Patient / Public:
Health Professional:
Article Opinions:	0 posts

TIME examines a voluntary airline tax, to be introduced in the U.S. and several European countries in January, that aims to “make up a shortfall in official government aid to poor countries - a shortfall exacerbated by the world financial crisis.” The tax will be used to combat HIV/AIDS, tuberculosis and malaria, and it will also go towards improving maternal health and reducing child mortality.

The $2 tax - which is backed by the travel industry and organizations, including the William J. Clinton Foundation and the Bill & Melinda Gates Foundation - is “the brainchild of Philippe Douste-Blazy, a former French foreign minister” who runs UNITAID, the magazine writes, noting that it is “no accident that he’s a Frenchman: the French have for several years levied a compulsory tax on airline tickets to help fund development projects and have long sought to get others to join them, with mixed success.”

The voluntary tax “will be formally announced in New York on Sept. 23 on the fringes of the U.N. General Assembly … British Prime Minister Gordon Brown and the head of the World Bank, Robert Zoellick, are expected to participate in the launch, as well as the chief executives of the three companies that have made it technically possible: Amadeus, Sabre and Travelport/Galileo, who run the reservation and ticketing systems for most of the world’s airlines,” according to TIME.

The tax could raise up to $1 billion per year, according to estimates by consultants McKinsey & Co., and could help achieve U.N. Millennium Development Goal targets. Douste-Blazy has also said that administrative expenses will be minimal, “especially by U.N. standards - less than 5% of the money raised,” according to TIME.

Bjorn Skogno, a senior official in the Norwegian Foreign Ministry who is involved with the project, said, development aid “is likely to go down because of the [financial] crisis, so there’s a need to be innovative to find new sources of funds.” The article also discusses preparations for the launch of the tax and the chances of its success (Gumbel, 9/18).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Terrence Higgins Trust (THT) launches a major new awareness raising campaign aimed at gay men in London. ‘Assumptions’ is aimed at men who don’t use condoms because they think they have correctly identified their partner’s status. This campaign urges men not to assume that they ‘know’ the HIV status of a new partner.

Research shows that some gay men ’sort’ potential sexual partners based on first impressions and assumptions rather than actual disclosure. Many still believe that they can tell someone’s HIV status based on a person’s appearance, or their approach towards unprotected sex. This campaign challenges men to reconsider this assumption. It also highlights the fact this strategy significantly increases the risk of HIV transmission and acquiring other sexually transmitted infections (STIs).

‘Assumptions’ consists of a series of three adverts. Each advert features two men having sex and in each scenario, the differing points of view of each man are presented with one man believing: ‘He’s not mentioned condoms. He’s gotta be positive like me’, whilst the other thinks: ‘No condom, so he’s probably negative too’. The strapline of the campaign says: ‘Don’t assume you’re both thinking the same thing.’

Marc Thompson, Deputy Head of Health Promotion for THT said: “We know that some men make a decision to have unprotected sex with someone who they believe shares their HIV status - whether that’s positive or negative. The fact is this approach dramatically increases the risk of HIV as well as other STIs being passed on. We hope this campaign will encourage gay men to think about the assumptions they make about the status of their partner before they have sex. Ultimately we hope ‘Assumptions’ will reduce the number of new HIV infections amongst gay men in London.

The new campaign will run for twelve weeks. There will be adverts in the gay press, posters in bars and saunas and a banner ad online directing men to find out more about ‘Assumptions’.

The ‘Assumptions’ campaign has been funded by the Pan London HIV Prevention Partnership. Men can find out more by visiting http://www.gmfa.org.uk/assumptions.

Source
Terrence Higgins Trust

Patient / Public:
Health Professional:
Article Opinions:	0 posts

IRIN examines how a recent resolution to create an agency to promote women’s “rights and wellbeing” by the U.N. General Assembly is being welcomed by international HIV/AIDS advocates. According to IRIN, “[w]omen make up 60 percent of people living with AIDS in sub-Saharan Africa, a figure that rises to 75 percent in the 15-24 age range. In Asia, nearly 50 million women are at risk of becoming infected with HIV from their partners.”

