Expansion of HIV/AIDS Vaccine Program Announced by GeoVax Labs, Inc.

/PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), announced today that it is expanding its preventative HIV/AIDS vaccine development effort in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN). Specifically, the HVTN plans to clinically test a novel vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with inactivated HIV proteins. The novel vaccine consists of a recombinant DNA vaccine co-expressing human GM-CSF and non-infectious HIV virus-like-particles. The DNA vaccine is used to prime immune responses that are subsequently boosted by vaccination with a recombinant modified vaccinia Ankara (MVA) vectored vaccine. The MVA expresses the HIV virus-like-particles, but does not express GM-CSF. The regimen builds on the GeoVax DNA/MVA vaccine that is currently in Phase 2a clinical testing through the HVTN.

GM-CSF is a cytokine (growth stimulating protein) that serves to expand and mature cells that initiate immune responses and has undergone extensive testing in humans for cancer vaccines. The GM-CSF-adjuvanted vaccine was added to GeoVax's portfolio because of the outstanding ability of the simian prototype vaccine to induce immune responses that prevented simian immunodeficiency virus (SIV) infection. In nonhuman primates, the GM-CSF enhanced vaccine achieved protection against SIV in 70% of the animals. Protection was measured against 12 weekly rectal challenges using a dose of SIV which is estimated to be 30 to 300 times higher than the typical exposure dose of HIV in mucosal transmission in humans.

"For years, the HIV vaccine field has been working with vaccines that elicited immune responses that primarily controlled immunodeficiency virus challenges in infected animals, but did not actually prevent infections. The ultimate goal is to prevent infections. The co-expression of GM-CSF with the SIV proteins is a vaccine design that appears to be a large step towards reaching this goal," said Dr. Harriet Robinson, Chief Scientific Officer at GeoVax. "In our trials in nonhuman primates, GM-CSF enhanced the quality of the SIV-specific antibody response. Antibody is present in blood and tissues and has the potential of blocking SIV before it infects cells. The GM-CSF-adjuvanted vaccine induced the production of antibodies characterized with increased tightness of antibody binding. The tightness of antibody binding, known as avidity, can be expressed as an index. Animals with indices above 40 were protected from infection, whereas animals with lower indices were infected with the number of challenges to infection correlating with their index."

"We are very pleased that the HVTN will be conducting trial HVTN 094 of our GM-CSF adjuvanted vaccine product, which we expect will begin late this year," said Dr. Robert McNally, CEO of GeoVax. "The HVTN, funded by the NIAID, is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. We are looking forward to working with an excellent team of HVTN trial investigators."

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ViiV Healthcare Awards Southern Initiative Grants to Reduce HIV Disparities Among African Americans and Latinos

/PRNewswire/ -- ViiV Healthcare today announced the grant awardees of the Positive Action Southern Initiative, focused on supporting African American and Latino populations in Alabama, Georgia, Louisiana, and Mississippi to help high-risk HIV/AIDS individuals and provide linkages to HIV/AIDS care and treatment adherence.

"The Positive Action Southern Initiative awards are being made at a critical time in the national fight against HIV. These funds are nothing short of life-saving. Community organizations are facing tremendous pressure to do more with less in this economic climate and the demands continue to grow, especially among African American and Latino communities in Southern states," stated A. Cornelius Baker, Senior Policy Advisor of the National Black Gay Men's Advocacy Coalition. "I am excited that ViiV is supporting such important initiatives that address disparities in HIV and support the goals of the National HIV/AIDS Strategy."

In the U.S., 1.1 million people are living with HIV/AIDS(i) and African Americans and Latinos account for a disproportionate share of new HIV infections (62 percent). In 2007, the Southern United States accounted for almost half (46 percent) of new AIDS cases and has the greatest number of people estimated to be living with AIDS(i).

The Southern Initiative is part of ViiV Healthcare's Positive Action, a collaborative, community-focused program designed to address gaps in services or programs that support care and treatment adherence among individuals living with HIV/AIDS. ViiV Healthcare has committed $850,000 this year to support Positive Action Community Grants in the U.S. and $500,000 over the next two years to support the Southern Initiative grantees. ViiV Healthcare is hosting the grant recipients at this week's United States Conference on AIDS, where they will enable the development of a Regional HIV Network to share best practices and resources to advance the fight against HIV.

