ViroPharma Receives Orphan Drug Designation For Maribavir For Cytomegalovirus Viremia And Disease Indication

ViroPharma Incorporated (Nasdaq: VPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for maribavir for prevention of cytomegalovirus (CMV) viremia and disease in the populations at-risk.

The Orphan Drug Act was designed to provide incentives to companies to develop drugs that treat conditions affecting 200,000 or fewer patients annually in the U.S. and that provide a significant therapeutic advantage over existing treatments or fill an unmet medical need. Orphan drug designation entitles ViroPharma to seven years of market exclusivity in the United States upon FDA approval of maribavir, provided that the company continues to meet certain conditions established by the FDA. Other potential advantages include protocol assistance, the potential for priority review, tax credits, and other financial incentives.

“We are particularly pleased to receive orphan designation for the product from the FDA,” commented Colin Broom, M.D., ViroPharma’s chief scientific officer. “We have made excellent progress with maribavir over the last 12 months. We demonstrated in a Phase 2 clinical trial that the drug appears to be well tolerated with impressive anti-CMV activity in stem cell transplant patients, which has allowed us to initiate our international Phase 3 development program. The receipt of this designation marks one more important milestone in the development of the compound. Maribavir is an important Phase 3 drug candidate for a significant unmet medical need, and may one day provide an effective and well tolerated therapeutic alternative for patients at risk of CMV disease.”

About Maribavir

Maribavir is a potent and selective, orally bioavailable antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable early clinical safety profile. It is a potent member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and egress of viral capsids from the nucleus of infected cells. Maribavir is also active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs.

About Cytomegalovirus

CMV is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50% and 85% of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.

About ViroPharma Incorporated

ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R) approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin- resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/Vancocin_pi_2007.htm). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the Company’s website at http://www.viropharma.com/.

Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including those relating to our hope that maribavir may offer transplant patients a better tolerated, efficacious treatment option. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. There can be no assurance that that maribavir will ever be approved by the FDA. These factors, and other factors, including, but not limited to those described in ViroPharma’s quarterly report on Form 10-Q for the quarters ended March 31, 2006, June 30, 2006 and September 30, 2006 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.

ViroPharma Incorporated
http://www.viropharma.com/

UNAIDS To Introduce HIV Testing Guidelines In India That Recommend Provider-Initiated Testing, Counseling

UNAIDS in March plans to introduce new HIV testing guidelines in India that recommend health care providers initiate testing and counseling, the Hindustan Times reports. Under the country’s current HIV testing policy, tests are provided only when people request them. Requests for HIV tests in general are low, and about one in 10 HIV-positive people in India are aware of their status, the Times reports. The new guidelines emphasize informed consent and counseling before an HIV test can be administered, according to the Times. Denis Broun, UNAIDS India coordinator, said the group does not “support mandatory testing. Testing must be confidential, include counseling and occur only with informed consent.” He added that no one will be “forced into testing, as the rules of opting out are very clear.” In addition, the new testing guidelines will “phenomenally” increase the number of people receiving HIV tests in the country, Broun said, adding that the guidelines “aim to reach the nine in 10 undiagnosed [HIV-positive] people who miss out on treatment.” However, some human rights advocates have said that India does not have the health infrastructure to provide treatment and care for the thousands of people who will test positive for HIV, the Times reports. “The government cannot test people and send them away,” Anjali Gopalan, executive director of Naz Foundation India Trust, said, adding, “India first needs to ensure proper counseling, upgrade voluntary testing and counseling centers, and set up the required facilities in states that have no health infrastructure or social security for people to fall back on.” Loon Gangte, president of the Delhi Network of Positive People, said, “Before scaling up HIV testing, the government must ensure there is no stigma and discrimination” against HIV-positive people. He added that the government “must also provide assured access to treatment and care services.” According to Broun, provider-initiated testing has increased the number of people receiving HIV tests in several East African countries, including Botswana, Malawi and Uganda (Sharma, Hindustan Times, 2/1).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Boston Globe Reports On Internal Investigation Of Global Fund Practices

The Boston Globe on Monday reported on an internal inspector general investigation into the business expense practices of the executive director of the Global Fund To Fight AIDS, Tuberculosis and Malaria. According to the Globe’s description of the investigation, which was completed in August 2006, Global Fund Executive Director Richard Feachem has “made extensive use of a little-known private bank account, spending hundreds of thousands of dollars on limousines, expensive meals, boat cruises and other expenses.” According to the Globe, a separate investigation by the World Health Organization also “raised concerns” over use of the account. Global Fund spokesperson Jon Liden said, “These expenses are reasonable and necessary for carrying out the business of the Global Fund,” adding that the report is of “extraordinarily poor quality in terms of accuracy, context and fairness. We have nothing to hide.” (Donnelly, Boston Globe, 2/5) The Global Fund in a release on Monday provided comments and clarifications on a “number of untrue or misleading statements” made in the Globe article (Global Fund release, 2/5).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Washington County Records Four Cases Of Drug-Resistant HIV