The agency is seen as “long overdue” by some HIV/AIDS advocates. “‘We see this not as an end but a beginning - the U.N.’s first attempt to form a serious gender entity, and the Secretary-General’s opportunity to make a monumental change both in the way the U.N. operates, and in the lives of women everywhere,’ said Stephen Lewis, co-director of AIDS-Free World and former U.N. special envoy for HIV/AIDS in Africa,” IRIN writes.

“We hope the new agency will help with advocacy around women’s issues, and will lead to more grass-roots support for HIV-positive women,” Marion Natukunda, project director for a Ugandan NGO, said. According to IRIN, “AIDS-Free World urged U.N. Secretary-General Ban Ki-moon to reserve a seat for the head of the women’s agency on the Committee of Co-sponsoring Organizations that comprise UNAIDS” (9/18).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Patient / Public:
Health Professional:
Article Opinions:	0 posts

Post Of Zambia Examines Toll Of HIV/AIDS On Country

The Post of Zambia examines the findings of a recent report revealing “the devastating effects” the HIV/AIDS epidemic in Zambia is having on the country’s ability to meet the U.N. Millennium Development Goals. The article also looks at the relationship between HIV/AIDS and nutrition, maternal health and education (Chackwe, 9/21).

Ugandan Government Works To Attract Medical Workers

The Ugandan government will soon begin centralizing the recruitment of medical workers in an effort to improve health services and reduce health worker shortages, Health Minister Stephen Mallinga announced Wednesday, the New Vision/allAfrica.com reports (Edyegu, 9/18).

Science Insider Blog Features Interview With U.S. Global AIDS Coordinator

Science magazine’s “Science Insider” blog interviewed Eric Goosby before his official swearing-in ceremony last week as the Global AIDS Coordinator and Ambassador-at-Large for the U.S. government. The interview covers several topics, including his plans for PEPFAR, targeting the demographic of the HIV epidemic and funding ideas (9/18).

Carson Speech Published By AllAfrica.com

allAfrica.com published a transcript of Assistant Secretary of State for Africa Johnnie Carson’s recent speech at the Center for American Progress in Washington, D.C. The Obama administration “will also continue to maintain our historical focus on health issues with a particular emphasis on public health and the strengthening of African delivery systems to provide the kinds of access, treatment and prevention that remain essential for progress in most other areas,” Carson said (9/17).

AP/Washington Post Examines South African Health Care Reform Efforts

South Africa’s “governing African National Congress party wants to pass universal health insurance before President Jacob Zuma’s first term ends in five years,” and most people in the country “believe the plan will pass,” the Associated Press/Washington Post reports. The article includes quotes from a public forum addressing the country’s health care system and notes that questions remain about how reform “could be funded and whether it would fix the troubled health system in South Africa, which has an estimated 5.5 million people living with HIV - the highest total of any country” (Bryson, 9/17).

African Countries Use Text Messages To Report Local Drug Shortages

PlusNews/IRIN examines how a program launched earlier this year in Kenya, Uganda, Malawi and Zambia is helping people to use text messages to report shortages of “essential medicines to treat common diseases such as malaria, pneumonia, diarrhoea, HIV and tuberculosis” at their local clinics or hospital pharmacies. “Stock-outs often mean that poor patients, who cannot afford to travel to other health facilities or to buy drugs from the private sector, simply go without, risking serious health consequences,” the news service writes (9/17).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Patient / Public:
Health Professional:
Article Opinions:	0 posts

UNAIDS Executive Director Michel Sidibe in New York on Monday signed a partnership agreement with several non-governmental organizations (NGOs) pledging to work towards eliminating mother-to-child transmission of HIV in Africa, Agence France-Presse reports. Presidents Abdoulaye Wade of Senegal and Yoweri Museveni of Uganda attended the signing ceremony.