ViiV Healthcare has selected a total of seven organizations to receive grants over the next two years to support their programs specifically focused on reducing disparities in HIV/AIDS linkages to care and treatment among African American and Latinos in Alabama, Georgia, Louisiana, and Mississippi. The following organizations were selected as grant awardees:

-- Aid to Inmate Moms, based in Montgomery, AL, will continue its
collaboration with local AIDS Service Organizations to support
HIV-positive incarcerated women with critical counseling services.
-- Atlanta Harm Reduction Coalition, based in Atlanta, GA, will provide
additional case management services for HIV-positive individuals who
are re-entering the community from the state's jails and prisons.
-- Family Service of Greater Baton Rouge, based in Baton Rouge, LA, will
expand its Corrections Referral and Case Management program to serve
more HIV-positive individuals exiting the corrections system and to
successfully connect them with quality care.
-- Grace House in Jackson, MS, will expand its CLEAR (Choosing Life:
Empowerment, Action, Results) program to serve more HIV-positive
clients and provide services aimed at improving treatment adherence,
cognitive behavior, and prevention activities.
-- Positive Impact, based in Atlanta, GA, will provide additional
intensive case management services for HIV-positive Latino individuals
and HIV-positive African American women.
-- Southwest Louisiana AIDS Council based in Lake Charles, LA, will
expand its medical systems navigation program, FAST (Find, Assess,
Stabilize, and Treat), to serve additional newly-diagnosed persons,
previously incarcerated persons, and those who have not successfully
remained in care.
-- Union Mission's J.C. Lewis Primary Health Care Center, based in
Savannah, GA, will enhance its Healthy Living education and adherence
program for homeless and low-income persons living with HIV/AIDS.



"ViiV Healthcare received a great response from grassroots organizations in the South demonstrating the need is great. The awardees' proposed programs are unique and provide promise towards alleviating HIV in the United States among communities most impacted by the disease. ViiV Healthcare puts the interests of those affected by HIV at the center of everything we do. We are honored to support communities through these grants. It is our hope the initiatives will positively impact those areas in critical need of HIV/AIDS resources," said Bill Collier, Head of North America, ViiV Healthcare.

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Are HERVs an Answer to AIDS Mysteries?

/PRNewswire/ -- Why is it so hard to isolate and purify human immunodeficiency virus (HIV)? Why has no one been able to see, by electron microscopy, a single HIV particle in the blood of AIDS patients, even those who have a "high viral load"? Why does HIV seem to mutate with startling rapidity? AIDS researchers have not been able to come up with answers to these questions.

HERVs--human endogenous retroviruses--might provide explanations that have been overlooked for 20 years, writes Professor Etienne de Harven, M.D., in the fall 2010 issue of the Journal of American Physicians and Surgeons. HERVs are present in all of us, and fragments of their DNA may be confused with HIV in the polymerase chain reaction (PCR) tests used to estimate viral load.

The beautiful photographs of HIV published in both lay and scientific journals are embellished with special effects from computerized image reconstruction. Since they come from cell cultures, which are likely to be contaminated, the particles may be "elegant artifacts" rather than the exogenous virus--a virus of external origin--believed to cause AIDS, de Harven states.

About 8 percent of the human genome consists of sequences incorporated from retroviruses. When cells break down, DNA fragments are released into the circulation--including these viral sequences. Patients with clinical AIDS carry a large spectrum of infectious diseases, so a high level of circulating DNA is expected.

While "AIDS Rethinkers" may challenge the role of HIV in AIDS, or even its existence, they are obligated to explain the observations of clinicians and researchers. HERVs are, at a minimum, a confounding variable that needs to be investigated, de Harven notes.

Puzzles involving the interpretation of diagnostic tests for HIV, the epidemiology and transmission patterns of AIDS, and strategies for prevention and treatment cannot be solved without broadening AIDS research beyond the narrow confines accepted by the "Orthodoxers," de Harven believes. Alternate hypotheses need to be objectively assessed, and conclusions must be based on scientific evidence rather than consensus.

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Old Drug Holds Promise Against Opportunistic Lung Bug

/PRNewswire/ -- A drug to treat inflammation plays a surprising role reducing the level of infection caused by an opportunistic bug that is deadly for AIDS and cancer patients and others with weakened immune systems.

The drug, sulfasalazine, spurs the body to get rid of the fungal evaders by enhancing the body's ability to chew them up instead of leaving the debris to litter the lungs, where it would continue to provoke an onslaught of harmful inflammation.

Besides opening a new avenue for research on Pneumocystis pneumonia or PCP, caused by the fungus Pneumocystis jirovecii, the work with mice also offers the possibility of manipulating immune cells called macrophages to improve treatment of infections.

The findings by scientists at the University of Rochester Medical Center were published August 19 in the journal PLoS Pathogens.

