supports several interdisciplinary graduate and undergraduate degrees. Louisiana Tech has been ranked by Small Times as one of the national leaders in micro/nano education, research and commercialization.

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PPD Dermatology To Present At Second Annual Boston Biotech R&D Conference

PPD, Inc. (NASDAQ:PPDI) announced Sandra Luikenhuis, Ph.D., executive director of PPD® Dermatology, will present at the 2009 Boston Biotech R&D Conference in Boston, Mass., where she will introduce PPD Dermatology and discuss how the team is developing novel, science-based dermatologic therapies using a unique portfolio of in vitro assay systems and highly specialized expertise.


Dr. Luikenhuis's presentation is Oct. 27 at 11 a.m. ET at the Harvard Medical School. In her session, "Skin in the Game," she will discuss PPD Dermatology's approach to evaluating the safety and efficacy of novel compounds originally intended for systemic, nondermatological therapies to investigate their potential as topical treatments for dermatological conditions. The presentation will elaborate on the unique advantages of accessing PPD's compound partnering resources to drive clinical development of a lead compound through Phase II.


"There are few novel dermatologic products currently being developed to treat skin diseases effectively," said Dr. Luikenhuis. "This conference provides an excellent forum to exchange information on cutting-edge research and development programs with leading biopharmaceutical companies in the Boston area."


The conference joins prominent leaders from top academic institutions who have been influential in establishing the strong Boston biotech community with executives from several of the area's most aspiring biopharmaceutical companies, as well as leaders from the venture capital community and equity markets.


PPD formed PPD Dermatology earlier this year, following its acquisition of Magen BioSciences. The acquisition expanded PPD's compound partnering program into dermatology. PPD gained a pipeline of compounds through Magen's exclusive license to develop and commercialize preclinical compounds discovered by Eli Lilly & Co. for dermatologic therapeutics initially in the indications of psoriasis, atopic dermatitis and acne.


Source

PPD

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