“Signatories include Columbia University’s Earth Institute led by leading U.S. economist Jeffrey Sachs and the Millennium Promise Alliance, an advocacy group pushing for implementation of the” Millennium Development Goals in Africa, the news service writes. The agreement, “signed as world leaders gathered here for this week’s U.N. General Assembly session, aims to accelerate action on HIV/AIDS and ‘correct the glaring inequality’ faced by children in the face of the scourge … Sidibe told a press conference.” According to Sidibe, each year more than 300,000 babies are born HIV positive, “most of them in Africa and 30 percent of them died before their first birthday, he added.”

The agreement aims to prevent women from acquiring HIV, prevent unintended pregnancies, prevent the mother-to-child transmission of the virus and offer services to women and children affected by the disease (9/21). A UNAIDS press release provides additional information on the specifics of programs working to achieve the goals of the agreement (9/21).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Four scientists have been selected as this year’s winners of the Avant-Garde Award for HIV/AIDS research, the National Institute on Drug Abuse, part of the National Institutes of Health, announced today. The annual award competition, now in its second year, is intended to stimulate high-impact research that may lead to groundbreaking opportunities for the prevention and treatment of HIV/AIDS in drug abusers. Winning scientists receive $500,000 per year, plus associated facilities and administrative costs, for five years to support their research.

The four awardees will undertake diverse approaches in their research on HIV. One scientist will investigate the interactions that occur between HIV-infected and uninfected cells during intravenous transmission. Another researcher is developing new strategies to restore the immune system of HIV-infected individuals. The third will work on developing a new technology that exploits a silencing mechanism to block HIV transcription. The last will focus on identifying and eliminating latent HIV infection. This collective research will further NIDA’s work to learn more about the pivotal role of drug abuse in the spread of HIV/AIDS and to develop effective strategies to prevent and treat this disease.

The Avant-Garde Awards are modeled after the NIH Pioneer Awards and are granted to scientists of exceptional creativity who propose high-impact research that will open new avenues for prevention and treatment of HIV/AIDS among drug abusers. “By supporting bold investigators with unexplored ideas, we hope we can find new approaches to eradicating the terrible public health toll of HIV/AIDS,” said NIH Director Francis Collins.

“This year’s Avant-Garde recipients proposed some especially exciting research directions,” said NIDA Director Nora D. Volkow, who announced the awards. “These studies of fundamental processes in HIV infection should move us ahead by leaps and bounds in our efforts to find solutions to HIV/AIDS.”

The Avant-Garde Awardees were selected from 39 applicants whose proposals reflect diverse scientific disciplines and approaches to HIV/AIDS research. The Avant-Garde Awards were granted to the following researchers:

Awardee: Benjamin K. Chen, M.D., Ph.D., assistant professor in the Department of Infectious Diseases at Mount Sinai School of Medicine, New York, is an investigator of exceptional vision and promise. He developed methodology that enables visualization of fluorescently tagged HIV virus particles that may answer long-standing questions about cell-cell mechanisms of viral transmission.

Project: Imaging Virological Synapses During Parenteral HIV Transmission

The understanding of how the HIV virus spreads among injection drug users is limited by a poor understanding of the first events that occur following HIV transmission. This research uses sensitive virus tagging approaches and mouse models with humanized immune systems to study the sequence of interactions between HIV-infected cells and uninfected cells. These studies may lead to the development of vaccines or other preventive approaches to inhibit these initial interactions that occur during intravenous transmission.

Awardee: Dana H. Gabuzda, M.D., is a professor of neurology (microbiology) at the Dana Farber Cancer Institute and Harvard Medical School, in Boston. Dr. Gabuzda is a leading researcher in the areas of HIV molecular biology and pathogenesis, particularly neuropathogenesis. Her cutting-edge research has significantly increased understanding of HIV replication and pathogenesis.

Project: Systems Biology of Immune Reconstitution in HIV/AIDS

A major challenge in HIV research is to restore immune function in HIV-infected individuals. HIV infection depletes CD4 T cells, leading to immunodeficiency and death. Highly active anti-retroviral therapy (HAART) restores CD4 T cell counts to normal levels in a majority of individuals who achieve suppression of HIV to undetectable levels. However, the magnitude of CD4 T cell recovery is variable and many people on HAART have poor CD4 T cell recovery. The research will lead to a better understanding of the mechanisms that determine CD4 T cell restoration in IV drug abusers and other populations infected with HIV, and may identify new therapeutic strategies to improve restoration of immune function in these populations.

