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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