With federal funding from the Centers for Disease Control and Prevention, the Alabama
Department of Public Health announces a request for HIV/AIDS proposals from community
organizations and other entities.

The HIV/AIDS Division is seeking two types of proposals. First, the division is seeking sciencebased
proposals that have both proven prevention methods and a testing component.

Secondly, in addition to the science-based proposals, two proposals will also be accepted
covering treatment adherence and wellness for persons coping with chronic diseases. HIV
infection will be a priority in addition to other chronic diseases such as heart disease and
diabetes.

Jane Cheeks, director of the HIV/AIDS Division, stated, “The purpose of this acquisition is to
support prevention activities that reduce risk behaviors associated with the transmission of HIV
and to promote treatment adherence and healthy lifestyles.”

Eligibility will be based on a documented 501(c) (3) nonprofit or state government agency status
and service experience. The deadline to send a letter of intent to submit a proposal is Nov. 16,
2009. The deadline to submit a proposal is Dec. 2, 2009.

Source
Alabama Department of Public Health

Argos Therapeutics announced two presentations at the AIDS Vaccine 2009 conference, detailing positive viral load, immune response and safety data from an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate. AGS-004 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden. The presentations contained important results, including a favorable safety profile for AGS-004, the ability to induce partial to complete viral load control in the absence of antiretroviral therapy (ART) during a 12-week structured treatment interruption (STI), and a potent and diverse immune response to AGS-004 treatment. These AGS-004 results are unprecedented for an immunotherapeutic candidate in HIV and, if confirmed in an upcoming randomized study, could lead to a new treatment paradigm for HIV.

“The Arcelis approach to immunotherapy has broad potential as a new therapeutic strategy to combat HIV,” said Jean-Pierre Routy, M.D., from McGill University Health Centre in Montreal. “The level of viral load control in response to AGS-004 has been unexpectedly strong compared to what has been reported for other immunotherapies tested in similar patient populations. Additionally, because this approach uses patient-specific HIV antigens, it may overcome the extreme genetic heterogeneity of HIV from patient to patient, which has been one of the reasons for the failure of prior HIV immunotherapies.”

In an oral presentation, Dr. Routy, principal investigator of the ongoing Phase 2a trial, discussed data assessing the safety and impact of AGS-004 in controlling viral load during a 12-week STI from ART. Patients enrolled in the trial had pre-ART viral load levels ranging between 10,000-500,000 copies/mL. Data were presented for 16 patients that had successfully completed the STI. After the three month treatment break from ART, 13 of 16 patients had a lower viral load compared to their pre-ART levels, with a mean reduction of greater than 1 Log, corresponding to a greater than 80% reduction from pre-ART levels. AGS-004 also exhibited a favorable side-effect and safety profile, with no reports of autoimmunity or AIDS-defining events during the STI, and no treatment-related serious adverse events reported.

Charles Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos Therapeutics, commented, “These data demonstrate that AGS-004 may make a significant impact on pre-ART viral load levels during an STI, and that it is potentially able to keep patients safely off of ART for at least three months. Most of the patients in this trial were chronically infected, and did not have a genetic predisposition to viral control. Therefore, the large reduction in viral load from pre-ART is a very promising outcome. These data provide strong support for one of the main therapeutic objectives of AGS-004, that it could potentially offer patients partial or complete independence from ART, thereby addressing the side effects, resistance, and compliance issues associated with ART and improving patients’ quality of life.”

In a poster session, Bader Yassine-Diab, Ph.D., from the National Immunomonitoring Laboratory (NIML) at the University of Montreal Research Center, presented additional data supporting patients’ immune response to the autologous HIV antigens used in AGS-004 - Gag, Nef, Rev, and Vpr - following STI. Researchers analyzed patients’ anti-HIV-specific immune responses by evaluating the proliferation and the functionality of CD8+ and CD4+ T cells stimulated with these autologous HIV antigens. Preliminary results indicated an increase in HIV-specific CD8+ T-lymphocyte polyfunctional populations following immunotherapy with AGS-004, which was accentuated after the STI from ART.

“Although still preliminary, we are impressed with the diversity and strength of the immune responses observed so far. Importantly, the immune responses were composed of the same types of T cells observed in long-term non-progressors, which are individuals who are infected with HIV, but whose infection does not rapidly progress to AIDS,” said Rafick Sekaly, Ph.D., Scientific Director of the NIML.

Based on these positive data from the current Phase 2a study, Argos is planning on initiating a Phase 2b trial in the first half of 2010. The majority of the costs of this next trial will be funded by the National Institutes of Health, as part of a $21 million contract that Argos was awarded in 2006.