Awardee: Jonathan Karn, Ph.D., is a professor and chairman of molecular biology and microbiology at Case Western Reserve University, in Cleveland. Dr. Karn is a creative molecular biologist whose research on novel therapeutic technologies could have an impact on the HIV/AIDS epidemic worldwide.

Project: Manipulating Epigenetic Control Mechanisms to Control HIV Transcription

Most individuals treated with antiretroviral drugs have little to no detectable HIV in their blood, however, this does not mean that the virus has been cleared from the body. Unfortunately, the virus can re-emerge, leading to renewed active infections when treatment stops or fails. This research will focus on finding natural mechanisms that could block HIV replication and provide long-lasting suppression of HIV.

Awardee: Rafick-Pierre Sekaly, Ph.D., scientific director and co-director of the Oregon Health and Science University Vaccine and Gene Therapy Institute in Portland is an internationally recognized leader in the field of human immunology and translational medicine, specifically the immune response to HIV infection.

Project: Novel Concepts for the Eradication of HIV

The HIV-1 reservoir is a small pool of persistent long-lived and latently infected resting memory CD4 T cells. Eradication of this HIV reservoir is one of the last steps to be conquered in order to develop a cure for this disease. Dr. Sekaly’s research will probe for a mechanism explaining the existence of HIV reservoirs. His studies of pathways that can be targeted to purge HIV from its reservoir could ultimately lead to novel immunological interventions for the treatment of HIV.

NIDA’s HIV/AIDS Research Program supports a multidisciplinary portfolio that investigates the role of drug use and its related behaviors in the evolving dynamics of HIV/AIDS epidemiology, natural history/pathogenesis, treatment, and prevention. http://www.drugabuse.gov/AIDS.

For further information about the Avant-Garde Award, please visit the NIDA Avant-Garde Award Web site at http://drugabuse.gov/avgp.html. Information about the FY10 Avant-Garde award will be posted on this site soon.

Source
The National Institute on Drug Abuse

Scientists working to develop a vaccine for the human immunodeficiency virus (HIV) report they have created the first antigen that induces protective antibodies capable of blocking infection of human cells by genetically-diverse strains of HIV. The new antigen differs from previously-tested vaccines by virtue of its chemically-activated property that enables close sharing of electrons and produces strong covalent bonding. Researchers used a mouse model to generate the antibodies. The report by researchers at The University of Texas Health Science Center at Houston is online and will appear in a print issue of the Journal of Biological Chemistry in November.

“The complexity of HIV has for long thwarted development of an effective HIV vaccine. Our findings open a new path toward an effective preventative and therapeutic vaccine,” said Sudhir Paul, Ph.D., the study’s senior author and a professor in the Department of Pathology and Laboratory Medicine at The University of Texas Medical School at Houston. “The new antigen is a prototype vaccine. This prototype successfully eliminates nature’s restrictions on the production of broadly-neutralizing antibodies to HIV by the immune system.”

Thirty-three million people were living with HIV at the end of 2007, according to the World Health Organization. That same year, nearly 3 million people became newly infected, and 2 million died of acquired immunodeficiency syndrome or AIDS, which occurs at the most advanced stages of HIV infection. Vaccines work by introducing an antigen into the body, which spurs the immune system to produce antibodies that guard against infection. Previously-tested HIV vaccine candidates stimulated vigorous production of antibodies to the mutable segments of the virus envelope. But, these vaccine candidates did not stimulate the production of antibodies to the regions essential for virus attachment to host T cells, the process that initiates infection.

Scientists in Paul’s laboratory used a chemically-activated form of the HIV envelope protein gp120 to stimulate the production of mouse monoclonal antibodies that block infection of cultured human cells by genetically-diverse HIV strains from around the world. Paul said these same antibodies can be found in humans who remain free of AIDS despite long-term HIV infection. “HIV infection itself stimulates production of this class of antibodies, but the amount is too small to control infection. The challenge is to boost production of the protective antibodies in humans using a vaccine.”

