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NeurogesX Applies For Approval Of Qutenza For HIV-Related Neuropathy Pain – Biopharmaceutical company NeurogesX has filed an application with the U.S. Food and Drug Administration (FDA) for approval of Qutenza to be used for treating pain associated with HIV-related neuropathy, a condition that causes pain, numbness, burning, or tingling in the extremities. Qutenza is a capsaicin patch that is placed on the skin for 30 minutes. It is currently approved for treatment of nerve pain due to shingles. NeurogesX has applied for a priority review of its application; if granted, the FDA would review the application within six months instead of the standard 10 months. For more information, please see the NeurogesX press release.

New HIV Vaccine Approach Shows Promise – Researchers from several U.S. medical centers have collaborated to create an HIV vaccine that strongly binds to and activates immune cells to destroy HIV. The vaccine was tested in monkeys and better stimulated their immune systems to create antibodies against HIV as compared to previous vaccine methods. Antibodies recognize bacteria and viruses and signal for the immune system to destroy the infectious agents. For more information, see the study in PLoS Pathogens or the Duke University Medical Center press release.

Texas HIV/AIDS Programs Face Significant Cuts In Federal Funding – As in many other states, federal funds for HIV care through the Ryan White Care Act have been cut and delayed in Texas. As a result, AIDS Resources of Rural Texas has closed, sending its clients to other North Texas HIV/AIDS organizations, which are also facing the same funding issues. Also due to funding problems, the AIDS Outreach Center in Fort Worth has had to reduce its number of case workers and scale back its food pantry. So far, there is no indication that the U.S. government will increase funding for agencies that help clients displaced by the closure. For more information, please see the related article in the Fort Worth Star-Telegram.

Theratechnologies Applies For Approval Of Egrifta In Argentina And Brazil – Theratechnologies, via an affiliate of its partner Sanofi, has applied for marketing approval of Egrifta (tesamorelin) in Argentina and Brazil. If approved, Egrifta will be the first drug in these countries to treat lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Based on average approval times, a decision would be expected in early 2012 in Argentina and late 2012 in Brazil. Egrifta was approved in the U.S. in November of last year, and Theratechnologies’ partners have since applied for approval in Europe, Israel, and Canada. For more information, please see the Theratechnologies press releases for Argentina and Brazil.

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IAS 2011 Conference Begins July 17 In Rome – The sixth International AIDS Society (IAS) conference will take place in Rome July 17 to 20. The conference, which is held every two years, is the one of the largest worldwide on HIV and AIDS. Topics will include new treatments and treatment possibilities for HIV, research and management of side effects and complications of HIV and antiretroviral therapy, and progress toward a cure. Conference organizers expect around 5,000 attendees. The AIDS Beacon will be providing coverage of conference results. For more information, please see the IAS 2011 conference website.

NIAID Makes Five Year, Multi-Million Dollar Grants Toward HIV Cure Research – The National Institute of Allergy and Infectious Diseases (NIAID) announced today that it has granted more than $14 million per year for up to five years toward research for a cure for HIV. The new grants, part of the Martin Delaney Collaboratory of funding toward an HIV cure, focus on studying and eliminating reservoirs of latent HIV (HIV that lies dormant during antiretroviral therapy until treatment is stopped). Recipients include the Fred Hutchinson Cancer Research Center, the University of North Carolina at Chapel Hill, the University of California, San Francisco, and the Vaccine & Gene Therapy Institute of Florida. For more information please see the NIAID press release.

Theratechnologies Applies For Marketing Approval Of Egrifta In Israel – Theratechnologies, via its partner Sanofi, has applied for marketing approval of Egrifta (tesamorelin) in Israel. If approved, Egrifta will be the first drug in Israel to treat lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Based on average approval times in Israel, a decision would be expected in mid-2013. Egrifta was approved in the U.S. in November of last year, and Theratechnologies’ partners have since applied for approval in Europe and Canada. For more information, please see the Theratechnologies press release.

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Washington, D.C. Still Has The Highest Rate Of HIV And AIDS In The U.S. – A report released last week by the District of Columbia Department of Health states that D.C. still has the highest rate of HIV in the country, with more than 3 percent of the population over the age of 12 testing positive. The report does note that the number of new cases reported has dropped almost 50 percent in the last two years, but health officials stated that part of the drop may be due to a newer, more accurate method for counting new cases. The disease continues to affect primarily African Americans and adults aged 30 to 59. For more information, please see the District of Columbia Annual Report 2010 or the Washington Post article.

Theratechnologies Applies For Approval Of Egrifta In Canada – Theratechnologies has applied for approval of Egrifta (tesamorelin) from the Therapeutic Products Directorate of Health Canada. If approved, Egrifta will be the first drug in Canada to treat lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Based on average approval times for Health Canada, a decision would be expected late next year. Theratechnologies applied for approval of Egrifta in Europe earlier this month via its partner Ferrer Internacional S.A., and the drug was approved in the U.S. in November of last year. For more information, please see the Theratechnologies press release.

June 27 Marks National HIV Testing Day – This year, June 27 will mark the 17th annual National HIV Testing Day. The day is organized by the National Association of People With AIDS (NAPWA), and its purpose is to publicize and promote regular HIV testing, particularly in at-risk populations such as African Americans and men who have sex with men. Communities and health centers will be offering HIV testing nationwide, in many cases free of charge. For more information or to find a local testing center, please see NAPWA’s National HIV Testing Day website.