Four men in King County, Washington, have been diagnosed with a strain of HIV that is resistant to at least two types of antiretroviral drugs, and health officials on Thursday said they are concerned the strain could spread, the Seattle Times reports. According to the Times, a third antiretroviral has limited effectiveness against the strain (King, Seattle Times, 2/2). Officials said that the same genetic strain of HIV was recorded within 15 months among the men, who were diagnosed with the drug-resistant strain as soon as they tested HIV positive. The men used methamphetamine and had multiple anonymous sexual partners, including men. None of the men was known to have had sex with any of the other three, according to officials (AP/Houston Chronicle, 2/2). Some of the men’s partners have been identified, none of whom has tested positive for the resistant strain, Bob Wood, HIV/AIDS program director for the Seattle-King County Public Health Department, said. There is no information about how easily this strain might be transmitted or whether it was spread to Seattle from another city. The agency plans to distribute fliers in gay bars and bathhouses about the HIV strain, and physicians are being asked to test all newly diagnosed HIV cases for drug resistance and report them to the health department, Wood said. According to physicians, it is unlikely the drug-resistant HIV strain will cause the men to progress more rapidly to AIDS; however, once they do progress to the disease, treating them will be more difficult (Seattle Times, 2/2). Health officials as of last week had recorded 12 cases of multidrug-resistant HIV in the county, but none of the cases was as resistant to antiretrovirals as the most recent four, the AP/Chronicle reports (AP/Houston Chronicle, 2/2). About 350 to 400 new HIV cases are reported in King County annually, and about 8,000 county residents are living with the virus. Wood said the new cases should serve as an early warning because “they show there is some ongoing transmission” (Seattle Times, 2/2). Wood added, “This is mostly about behavior. Men who have sex with men need to know that drug-resistant strains can and are being transmitted and may be much less treatable” (Paulson, Seattle Post-Intelligencer, 2/2).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Study Examines Reliability Of ‘Probe To Bone’ Test

An often-used tool to diagnose very common and sometimes limb-threatening bone infections in persons with diabetes may not be as reliable as many once believed, based on a recent study by a transatlantic team of researchers. The study, published to the Web ahead of print in February’s edition of the journal Diabetes Care, longitudinally evaluated a large sample of persons with diabetes with wounds, and tested the commonly performed “probe to bone” test. The test, which uses a sterile instrument to feel for bone inside a wound, has been thought by many to be highly predictive of bone infection.

“It certainly makes sense that if you can feel bone, then it must be infected,” noted David G. Armstrong, DPM, PhD, Professor of Surgery at Scholl’s Center for Lower Extremity Ambulatory Research (CLEAR) at Rosalind Franklin University of Medicine and Science, and a co-investigator on the study. “Unfortunately, though, this doesn’t always seem to be the case. The test, if used by itself in a normal clinical setting, isn’t much better than flipping a coin. We therefore recommend it be used with other aids, such as biopsy or appropriate imaging tools.”

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The two-year longitudinal study was the result of partnerships from Texas A&M University, Rosalind Franklin University of Medicine and Science, the Leiden University Medical Center (Netherlands) and the University of Washington School of Medicine.

Rosalind Franklin University of Medicine and Science educates medical doctors, health professionals and biomedical scientists in a personalized atmosphere. The University is located at 3333 Green Bay Road, North Chicago, IL 60064, and encompasses Chicago Medical School, College of Health Professions, Dr. William M. Scholl College of Podiatric Medicine, and School of Graduate and Postdoctoral Studies. Visit at http://www.rosalindfranklin.edu/ and http://www.lifeindiscovery.com/.