During a bout with Pneumocystis, the lungs become a battlefield, where the body pits an array of impressive forces against marauding microbes. But even when the body gets the upper hand, the damage is tremendous. Immune cells like neutrophils and macrophages can flood the lungs, literally suffocating the patient. And when the debris from dead microbes fills the lungs, more and more immune cells are called in to clean up the area, making matters worse. It becomes harder and harder to breathe.

"Many people assume that once the microbe is dead, patients usually start to feel better immediately. But with Pneumocystis, patients do not always undergo a rapid clinical improvement following antibiotic treatment. Even though the bug has been killed, the debris that is left in the lungs continues to promote inflammation," said corresponding author Terry Wright, Ph.D., an infectious disease specialist and associate professor of Microbiology and Immunology and of Pediatrics.

Pneumocystis is a common bug that infects nearly everyone at some point; the authors say that more than 80 percent of children have been infected by the age of 2. Most people shake off the infection without consequence, but for people with cancer, AIDS, or other diseases that compromise their immune system, the infection can be deadly. Usually there are few signs that the patient is sick until the infection is well established and the fungus is widespread in the lungs. Among cancer patients, mortality rates as high as 40 percent have been reported.

Since the body's immune response is central to how Pneumocystis kills patients, doctors use two different types of drugs in tandem to treat patients - an antibiotic to kill the bug, and steroids or another type of drug to reduce the consequent inflammation.

Central to the study were mice in which the disease progresses in a manner very similar to AIDS patients. The remarkable strides in AIDS therapy in recent years have come with a down side for many patients, thanks to Pneumocystis: When anti-retroviral therapy kicks in, a patient's immune system often becomes stronger very quickly - and if the fungus is present, the immune system attacks it vigorously, causing a potentially deadly form of pneumonia.

Wright's team looked at the effects in mice of sulfasalazine, an anti-inflammatory drug that has proven useful in treating conditions like Crohn's disease and rheumatoid arthritis. The team found that Pneumocystis-infected mice treated with sulfasalazine developed much less severe disease than untreated mice. The sulfasalazine-treated mice had better lung function, less weight loss, and were generally healthier than untreated animals.

While some of the benefit was due to the drug's anti-inflammatory properties and was expected, the result included a big surprise: The drug also spurs the body to remove the bug more aggressively by boosting the activity of immune cells called macrophages.

"This was unexpected," said first author Jing Wang, Ph.D., research assistant professor in Pediatrics. "Since we reduced the response of the immune system, you would think the mice would get sicker. But instead, the mice treated with sulfasalazine were healthier. At first we thought it was due solely to the anti-inflammatory activity of the compound, but it turns out that sulfasalazine actually results in a reduced fungal burden. The drug helps the body clear the infection.

"We initially thought we had done something wrong, and so we repeated the experiment again and again. Then, when new technology was developed, we were able to document that the body cleared the infection more readily with sulfasalazine," added Wang.

Scientists have long known that the body's immune T cells are central to the body's response to fight off the infection. The Rochester team showed that the body's T cells spur macrophages to attack the fungus - to engulf its particles and chew them up in a process known as phagocytosis.

While scientists have long suspected that role for macrophages, the Rochester team relied on a new technology to gather the first direct evidence of macrophages engulfing fungal particles. The scientists worked closely with Timothy Bushnell, Ph.D., and others at Rochester's Flow Cytometry Resources Core, investigating new ways to use lasers to capture images of molecular events. Bushnell's team ultimately connected the team with scientists at Amnis. Together the group developed a new way to capture macrophage phagocytosis in single cells from mice infected with Pneumocystis. The technology enabled the team to capture more than 40,000 such events, compared to just a handful when using conventional microscopy.

The team showed that as macrophage activity increased, the animals' health improved and levels of fungus decreased. For example, 17 days after infection, mice treated with sulfasalazine had nine times as many macrophages that had engulfed fungal particles compared to mice that had not been treated with the compound.

"This marks a new direction in which to look for new therapies to treat Pneumocystis as well as other inflammatory diseases. Identifying modulators that can increase or decrease the action of our immune system in a precise manner is a growing area of research," said Wright. Recently researchers have come to realize that there are different kinds of macrophages, and Wright noted that the type whose activity is trigged by sulfasalazine does not contribute to inflammation.

In addition to Wang and Wright, other authors include Francis Gigliotti, M.D., professor of Pediatrics and of Microbiology and Immunology, and also chief of Infectious Disease at Golisano Children's Hospital; Samir Bhagwat, Ph.D., research assistant professor of Pediatrics; and Thaddeus George from the Amnis Corp. in Seattle. The work was funded by the National Heart Lung and Blood Institute and the Strong Children's Research Center.