Because of the genetic variability of HIV, most antibodies fail to stop infection initiated by thousands of different HIV strains responsible for the pandemic. “Dr. Paul’s team has developed a revolutionary antibody technology and used it to overcome major obstacles to a vaccine for HIV. They identified antibodies that neutralized 100 percent of strains drawn from the major viral subtypes. Furthermore, they have developed ways to immunize animals to produce them. No previous vaccine candidate has even approached these objectives,” said Robert L. Hunter, M.D., Ph.D., professor and chairman of the Department of Pathology and Laboratory Medicine at the UT Medical School at Houston.

The vaccine prototype builds on Paul’s earlier discovery that a tiny stretch of amino acids numbered 421-433 in gp120 can serve as the Achilles heel of HIV. “Unlike the changeable regions of its envelope, this region must remain constant to attach to T cells. Equally important, HIV can survive only if the body’s immune system fails to produce antibodies to this region. The virus minimizes production of antibodies to the vulnerable region because it also silences B lymphocytes, the cells responsible for producing antibodies,” Paul said. “In nature, microbial antigens stimulate antibody synthesis when they bind antibodies on the surface of B cells by weak noncovalent forces. In the case of HIV, noncovalent binding of its cell attachment site induces a state of B cell tolerance, permitting infection to proceed unchecked. Our covalent vaccination approach breaks the tolerance and stimulates production of antibodies that inactivate the virus.”

The tolerance signal is converted to a stimulatory signal because strong covalent binding to the B cells liberates a large amount of energy that is not available in traditional binding reactions, Paul said. Moreover, the prototype vaccine contains two modular antigenic regions. Binding of one region generates a stimulatory signal that overcomes the tolerance signal.

“There is another advantage. B cells have the unique capability of producing antibodies adapted to recognize the chemical groups we placed in the prototype vaccine. The adaptations impart enzyme-like activity to the antibodies, which results in exceptionally stable HIV binding, and sometimes, in catalytic breakdown of the viral coat. Consequently, the antibodies inactivate HIV effectively,” Paul said.

“The failure of previous HIV vaccine trials has produced pessimism about the prospect of effective HIV vaccination. Our approach is promising but additional studies are necessary. To expedite development of the vaccine, we must maximize the antibody response and focus it even more at the HIV cellular attachment site,” said Yasuhiro Nishiyama, Ph.D., lead author and an associate professor at UT Medical School.

“While the prototype vaccine induces antibodies that neutralize infection of isolated human cells, we must also show that the antibodies prevent the natural process of infection within the body,” said Stephanie Planque, Ph.D., co-author and researcher in Paul’s laboratory.

“The induction of antibodies that neutralize infection of human blood cells by diverse strains of HIV from various parts of the world is an important milestone. This is an entirely new vaccination approach that might bypass the natural constraints on developing effective immunity against HIV,” said Carl Hanson, Ph.D., study co-author and head of the Retrovir us Diagnostic Section of the Viral and Rickettsial Disease Laboratory of the California Department of Public Health.

Others contributors in the study from the Department of Pathology and Laboratory Medicine at the UT Medical School, were: Yukie Mitsuda, Ph.D.; Giovanni Nitti; Hiroaki Taguchi, Ph.D.; Lei Jin, Ph.D.; Jindrich Symersky, Ph.D.; Stephane Boivin, Ph.D.; and Marcin Sienczyk, Ph.D. Maria Salas of the Viral and Rickettsial Disease Laboratory also contributed to the study.

The journal article is titled “Towards Effective HIV Vaccination: Induction of Binary Epitope Reactive Antibodies with Broad HIV Neutralizing Activity.” The research was funded by the National Institutes of Health and the Texas Higher Education Coordinating Board.