Contact: Kathy Peterson
Rosalind Franklin University of Medicine and Science

Bush FY 2008 Budget Proposal Would Allocate $5.4B For PEPFAR

President Bush on Monday released his $2.8 trillion fiscal year 2008 budget proposal, which would allocate $5.4 billion for the President’s Emergency Plan for AIDS Relief, the Wall Street Journal reports (Phillips, Wall Street Journal, 2/6). Bush’s budget proposal would allocate $4.2 billion for treatment, prevention and care initiatives to PEPFAR’s 15 focus countries, as well as an additional $1.2 billion for global HIV/AIDS programs, disease research and contributions to partner organizations (President’s FY 2008 budget, 2/5). Included in the PEPFAR budget, Bush has asked for $300 million for the Global Fund To Fight AIDS, Tuberculosis and Malaria and $491 million for other activities, including TB programs (PEPFAR.gov release, 2/2). In addition to the PEPFAR funding, the budget proposal would provide $300 million for the President’s Malaria Initiative and ongoing malaria programs worldwide (President’s FY 2008 budget, 2/5). The budget proposal also calls for $3 billion for the Millennium Challenge Corporation, a program meant to encourage economic and political reforms in developing countries, VOA News reports (VOA News, 2/5). Bush’s budget proposal comes a week after the House voted 286-140 to approve a $463 billion spending resolution (HJ Res 20) for FY 2007 that includes a $1.3 billion increase for PEPFAR. The resolution would bring the total for PEPFAR to $4.5 billion and would allocate $724 million for the U.S. contribution to the Global Fund. In addition, $248 million would be allocated to expand programs under PMI, an increase of $149 million. The Senate is expected to consider the bill this week (Kaiser Daily HIV/AIDS Report, 2/2). “The Global fund will need $1.4 billion from the U.S., as well as added funding from the rest of the world,” Friends of the Global Fight President Jack Valenti said, adding, “We are concerned that without additional funds, a lot of people will die. In the upcoming year, I look forward to working with the [Bush] administration and Congress to fully fund the Global Fund and the president’s programs” (Friends of the Global Fight release, 2/5).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Chinese Authorities Prevent HIV/AIDS Advocate From Coming To U.S. To Accept Award

Chinese HIV/AIDS advocate and retired physician Gao Yaojie last week was put under house arrest by Chinese authorities to prevent her from visiting the U.S. next month to accept an award from the group Vital Voices Global Partnership, the New York Times reports (Yardley, New York Times, 2/6). According to Gao’s friend and Beijing-based AIDS advocate Hu Jia, Chinese authorities from the eastern province Henan told Gao not to attend the Vital Voices awards ceremony, the AP/Washington Post reports. When Gao refused, she was put under house arrest to prevent her from traveling to Beijing to apply for a U.S. visa, Hu said. Gao’s friends and family were blocked from visiting her or were questioned before being given permission to visit, and her daughter is under police surveillance, Hu said (Olesen, AP/Washington Post, 2/4). A spokesperson for the U.S. Embassy in Beijing said the embassy had “raised the issue [of Gao's house arrest] with the Chinese Ministry of Foreign Affairs” but did not give details, according to Reuters UK (Reuters UK, 2/5). Gao in the 1990s alerted people in Henan of HIV cases that occurred through tainted blood transfusions (AP/Washington Post, 2/4). Gao also distributed material warning people of HIV and the risks of donating blood, Reuters UK reports (Reuters UK, 2/5). In addition, Gao has distributed medicine to HIV-positive people, provided cared for AIDS orphans and hosted people living with HIV/AIDS in her home. She also has written a book about the HIV/AIDS epidemic in China, the AP/Post reports (AP/Washington Post, 2/4). Chinese authorities in 2001 and 2003 prevented Gao from traveling abroad to accept awards for her work, Reuters UK reports (Reuters UK, 2/5). “We would like to believe that this is a misunderstanding because Dr. Gao has been publicly recognized by the Chinese government many times,” Wenchi Yu Perkins, Vital Voices’ human rights program director, said, adding, “We are talking to our contacts in China to understand what is happening.” Chinese Foreign Ministry spokesperson Jiang Yu on Tuesday said that she is not aware of Gao’s situation. China is a “country ruled by law” that “protect[s] the rights of all citizens,” she said, adding, “Nobody has the right to be above the law” (Olesen, AP/Forbes, 2/6).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Changes In Amino Acids In The 1918 Influenza Virus Cut Transmission

Modest changes in the 1918 flu virus’s hemagglutinin receptor binding site – a molecular structure critical for the spread of infection- -stopped viral transmission in ferrets, according to a new study conducted by researchers at Mount Sinai School of Medicine and at the Centers for Disease Control and Prevention. The finding, published in Science, could have significant clinical implications in helping scientists develop ways to break the disease cycle and possibly help reduce the risk for a potential pandemic.