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Abzyme Research Foundation Announces Promising HIV Vaccine Candidate

/PRNewswire/ -- The Abzyme Research Foundation announces today that Dr. Sudhir Paul, a scientist at University of Texas Houston Medical School, has identified an important immunological deficiency in HIV-infected patients and has created a promising HIV vaccine candidate that rectifies the deficiency. The discoveries were presented on July 19th and 20th, 2010 at the XVII International AIDS Society Conference in Vienna, Austria.

The HIV vaccine candidate has been tested in mice and rabbits. It was effective in inducing the production of protective antibodies that stopped the HIV from infecting human blood cells in laboratory tests.

Dr. Paul and his colleagues discovered that HIV patients do not produce sufficient protective antibodies of a type called IgG that are capable of attacking the vulnerable CD4 binding site on the HIV. The virus binds to human host cells through this site to cause infection. The CD4 binding site is a small part of gp120, a protein found on the surface of HIV. Studies of mice injected with gp120 confirmed an insufficient IgG response to the CD4 binding site. Previous vaccine tests by other researchers used the gp120 protein itself without success in protecting against infection.

"Using an electron-seeking form of gp120, we triggered the production of the crucial IgG antibodies to the CD4 binding site in animals," said Dr. Paul. "We believe this method is the key to developing an HIV vaccine."

Dr. Paul's team has found that chemical stimulation of the immune system by electron-seeking (electrophilic) proteins is the central step for rectifying the defective antibody response to the CD4 binding site. Since the structure of the CD4 binding site is very similar in all HIV strains throughout the world, a globally effective HIV vaccine may be possible.

Lead E-VAC Candidate

The researchers have developed a synthetic electrophilic vaccine candidate, or E-VAC, which works by focusing the antibody response at the CD4 binding site. The E-VAC is a synthetic portion of gp120 that successfully mimics the shape of the CD4 binding site expressed by the HIV virus. Administration of E-VAC to animals induces antibodies with enzymatic activity, or abzymes. Unlike traditional antibodies that neutralize the target on a 1:1 basis, abzymes are significantly more efficacious because each abzyme molecule can neutralize thousands of target molecules.

E-VAC administered to mice and rabbits induced the production of blood-borne IgG antibodies that blocked the infection of human cells by genetically divergent HIV-1 strains from across the world.

"We are backing the research of Dr. Paul's team because his approach using abzymes shows enormous progress in creating an HIV vaccine," said Alan Kleiman, chairman of the board for the Abzyme Research Foundation. "Our foundation aims to drive discovery and innovation in the field of HIV research in hopes of one day eliminating the HIV/AIDS pandemic."

The lead E-VAC was developed from recent proof-of-concept studies that validated targeting of the CD4 binding site and chemical stimulation of the immune system as published recently by Dr. Paul's team in the journals AIDS and The Journal of Biological Chemistry. The work is being conducted at the University of Texas Houston Medical School and California Department of Public Health with support from the National Institutes of Health.

In addition to Dr. Paul, key contributors are Drs. Stephanie Planque, Yasuhiro Nishiyama and Carl Hanson. Dr. Planque is presenting the results at the Vienna AIDS Conference. Dr. Planque's paper was selected by International AIDS Society for the IAS/ANRS Young Scientist Award to be presented at the Conference.

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ARCA Launches First Therapeutic Trial with GeoVax Vaccine

PRNewswire-- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today The AIDS Research Consortium of Atlanta (ARCA) has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from GeoVax, Inc. Although the GeoVax vaccines are currently being studied for HIV prevention, this is the first study using the same products for treatment of persons who already have HIV infection. ARCA is the only site for this trial.

"ARCA is pleased to be conducting this important clinical trial," said Dr. Melanie Thompson, Principal Investigator for ARCA. "New approaches to HIV treatment are critically needed, and an effective therapeutic vaccine would be an important tool in our ongoing efforts to treat people with HIV infection. A vaccine that enhanced the body's ability to control HIV and delayed or decreased the dependence on anti-HIV drugs would be a major breakthrough for HIV treatment."

To be eligible for the study, persons should have had a negative HIV test followed by a positive test up to 6 months later, and they should have started drugs to fight HIV within 6 months of being diagnosed. The study will last up to 77 weeks. All patients will be followed closely for safety and for the ability of the vaccine to elicit protective immune responses in vaccinated participants. Patients will be compensated for their participation in the study. Only 10 to 12 persons will be selected to participate. Persons who believe they may qualify for the study should contact ARCA at vaccine@arcatlanta.org or 404-876-2317. ARCA is also interested in identifying possible candidates who fit the enrollment criteria but have not yet started anti-HIV drugs.