Source:
Robert Cahill

University of Texas Health Science Center at Houston

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced that the US Food and Drug Administration (FDA) has reviewed and accepted an Investigational New Drug (IND) application to initiate an open-label, repeat-dosing Phase 1 clinical trial (SB-728-T-902) of the company’s ZFN-based therapeutic, SB-728-T. A single dose Phase 1 clinical study of SB-728-T was initiated in February 2009 and is ongoing at the University of Pennsylvania. Both Phase 1 studies are designed primarily to evaluate the safety and tolerability of this ZFP Therapeutic(TM) approach, however subjects’ CD4 T-cell counts, levels of CCR5-modified T-cells and viral burden will also be monitored.

“Opening a second Phase 1 clinical trial of this exciting new approach to HIV/AIDS treatment enables us to expedite clinical and commercial development of SB-728-T. We are very pleased with the FDA’s decision enabling us to expand this program and move forward quickly with a repeat-dosing trial,” said Dale Ando, M.D., Sangamo’s chief medical officer and vice president of therapeutic development.

“The best approach to controlling HIV is by preventing infection of cells in the first place. Since 1996, when CCR5 was validated as a target for HIV therapy, the goal has been to recapitulate the naturally-occurring protection against viral infection exhibited by individuals who have the CCR5-delta32 mutation. We have the ability to disrupt the CCR5 gene and make human T-cells resistant to infection by CCR5-specific strains of HIV. In this trial we will be evaluating SB-728-T in subjects that have well-controlled levels of virus but have sub-optimal recovery of CD-4+ T-cell counts despite long-term triple drug therapy. This group represents approximately thirty percent of all HIV-infected patients in the US and may particularly benefit from this novel T-cell ZFP Therapeutic approach.”

Based on Sangamo’s zinc finger DNA-binding protein nuclease (ZFN) technology, SB-728-T has been shown in an animal model of HIV infection to lead to an increase in CD4+ T-cell counts, a reduction in viral load and expansion of CCR5-modified T-cells, suggesting resistance to HIV.

“Although it is still early days, we are encouraged by what we have seen in pre-clinical experiments and in the ongoing Phase 1 clinical trial that is being run by collaborators at the University of Pennsylvania,” commented Edward Lanphier, Sangamo’s president and CEO. “This new study is another important step in our mission to establish ZFP Therapeutics as a major new therapeutic product development platform. Moving our first ZFN technology-based product efficiently through the development process is vital to that goal. SB-728-T represents a new treatment paradigm for the treatment of HIV and we are very excited to expand its clinical development.”

CCR5 is a co-receptor that enables HIV to enter and infect cells of the immune system. It has been observed that individuals carrying a natural mutation of their CCR5 gene, CCR5-delta32, are highly resistant to infection by HIV, despite high-risk behaviors. These individuals, lacking a functional CCR5 (approximately 1-2% of the general population), are otherwise immunologically “normal”. A variety of small molecule and antibody antagonists of CCR5 binding have been tested and developed as potential therapeutic agents for the treatment of HIV infection. In addition, there is a recent report of a patient who had both HIV infection and leukemia and received a bone marrow transplant from a donor carrying the CCR5 mutation. After the successful bone marrow transplant, HIV treatment was discontinued and the virus could not be found in the circulating blood several months after the procedure. Sangamo’s ZFNs are designed to modify the DNA sequence encoding CCR5. This modification can occur directly in T-cells with only a brief exposure to the ZFNs. Once the modification is made to the T-cell’s CCR5 gene it is permanently disrupted.

About the SB-728-T Clinical Trial (SB-728-T-902)

The study is an open-label Phase 1 clinical trial to evaluate the safety and tolerability of repeat infusions of autologous (a patient’s own) CD4+ T cells genetically modified at the CCR5 gene by CCR5-specific ZFNs (SB-728-T). The trial will enroll a total of nine HIV infected subjects on long-term, stable anti-retroviral therapy whose virus is undetectable in their blood by conventional methods but who have exhibited suboptimal CD4+ T-cell gains. The trial will have three dosing cohorts. The first cohort to be treated will receive a single dose, the second cohort, two doses at fourteen day intervals and the third cohort, three doses at fourteen day intervals. The subjects in each cohort will be treated sequentially and monitored for 2 months after their last treatment before an additional subject is treated. After this period of evaluation and monitoring has passed successfully, the next cohort will be treated, again sequentially. Subjects will remain on their existing antiviral therapy while receiving treatment with SB-728-T. The primary objective of the study is to evaluate the safety and tolerability of SB-728-T. In addition to safety monitoring, data will be collected on the expansion and persistence of ZFN-modified cells, CD4+ cell counts and viral load.