Salix Pharmaceuticals Recruiting HIV-Positive Participants For Phase 3 Trial Of Diarrhea Drug – Salix Pharmaceuticals, a small pharmaceutical company based in North Carolina, is currently recruiting HIV-positive participants for a Phase 3 clinical trial of its investigational anti-diarrhea drug crofelemer. Participants must be on antiretroviral therapy and have had HIV-associated diarrhea for at least four weeks. Crofelemer successfully completed a Phase 3 clinical trial in people with HIV in November of last year in which three dosages (125 mg, 250 mg, and 500 mg daily) were tested; this new trial will test the safety and tolerability of a 125 mg dose twice daily. Salix is currently recruiting participants at locations in Arizona, Arkansas, California, Florida, and Georgia and expects to add additional locations at a later date. For more information, please see the U.S. Clinical Trials Registry.

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June 8 Marks National Caribbean-American HIV/AIDS Awareness Day – This Wednesday is the sixth annual National Caribbean-American HIV/AIDS Awareness Day. The purpose of the day is to raise awareness of HIV and AIDS in the Caribbean-American community and encourage HIV testing, education about the virus, and treatment for those who are HIV positive. Events will be held in Chicago, New York City, and other major cities with large Caribbean-American populations. For more information, please see the National Caribbean-American HIV/AIDS Awareness Day website.

Smithsonian Opens Exhibit On History Of HIV And AIDS – The National Museum of American History, one of the Smithsonian museums, has opened a special exhibit on HIV and AIDS to mark the 30th anniversary of HIV in the U.S. Entitled “HIV and AIDS Thirty Years Ago,” the exhibit discusses the history of the epidemic in the nation and worldwide and its effects on individuals and society. The exhibit also includes a website on the history of HIV and AIDS. For more information, please see the National Museum of American History press release or the exhibit website.

Emory University Creates Online Map Of HIV/AIDS In The U.S. – The Rollins School of Public Health at Emory University has created an interactive, online map of HIV and AIDS in the U.S. The map, called AIDSVu, includes information on HIV rates by zip code for most of the country and highlights the areas of greatest prevalence – primarily the Northeast, South, and Southwest. Viewers can also see HIV rates by gender, race/ethnicity, and age group. For more information, please see the Emory University press release or the AIDSVu website.

Theratechnologies Applies For Marketing Approval Of Egrifta In Europe – Theratechnologies, via its partner Ferrer Internacional S.A., has applied for marketing approval of Egrifta (tesamorelin) from the European Medicines Agency (EMA). If approved, Egrifta will be the first drug in Europe to treat lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Based on average approval times for the EMA, a decision would be expected mid to late next year. Egrifta was approved in the U.S. in November of last year. Ferrer has licensed the right to market Egrifta in Europe and is responsible for all required regulatory activity associated with the approval. For more information, please see the Theratechnologies press release.

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Today Is National Black HIV/AIDS Awareness Day – Today is National Black HIV/AIDS Awareness Day, a day created to memorialize African Americans lost to the pandemic as well as to raise awareness of the impact of HIV and AIDS on the black community. According to a recent report by the U.S. Centers for Disease Control and Prevention, African Americans made up half of new HIV diagnoses from 2005 to 2008, despite making up only 14 percent of the population. The theme of this year’s HIV/AIDS Awareness Day is “It Takes a Village to Fight HIV/AIDS.” The day will include awareness and testing efforts nationwide. In addition, the National Institute for Allergy and Infectious Diseases (NIAID) is urging African Americans to participate in clinical trials aimed at improving HIV prevention efforts in black communities. For more information or to find local events, please see the National Black HIV/AIDS Awareness Day website. For more information on clinical trials, please see the NIAID website.

Kaletra Added To FDA Side Effects Watch List For Potential Safety Problems In Newborns – Kaletra (lopinavir/ritonavir) oral solution has been added to a U.S. Food and Drug Administration (FDA) drug safety watch list due to potentially serious side effects in newborns. Kaletra’s inclusion on the watch list indicates that the FDA is concerned about a potential safety issue but does not have definitive evidence that the drug is actually causing harm. The FDA will continue to monitor reported side effects for Kaletra in newborns. The FDA states that the drug’s inclusion on the watch list does not mean that patients should discontinue Kaletra, but they should contact their physicians if they have concerns. Side effects can be reported to the Adverse Event Reporting System. For more information, please see the FDA website.

Struggling Florida ADAP Receives Assistance From Pharmaceutical Companies – The Florida Department of Health announced last week that it will receive temporary assistance from pharmaceutical companies to keep its struggling AIDS Drug Assistance Program (ADAP) running. ADAPs provide HIV drugs to low-income people with HIV and AIDS. The companies will provide free HIV drugs to 6,500 people in Florida’s ADAP through April, when the program will receive additional federal funding. The assistance will be provided through Welvista, a non-profit organization that helps the uninsured. Florida announced last month that unless it received financial assistance it would stop providing HIV drugs this month to members of its ADAP (see related AIDS Beacon news). For more information, please see the Sun Sentinel.

Theratechnologies Announces Licensing Agreement For Egrifta In Europe And Asia – Theratechnologies announced last week that it has reached a licensing agreement with Spanish pharmaceutical company Ferrer Internacional S.A. to market Egrifta (tesamorelin) in Europe, Russia, South Korea, Taiwan, and some central Asian countries. Egrifta is the first drug to treat lipodystrophy, abnormal fat distribution that is a side effect of certain anti-HIV medications. Under the agreement, Ferrer will be responsible for marketing and regulatory approval; Theratechnologies will manufacture Egrifta and is responsible for any additional research and development. Theratechnologies and Ferrer have not yet specified when Egrifta might be available in these countries. For more information, please see the Theratechnologies press release.