ARCA worked together with GeoVax to design the protocol for the Phase 1 clinical trial. The trial is based on the achievement of excellent post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.

About the AIDS Research Consortium of Atlanta

ARCA is a registered 501(c)(3) not-for-profit clinical research, testing, outreach and educational organization founded in 1988. ARCA works through a network of more than 50 physicians and 5 public health clinics to conduct clinical drug and vaccine trials and prevention research studies. 2 ARCA also provides patient and care-provider educational programs, free STD testing for men, and free, anonymous HIV testing when funds are available. More than 6000 Atlantans have learned their HIV status through ARCA's HIV testing program. ARCA has become one of the most respected and successful HIV/AIDS research facilities in the country over the past two decades by enrolling more than 2,000 metro Atlanta residents in more than 300 clinical drug trials that provide the latest investigational HIV/AIDS medications at no cost to them. ARCA has contributed key scientific information leading to the FDA approval of more than 27 individual and combination drugs now available for people with HIV/AIDS worldwide. ARCA was one of only three centers in the US that participated in a Centers for Disease Control and Prevention (CDC) study to test the safety of tenofovir, an existing HIV medicine, as a possible tool to prevent HIV infections. Over a 14 year period, ARCA enrolled more than 10.000 Atlantans with HIV infection in a CDC study to better understand HIV and AIDS. In all, more than 20,000 Atlantans have participated in ARCA studies and services. For more information, visit www.arcatlanta.org.

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Medicare Expands List of Covered Preventive Services to Include HIV Screening Tests

The Centers for Medicare & Medicaid Services (CMS) today announced its final decision to cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries
of any age who voluntarily request the service. The decision is effective immediately.

Under the recently passed Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS now has the flexibility of adding to Medicare's list of covered preventive services, if certain requirements are met. Prior to this law, Medicare could only cover additional preventive screening tests when Congress authorized it to do so.

"Today's decision marks an important milestone in the history of the Medicare program," said HHS Secretary Kathleen Sebelius. "Beginning with expanding coverage for HIV screening, we can now work proactively as a program to help keep Medicare beneficiaries healthy and take a more active role in evaluating the evidence for preventive services."

Under MIPPA, CMS can consider whether Medicare should cover preventive services that Congress has not already deemed as covered or non-covered by law. Among other requirements, the new services must have been "strongly recommended" or "recommended" by the U.S. Preventive Services Task Force. For instance, the Task Force graded HIV screening as "strongly recommended" for certain groups. More information about the Task Force is available online at
http://www.ahrq.gov/clinic/uspstfix.htm.

"Every adult should know their HIV status," said Dr. Howard K. Koh, HHS assistant secretary for health. "This decision by Medicare should help promote screening and save lives."

CMS uses the national coverage determination (NCD) process to make decisions on these types of preventive services. This process provides transparency about the evidence that CMS considers when making its decisions and allows opportunity for the public to comment on CMS'
proposals.

"Medicare's coverage of HIV screening tests is an important step forward in protecting beneficiaries from the potentially devastating and life-threatening complications of HIV and Acquired immunodeficiency Syndrome (AIDS)," said CMS Acting Administrator Charlene Frizzera.

AIDS is diagnosed when an HIV-infected person's immune system becomes severely compromised or a person becomes ill with an HIV-related infection. Of the more than one million estimated to have the HIV infection, the Centers for Disease Control and Prevention has estimated that about a quarter of them do not realize they are infected. Without treatment, AIDS develops within 8 to 10 years. While there is presently no cure for HIV, screening can help identify infected patients so that they can receive medical treatment that could help delay the onset of AIDS for years.

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FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR

The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people
infected with and affected by HIV/AIDS worldwide.

The PEPFAR program is a cooperative effort that involves the Food and Drug Administration (FDA) and other HHS agencies, the State Department's Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many other international partners.

"This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS," said HHS Secretary Kathleen Sebelius.

To date, more than 100 products have been assessed by the FDA and either fully or tentatively approved in association with the PEPFAR program. Of these, 29 have been new products and 71 have been generic copies of previously authorized antiretroviral products in the United States.
Twenty-two of these new products are new combinations or regimens that have not previously been authorized in the United States. In addition, there are seven new pediatric products considered innovative for patients in developing economies.