The first abstract, titled, “Safety and Viral Load Changes in HIV-1 Infected Subjects Treated with Autologous Dendritic Immune Therapy Following ART Discontinuation,” was authored by J.P. Routy, M.R. Boulassel, M.R. Loutty, S. Vezina, C. Tremblay, J. Angel, J. Gill, J. Baril, F. Smaill, R. Jain, D. Healey, I. Tcherepanova, C. Nicolette, and R. Sekaly.

The second abstract, titled, “Immunogenicity of an Autologous Dendritic Cell Anti-HIV Therapy in HIV-1 Infected Individuals,” was authored by B. Yassine-Diab, Z. Coutsinos, C. Landry, D. Gagnon, D. Sauve, C. Hebert-Benoit, V. Hebert, M.R. Boulassel, J.P. Routy, R. Jain, I. Tcherepanova, D. Healey, C. Nicolette, and R. Sekaly.

This work was funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. N01-AI-60019.

About the Arcelis™ Technology

Arcelis is Argos’ proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies for HIV, other infectious diseases, and cancer. This platform is based on optimizing a patient’s own (autologous) dendritic cells to trigger a pathogen- or tumor-specific immune response. To address the challenge of the unique genetic profile of each patient’s disease and the genetic mutations of that disease, Argos loads the autologous dendritic cells with a sample of messenger RNA (”mRNA”) isolated from their disease. Through this process, dendritic cells can potentially prime immune responses to the entire antigenic repertoire, resulting in an immunotherapeutic that is customized to the patient’s specific disease. The development of Arcelis is part of Argos’ broad collaboration with Kyowa Hakko Kirin Co., Ltd.

Source
Argos Therapeutics, Inc.

Medical providers on the front lines of HIV care applaud the U.S. Congress for extending the Ryan White HIV/AIDS Program, helping to ensure that more than half a million low-income, uninsured, or underinsured people living with HIV/AIDS have access to lifesaving care. The HIV Medicine Association (HIVMA) and the Ryan White Medical Providers Coalition (RWMPC) are pleased with Congress’ four-year extension of this critical safety net and urge President Obama to quickly sign this important legislation.

“As HIV clinicians and researchers, many of whom have been providing HIV care since the mid-1980s, it is gratifying to see so many of our patients benefiting from the current treatment approaches, especially compared with the heartbreaking patient outcomes we saw earlier in the pandemic,” said Michael S. Saag, MD, FIDSA, HIVMA chair-elect. “These remarkable outcomes simply would not be possible without support from the Ryan White Program. We thank Congress for extending this vital program for four years, and we call on the president to quickly sign this legislation to ensure that our patients have access to the care they need.”

The Ryan White HIV/AIDS Treatment Extension Act of 2009 would authorize a 5 percent annual increase in funding for the program, which funds medical care and other services for individuals who otherwise would likely go without care. With more than 50,000 new cases of HIV infection in this country every year, HIVMA and RWMPC urge lawmakers to increase Ryan White funding annually by at least this authorized amount, if not more, during the next four years to help address the growing need for treatment.

“Even before the current recession hit, many HIV clinics and providers were struggling to maintain the level of services that have made them so effective at delivering lifesaving care to their patients,” said Kathleen Clanon, MD, RWMPC co-chair. “As the strains on our health care system grow, HIV caseloads rise, and state HIV programs are threatened by additional budget cuts, adequate funding increases for the Ryan White Program will be critical to ensuring that patients continue to receive the multidisciplinary care they need, even when they cannot afford it.”

With lawmakers finalizing health care reform legislation, the extension of the Ryan White Program is vital to ensuring there are no gaps in coverage or access to care for those living with HIV/AIDS as reforms are implemented nationwide. Additionally, health reform offers a unique opportunity to increase support for the medical home model of care provided by Ryan White programs and to integrate these programs into the reformed health care system.

“Ryan White programs, at HIV clinics around the country, are models for delivering high-quality, cost-effective care to people with chronic conditions,” said J. Kevin Carmichael, MD, RWMPC co-chair. “This patient-centered approach, known as the medical home model, treats the whole person by providing a range of services that HIV/AIDS patients need to stay healthy. It’s critical to keeping people with HIV in treatment and addressing their complex health care needs.”

Treatment advances have transformed HIV infection from a death sentence to a chronic condition for many patients, but only for those with ongoing access to medical care. “Funding through Ryan White has allowed HIV clinics across the country to develop model programs to deliver this comprehensive and coordinated care for more than a decade,” said Dr. Saag. “We could not do the work we do every day without this support, and this four-year extension will help ensure that it continues.”

Source:
John Heys

Infectious Diseases Society of America