Preclinical Data

Preclinical data on SB-728-T were published in the journal Nature Biotechnology (Perez E. E. et al., Nat Biotechnol. 2008 Jul; 26(7):808-16.) and presented at the joint meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA) in Washington, DC in October 2008. The results demonstrate that a one-time exposure to CCR5-specific ZFNs resulted in the generation of an HIV-resistant population of human primary T-cells by the permanent genetic modification of the CCR5 gene. These ZFN-modified CD4 T-cells expanded stably in HIV-infected cultures for several weeks and behaved identically to untreated T-cells except that they were resistant to infection by HIV. ZFN treated primary CD4 T-cells and transformed CD4 cell lines resisted infection with R5-tropic HIV (virus that uses the CCR5 co-receptor to enter cells), resulting in enrichment of ZFN-generated CCR5-disrupted cells in the population upon long-term exposure to virus (>50 days). Importantly, in the presence of HIV, ZFN-modified CD4 T-cells also preferentially expanded in a mouse model. The modified cells were infused into mice that lack a normal immune system and thus do not reject human cells. After 33 days, the mice were sacrificed and analyzed for the presence of ZFN-modified cells. Researchers determined that ZFN-modified cells engrafted normally in the mouse and that the proportion of modified cells present at the end of the experiment was greater than two to three fold higher in mice in the presence of HIV infection (p=0.008). In additional experiments, it was determined that 50 days after infection, mice given the ZFN-modified cells had increased numbers of CD4 cells and a statistically significant reduction in viral load in their peripheral blood (P<0.001) compared to mice given control cells. These data suggest that, in the presence of HIV, the ZFN-modified cells have a selective advantage allowing them to evade infection and destruction.

About HIV/AIDS and CCR5

HIV stands for Human Immunodeficiency Virus. HIV infection kills or impairs cells of the immune system progressively destroying the body’s ability to fight infections and certain AIDS (Acquired Immune Deficiency Syndrome). Individuals diagnosed with AIDS are susceptible to life-threatening diseases called opportunistic infections, which are caused by microbes that usually do not cause illness in healthy individuals. According to UNAIDS/WHO, over 2.7 million people were infected with HIV in 2007. There are now over 33 million people living with HIV and AIDS worldwide.

About Sangamo

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development program is currently in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic neuropathy and ALS. Sangamo also has a Phase 1 clinical trial to evaluate safety and clinical effect of a ZFP Therapeutic approach for the treatment of HIV/AIDS. Other therapeutic development programs are focused on cancer, neuropathic pain, nerve regeneration, Parkinson’s disease and monogenic diseases. Sangamo’s core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN) for gene modification. Sangamo has established strategic partnerships with companies in non-therapeutic applications of its technology including Dow AgroSciences, Sigma-Aldrich Corporation and several companies applying its ZFP technology to engineer cell lines for the production of protein pharmaceuticals.

This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, references to clinical trials of SB-728-T, the potential for further study and development of SB-728-T for the treatment of HIV/AIDS, the research and development of novel ZFP TFs and ZFNs as ZFP Therapeutics, applications of Sangamo’s ZFP TF technology platform, strategic partnerships with collaborators and clinical trials of ZFP Therapeutics. Actual results may differ materially from these forward-looking statements due to a number of factors, including but not limited to, technological challenges, uncertainties relating to the initiation and completion of stages of ZFP Therapeutic clinical trials for Sangamo’s HIV/AIDS therapeutic development program, Sangamo’s ability to develop commercially viable products and technological developments by our competitors. See Sangamo’s SEC filings, and in particular, the risk factors described in Sangamo’s Annual Report on Form 10-K and its most recent quarterly report on Form 10-Q. Sangamo assumes no obligation to update the forward-looking information contained in this press release.

Source: Sangamo BioSciences, Inc