"As we recognize the 100th product authorized in this program, it is estimated that FDA's actions are allowing PEPFAR to spend $150 million more each year on patient access to care," FDA Commissioner Margaret A. Hamburg, M.D., told those attending an event marking the approval at the Pan American Health Organization (PAHO) headquarters in Washington, D.C.
"I look forward to developing and expanding FDA's international collaborations."

As of Sept. 30, 2008, the most recent figure available, PEPFAR supported life-saving antiretroviral treatment for more than 2.1 million men, women, and children living with HIV/AIDS. In fiscal year 2008, PEPFAR provided nearly $1.6 billion in support of treatment programs, including antiretroviral drugs and services.

"PEPFAR is committed to supporting partner countries to build and maintain sustainable procurement and supply chain systems," said U.S. Global AIDS Coordinator Eric Goosby.

Drug products used in PEPFAR receive a "tentative approval" and cannot be approved for marketing in the United States because of existing patents and marketing exclusivity. However, these products meet all the FDA's manufacturing quality, clinical safety, and efficacy requirements to produce them using the same standards as required for marketing in this country.

FDA performs all of its reviews of applications received in association with the PEPFAR on an expedited basis. After receiving approval or tentative approval from FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows FDA to share data from its evaluations with the WHO team in Geneva.

"Improving access to good quality medicinal products is a core objective of public health efforts and one with a direct and measurable impact on health," said Margaret Chan, M.D., director-general of WHO. The goal of PEPFAR is to work with host nations to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, PEPFAR will support training of at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.

"We need to urgently and actively implement strategies to promote greater affordability of both first and second line HIV/AIDS antiretrovirals," said Mirta Roses, M.D., director of PAHO, an
international public health agency that works to improve health and living standards in the Americas. "PEPFAR has made a tremendous difference in the health of disadvantaged people."

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Center for AIDS Research at Emory University to Serve as Local Host of AIDS Vaccine 2010

/PRNewswire/ -- The Global HIV Vaccine Enterprise (the Enterprise) today announced that the Center for AIDS Research at Emory University (CFAR) in Atlanta, Georgia will serve as Local Host of AIDS Vaccine 2010, the largest and most important global scientific conference focused on AIDS vaccine research. AIDS 2010 is to be held September 28 to October 1, 2010. This annual international conference brings together scientists, community advocates, funders, and policy makers from around the world to hear cutting edge scientific results, exchange new ideas, educate future leaders, and engage a diverse community of scientists in the quest for an HIV vaccine.

"The Global HIV Vaccine Enterprise is committed to accelerating the search for a safe and effective vaccine through scientific collaboration and global initiatives that bring together the world's best researchers, scientific organizations, advocates, funders, and policy makers for common purpose," said Alan Bernstein, Ph.D., executive director, Global HIV Vaccine Enterprise. "Our annual AIDS Vaccine conference is one such initiative and we look forward to collaborating with the Center for AIDS Research at Emory University to plan and implement the premier conference dedicated to HIV vaccine research."

AIDS Vaccine 2010 will feature daily plenary presentations by leading researchers, clinicians, and community advocates, and oral and poster presentations of hundreds of research papers addressing every aspect of HIV vaccine development and testing. The conference is expected to attract more than 1,000 researchers, clinicians, and community advocates from around the world to Atlanta.

Eric Hunter, Ph.D., Georgia Research Alliance eminent scholar and co-director, Center for AIDS Research at Emory University will chair AIDS Vaccine 2010 with support from the following co-chairs: James Curran, M.D., MPH, dean, Rollins School of Public Health and co-director, Center for AIDS Research, Emory University; Carlos del Rio, M.D., Hubert chair, department of Global Health, Rollins School of Public Health and co-director, Center for AIDS Research, Emory University; and Harriet Robinson, Ph.D., senior vice president of research and development, GeoVax, former director, division of Microbiology and Immunology, Yerkes National Primate Research Center, Emory University.

"The Center for AIDS Research at Emory University is pleased to host the AIDS Vaccine 2010 conference in Atlanta. Because Atlanta is the epicenter for the HIV/AIDS pandemic in the Southeast, the development of a viable vaccine is a very relevant objective for our community," said Eric Hunter, Ph.D., whose research is conducted at the Emory Vaccine Center. "The devastation of HIV/AIDS is well known, and the need for continued scientific inquiry and global awareness of the disease remains critical in the quest for an effective HIV vaccine."

AIDS Vaccine 2010 aims to help cultivate a global network of scientific talent to carry the field of HIV vaccine research into the future. AIDS Vaccine 2010 will welcome a large cohort of promising early career scientists both nationally and internationally through conference scholarships and travel support.