While flu pandemics occur every 10 to 40 years, the factors that lead to the emergence of pandemic viruses are not well understood, explains study co-author Adolfo GarcГ­a-Sastre, PhD, Professor of Microbiology at Mount Sinai School of Medicine. “What’s most threatening is the possibility of another pandemic, similar to that of 1918, which was caused by a novel influenza subtype virus capable of causing severe respiratory disease and death,” says Dr. GarcГ­a-Sastre. “So if we can understand the molecular mechanisms behind its transmission, perhaps we can do something to block transmission and prevent illness.”

To do this, Dr. GarcГ­a-Sastre and his team studied two key molecular structures: hemagglutinin, a protein located in of the surface of the influenza virus, and sialic acid, a cellular molecule that is recognized by hemaglutinins of both human and avian strains of influenza virus. These molecules are key to initiation of infection. There are 16 different subtypes of hemagglutinin called H1 through H16, present in influenza virus strains circulating in birds. H1 and H3 are found today in human influenza viruses.

Hemaglutinin helps open the door to the cell to allow the virus to infect. The first step is in this process is the binding of the hemagglutinin to sialic acid containing molecules in the cell surface. There are two primary ways sialic acids are associated with molecules in the cell surface – one is through an alpha-2,6 bond and another is through an alpha-2,3 bond. Hemagglutinins from avian influenza virus prefer binding to alpha 2-3 sialic acids, while hemagglutinins from human influenza viruses prefer binding to alpha 2-6 sialic acids, which are highly abundant in the upper respiratory tract of humans. For an avian virus to be able to jump to humans and to start a new pandemic, it has been hypothesized that the hemagglutinin needs to mutate and change its binding preference from alpha2-3 to alpha2-6 sialic acids.

In this study, the researchers used ferrets as an animal model of human influenza virus infection, due to the presence of alpha2-6 sialic acids in the respiratory tract of ferrets, similar to the human scenario. Groups of ferrets were infected with three types of influenza viruses; two from existing viral strains related to the 1918 flu and taken from human tissue, and the third, which was artificially created in a laboratory and made to look like avian flu. One virus bound to only alpha-2,6, the second bound to both, and the artificially-generated virus bound to only alpha-2,3.

The researchers were surprised to discover that the ferrets infected with all three viruses, including the one with preference for binding to alpha2-3 sialic acids, experienced severe disease, with high levels of virus replication in the respiratory tract. However, only the virus with specificity for binding to alpha2-6 silaic acids was able to transmit by aerosols to contact ferrets. “It appears that when the virus only had an alpha-2,3 binding activity, replication and virulence didn’t change,” explains Dr. GarcГ­a-Sastre. “These animals still had symptoms, however transmission was practically abolished.” Since the artificially-generated virus featured alpha-2,3 sialic acid binding activity, this finding indicated that alpha-2,6 sialic acid binding activity was more important for optimal viral transmission. “Our findings indicate that, to become more transmissible in humans, the currently circulating avian influenza H5N1 virus requires a receptor binding change in the hemagglutinin to a predominant alpha-2,6 sialic acid binding preference,” Dr. GarcГ­a-Sastre adds. “Although this is likely not to be the only change required by H5N1 viruses to become transmissible in humans, this could help us make more accurate predictions on the ability of an influenza virus to transmit among humans and unravels the existence of molecular determinants of transmission that could be used as targets for the development of novel drugs that will stop influenza virus transmission, and therefore, help to stop epidemics and pandemics of influenza.”

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About The Mount Sinai Hospital

The Mount Sinai Hospital is one of the nation’s oldest, largest and most-respected voluntary hospitals. Founded in 1852, Mount Sinai today is a 1,171-bed tertiary-care teaching facility that is internationally acclaimed for excellence in clinical care.

About Mount Sinai School of Medicine

Located in Manhattan, Mount Sinai School of Medicine is internationally recognized for ground-breaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. One indication of Mount Sinai’s leadership in scientific investigation is its receipt during fiscal year 2005 of $174.1 million in research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like The Morchand Center, the nation’s largest program teaching students and physicians with “standardized patients” to become not only highly skilled, but compassionate caregivers. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.

Contact: Mount Sinai Press Office
The Mount Sinai Hospital / Mount Sinai School of Medicine

Preclinical Results Of Geovax’s AIDS Vaccines Demonstrate Potential To Protect Against Disease

GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based biotechnology company, have reported successful results from a preclinical trial using GeoVax’s vaccines for the therapeutic treatment and prevention of Acquired Immunodeficiency Disease Syndrome (“AIDS”) in non-human primates. The data demonstrate the effectiveness of GeoVax’s DNA/MVA vaccines in controlling the Simian (“SIV”) AIDS virus through immune responses raised by the vaccines. These promising results have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax’s vaccines.