AIDS Vaccine 2009, with the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) serving as Local Host, will be held in Paris, France from October 19 to 22, 2009. AIDS Vaccine 2008 was held in Cape Town, South Africa.

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Blocking Immune Inhibitor Improves Response to HIV-Like Virus

By blocking PD-1 (programmed death-1), an immune receptor molecule known to inhibit the immune response to chronic viral infections, scientists have safely and significantly reduced the plasma viral load and also prolonged survival of rhesus macaque monkeys severely infected with simian immunodeficiency virus (SIV), the nonhuman primate version of human immunodeficiency virus (HIV). The therapeutic strategy worked by boosting the function of anti-viral killer cells (CD8 T cells) and improving antibody response to the virus.

Scientists at the Yerkes National Primate Research Center of Emory University, the Emory Vaccine Center, Dana-Farber Cancer Institute, Harvard Medical School and the University of Pennsylvania Medical School conducted the research, which will be published in the current online issue of Nature, Dec. 10.

"Our findings raise the possibility that PD-1 blocking antibody treatment not only could improve the anti-viral T cell response to chronic HIV infections, but it also could generate an effective antibody response against the mutated virus of the infected host," says Rama Amara, PhD, principal investigator of the study.

"It also is important to note that this therapy was effective without anti-retroviral drugs and in monkeys with severe AIDS. It is critical to induce protective immune responses targeting the mutated virus for developing a successful immune therapy to control HIV infection," Amara continues.

In the current study, which builds on findings from previous studies with mice, the researchers tested the potential of blocking PD-1 to control HIV infection using a macaque monkey model of SIV. They injected nine SIV-infected monkeys with an antibody to human PD-1 four times over 10 days. Gordon Freeman, PhD, of the Dana-Farber Cancer Institute and Harvard Medical School, provided the antibody.

Of the nine animals, five were infected for three months and four were infected for about 21 months at the time of antibody treatment. Another five SIV-infected monkeys received a control antibody at the same dose and schedule. The researchers then tested the function of the anti-SIV killer cells, antibody responses to the virus and plasma viral load.

Results showed that the improved anti-viral immune responses were associated with a reduction in plasma viral load and prolonged the survival of the infected animals. All nine animals receiving the PD-1 antibody survived more than seven months following initiation of treatment (the current time of the study), while four of the five animals receiving the control antibody died within four months following initiation of treatment.

The antibody treatment appeared to be safe and well tolerated. Within seven days of treatment, the number of anti-SIV killer T cells increased significantly and had improved function. This improvement was noted both in the blood and the gut, which is a major repository of SIV and HIV. The PD-1 antibody treatment also increased the proliferation of memory B cells and the level of antibody against SIV, a finding that had not been reported in earlier mouse studies.

"These findings are important not only because they highlight a potential therapy for HIV, but also because of the insights they offer for other challenging chronic infectious diseases such as hepatitis C virus and tuberculosis," says Emory Vaccine Center Director Rafi Ahmed, PhD, who is a Georgia Research Alliance Eminent Scholar. "Through the Grand Challenges in Global Health initiative, which also funded the current study, we soon will begin testing the effectiveness of the PD-1 blockade against HCV in nonhuman primates."

Several years ago, Ahmed and his colleagues discovered that the immune receptor PD-1 essentially functions as a molecular switch to turn off an effective immune response by overwhelming T cells in their fight against chronic viral infections. By injecting an antibody that binds to PD-1 into mice infected with chronic lymphocytic choriomeningitis virus (LCMV), they were able to switch the immune response back on and control the virus. Dr. Ahmed is a co-principal investigator of the current study.

Other studies have since shown that anti-viral CD8 T cells express high levels of PD-1 during many human chronic infections, including HIV, hepatitis C virus and tuberculosis. However, until now the safety and effectiveness of blocking PD-1 in an appropriate animal model for these human viral infections had not been shown.

The current research team plans to continue testing the antibody therapy in combination with anti-retroviral drugs to try and improve its effectiveness. They also will explore the benefits of prolonged treatment (up to three months as opposed to 10 days in the current study). In addition, they are studying the effectiveness of antibodies against PD-1 ligands (target molecules), a strategy that was part of the earlier mouse research.

The National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, the Foundation for the NIH through the Grand Challenges Global Health Initiative, the Yerkes National Primate Research Center and the Emory Center for AIDS Research supported the current research.

First authors of the paper are Vijayakumar Velu and Kehmia Titanji of the Yerkes National Primate Research Center and the Emory Vaccine Center.

Reference: Enhancing SIV-specific immunity in vivo by PD-1 blockade. Velu, V., Titanji, K., Zhu, B., Husain, S., Pladevega, A., Lai, L., Vanderford, T.H., Chennareddi, L., Silvestri, G., Freeman, G.J., Ahmed, R., Amara, R.R. Nature Online Publication Dec. 10, 2008.

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GeoVax's Phase 2a HIV/AIDS Vaccine Human Trials to Begin in North and South America

/PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC:GOVX) (BULLETIN BOARD: GOVX) , an Atlanta-based biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, announced today that the launch of its Phase 2a Human Vaccine Trials will take place in twelve sites across North and South America. These trials are conducted in collaboration with The National Institutes of Health (NIH), and the HIV Vaccine Trials Network (HVTN).

"It is of significant importance to report this major development on this very day in which the world commemorates WORLD AIDS DAY. Despite setbacks reported recently with other vaccine trials, our vaccine is progressing and paving the way for a solution that would potentially make this commemorative day more joyful," commented Dr. Robert McNally, GeoVax's President and CEO.

Dr. Harriet Robinson, Vice President of Research and Development of GeoVax Labs, Inc., stated, "We feel privileged to be in the position to launch our Phase 2a human trial. Going forward, each clinical site's review board will start the vaccination process, when deemed appropriate and ready. Accordingly, HVTN's pharmacy will release the vaccines to each designated institution as directed by each site's local review board."

Trial site arrangements and other details of the study were confirmed in a recent meeting held in Seattle, Washington, between the HVTN and GeoVax's scientific personnel. The Phase 2a human clinical trial will involve 150 vaccinees and 75 placebo (control) participants. The vaccine regimen employs a two-component "prime-boost strategy." Trial participants will first be administered a GeoVax HIV-1 DNA vaccine which "primes" the immune system followed by the second vaccine, GeoVax's HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines express the three major proteins of the AIDS virus. These proteins mimic more than 50% of the components of the AIDS virus (HIV-1) but cannot cause AIDS. GeoVax AIDS vaccines are designed to prevent HIV-1 virus infection which causes Acquired Immunodeficiency Disease (AIDS).

The Seattle meeting also achieved further progress with GeoVax's therapeutic trial. Information on this and other developments will be reported in a timely fashion in the near future.

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HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief

The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush’s Emergency Plan for AIDS Relief (PEPFAR).

Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.

“HHS/FDA has helped save lives by making high quality, anti-retroviral generic drugs available quickly, at a lower cost, for those most in need under the President’s Emergency Plan," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "As we grant tentative approval for the 75th product, our efforts won't stop: we will continue to provide review of applications for safe and effective treatments for AIDS to combat this global concern."

“Tentative approval" means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of HHS/FDA's normal requirements for manufacturing quality and clinical safety and efficacy.

HHS/FDA performs all of its reviews of applications received in association with the Emergency Plan on an expedited basis; the agency reviewed this application for lamivudine tablets in less than six months. After receiving approval or tentative approval from HHS/FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows HHS/FDA to share data from its evaluations with the WHO team in Geneva. Generic anti-retrovirals given approval or tentative approval by HHS/FDA are also immediately eligible for procurement by recipients of grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria.

In 2003, President George W. Bush launched his Emergency Plan for AIDS Relief to combat global HIV/AIDS – the largest commitment by any nation to combat a single disease in history. At that time, about 50,000 people in sub-Saharan Africa were receiving anti-retroviral treatment. Today, the Emergency Plan reaches more than 1.7 million worldwide with anti-retroviral treatment, the vast majority of them in sub-Saharan Africa, and supports care for more than 6.6 million people, including 2.7 million orphans and vulnerable children. To date, interventions funded by the Emergency Plan have allowed mothers to give birth to nearly 200,000 HIV-free children.

In 2004, HHS/FDA implemented an expedited process under the Emergency Plan to review individual, generic anti-retroviral (ARV) drug formulations, co-packaged versions of individual ARV drug formulations, and fixed-dose ARV combinations. The expedited process includes a commitment by HHS/FDA and the Office of the U.S. Global AIDS Coordinator to work closely with manufacturers before they submit a marketing application to HHS/FDA, especially those firms that have never previously submitted to the agency, and to conduct a priority assessment of those applications.

On July 30, 2008, President Bush signed into law the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008, which reauthorized and expanded the Emergency Plan for five additional years, from 2009 through 2013. The legislation authorizes up to $38 billion over five years for bilateral HIV/AIDS programs under the Emergency Plan, activities under the President’s Malaria Initiative, and bilateral U.S. Government international work against tuberculosis, as well as contributions to the Global Fund.

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