In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax’s DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later “controlled” (reduced to much lower levels) by immune responses raised by the vaccines.

The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.

“The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS,” said Don Hildebrand, CEO of GeoVax Labs. “Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines.”

The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus’ progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.

The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax’s AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.

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These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.

Safe Harbor Statement

All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax’s vaccines will be determined to be safe for use in humans, GeoVax’s vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.

Contact: Melanie Nimrodi
Financial Relations Board

Cincinnati Researchers Publish Pioneering Work Characterizing The Basis For Predisposition To Infection In Deadly Lung Disease

Researchers at Cincinnati Children’s Hospital Medical Center and University of Cincinnati have published pioneering work characterizing the molecular defect contributing to the predisposition to microbial infection in people with Pulmonary Alveolar Proteinosis (PAP), a rare lung disorder that can lead to respiratory failure and death. Their findings suggest that patients with PAP are unable to mount an effective defense against microbes due to severe functional impairment of an important class of white blood cells called neutrophils. The study published in the Feb. 8, 2007 edition of the New England Journal of Medicine also highlighted the importance of the immune system regulator Granulocyte-Macrophage-Colony Stimulating Factor (GM-CSF) in securing resistance against microbes.

“Clinical investigations and effective translation of findings from the bench to the bedside have considerably changed our concepts of the pathogenesis and treatment of PAP,” said Bruce Trapnell, M.D., M.S., senior author of the study and Director of the Rare Lung Diseases Consortium, and the Cystic Fibrosis Therapeutics Development Network Center at Cincinnati Children’s Hospital Medical Center, and Associate Director of the Adult Cystic Fibrosis Center at the University of Cincinnati. “In addition to illuminating the mechanism of this disorder, these results provide support for the feasibility of therapies that modulate GM-CSF activity to stimulate immune defenses in patients with serious infections and reduce neutrophil priming in patients with chronic inflammatory disorders.”

PAP is characterized by an increased incidence of mortality caused by microbial infections. This susceptibility to infection is attributed to a defect in the body’s ability to mount an effective immune response that consequently impairs its normal capacity to kill microbes and avert infection. Previous evidence had suggested that a potentially important underlying cause of PAP was misguided generation of antibodies to GM-CSF, a molecule known to be important to the function of neutrophils, by the PAP patient’s immune system.

The Cincinnati researchers tested neutrophil functions in patients with PAP, mice lacking the protein GM-CSF and control subjects. The results showed that neutrophils from patients with PAP have wide ranging defects in antimicrobial functions owing to the presence of GM-CSF antibodies. The effects of these antibodies show that GM-CSF is an essential regulator of neutrophil functions.

“This is an important development in our understanding PAP and provides new hope for the future treatment of this serious and deadly condition, said Louie Schimpf, president of the PAP foundation.

About Pulmonary Alveolar Proteinosis

Pulmonary alveolar proteinosis is an extremely rare disease in which a fluid accumulates within spaces in the lungs where oxygen and carbon dioxide are exchanged. Symptoms include a persistent, unproductive cough, weight loss, fatigue and shortness of breath. Standard treatment consists of periodic whole-lung lavage, which is performed routinely at the Cincinnati Children’s Hospital and University of Cincinnati Medical Centers. Additional information can be found at http://www.papfoundation.org.

About the Rare Lung Diseases Consortium

The Rare Lung Diseases Consortium (RLDC) is a network of cooperating clinical centers and patient support organizations who are working with the National Institutes of Health (NIH) in a collaborative network whose novel structure is designed to accelerate clinical research and improve the delivery of medical care to individuals affected by rare lung diseases. Additional information can be found at http://www.rarediseasesnetwork.org.

Cincinnati Children’s Hospital Medical Center

Cincinnati Children’s Hospital Medical Center, one of the leading pediatric research institutions in the nation, is dedicated to changing the outcome for children throughout the world. Cincinnati Children’s ranks second among all pediatric institutions in the United States in grants from the National Institutes of Health. It has an established tradition of research excellence, with discoveries including the Sabin oral polio vaccine, the surfactant preparation that saves the lives of thousands of premature infants each year, and a rotavirus vaccine that saves the lives of hundreds of thousands of infants around the world each year. Current strategic directions include the translation of basic laboratory research into the development of novel therapeutics for the treatment of disease, and furthering the development of personalized and predictive medicine. Additional information can be found at http://www.cincinnatichildrens.org.

Cincinnati Children’s Hospital Medical Center
http://www.cincinnatichildrens.org