FOR IMMEDIATE RELEASE: MARCH 14, 2002
Contact: Gwen Fariss Newman ([email protected]) 410-706-4616
INSTITUTE OF HUMAN VIROLOGY OPENS TWO INNOVATIVE CLINICAL TRIALS FOR THERAPEUTIC COMPOUNDSBoth utilize basic science findings that are products of IHV
BALTIMORE, MD - The Institute of Human Virology (IHV), a center of the University of Maryland Biotechnology Institute led by internationally renowned Robert Gallo, M.D., this month opens two innovative clinical trials, one utilizing a pharmaceutically-produced compound based on a naturally-occurring substance (called chemokines) that can block the HIV virus and halt the progression of AIDS, a Gallo discovery that was hailed by Science magazine in 1996 as one of that year's most important scientific breakthroughs.
The Schering-Plough Research Institute is the first to synthetically reproduce this compound (called SCH-C) -- part of a new class of HIV therapies called entry inhibitors -- and the Institute of Human Virology is one of three centers nationwide to offer the experimental drug to HIV patients.
The IHV also is the first -- and only -- institute in the United States to move forward with a therapeutic AIDS vaccine developed by Aventis Pasteur and designed to target and block the biological activity of tat, a protein that is essential for the replication of the HIV virus and ultimate infection.
Both clinical trials incorporate basic science findings credited to Dr. Gallo and the Institute and also exemplify the IHV's mission to hasten scientific progress from bench to bedside, from laboratory setting to actual patient care.
"The Institute, which opened just five years ago, is the first research center in the U.S. structured to integrate in a single center basic, population and clinical research efforts to streamline the scientific process in hopes of creating preventative and therapeutic vaccines to halt the AIDS epidemic," says Dr. Gallo.
A flurry of AIDS scientific discoveries occurred in 1996, beginning with Gallo's discovery of three chemokines (RANTES, MIP-1 alpha and MIP-1 beta), highly potent compounds produced naturally in the body that stimulate the immune system and are powerful HIV blockers.
The discovery of chemokines was followed by an announcement by the National Institute of Allergy and Infectious Disease's Dr. Edward Berger that HIV needs not one but two proteins to gain a foothold in the human body, quickly followed by the identity of a co-receptor known as CCR-5 that helps HIV cells gain entry to replicate and infect. More interesting still was that 1 percent of Caucasians lack the gene needed to make this receptor and that they are virtually immune to the HIV virus despite the fact that they possess CD4, the only receptor known to scientists for 12 years prior.
It was this combination of scientific findings - and a better understanding of how the HIV virus gains entry into cells -- that makes the Schering-Plough compound so exciting and set the wheels in motion for the pharmaceutical industry to pinpoint a potential new "target" for future drugs.
"An underlying research emphasis at IHV is to use the body's natural ability to fend off infection and heal itself and to discover and utilize biological approaches to therapy and treatment that may be less toxic - and less costly -- than drugs currently on the market," explains Dr. Robert Redfield, director of the IHVs Division of Clinical Care and Research. "Schering-Plough has built upon these landmark discoveries to create a chemokine antagonist that blocks key receptors - or entry points of the virus. It's a new approach designed to actually block the HIV virus from getting into cells in the first place."
Unlike existing HIV drugs that work inside the cell and target viral enzymes involved in the replication of the virus, entry inhibitors work by blocking HIV before the virus enters the cell and begins its replication process.
IHV will recruit up to16 volunteers to participate in a 28-day Phase I clinical trial of SCH-C, to be taken orally twice daily for 10 days. Participants will be hospitalized at the University of Maryland Medical Center for 12 days and will closely monitored. The purpose of a Phase I study is to evaluate the safety, tolerability and possible antiviral effects of the experimental compound.
"Preliminary results have been very promising; this is an exciting area of clinical research," says Dr. Redfield. "This new class of medication represents the first alternative treatment option AIDS scientists have seen since the introduction of protease inhibitors in 1996. The creation of chemokine antagonists represents a major milestone in potential treatment and preventive approaches, though we have years of research ahead to explore its full potential."
Meanwhile, the Institute's Tat therapeutic vaccine clinical trial utilizes an inactivated form of the protein (Tat toxoid) to induce antibodies against Tat. Tat is a protein made by the HIV virus and is essential for the replication of HIV. Tat also can be released from infected cells and can act directly on the body's killer T-cells that fight infection, causing them to become inert and leading to their inability to proliferate, thus diminishing the body's immune response against HIV.
It's also been noted that HIV patients who have gone long-term, perhaps for 20 years, without progressing to symptomatic disease often have high levels of Tat antibodies, leading scientists to believe that being able to induce Tat antibodies may result in more and more patients being long-term non-progressors who can live with the HIV virus without succumbing to AIDS.
"We've come to believe that targeting Tat may be an additional arm in the fight against HIV," says Dr. Gallo, "particularly a therapeutic vaccine approach which should be safe, simple and cost effective and potentially applicable for use in developing countries where the AIDS epidemic is at its strongest."
The tat toxoid vaccine is based on research concepts developed by Dr. Daniel Zagury in Paris in collaboration with Dr. Gallo and has been developed by Aventis Pasteur, a worldwide vaccine company and component of Aventis.
The Institute will be recruiting 32 participants for a five-month study evaluating the safety and immunogenicity of the tat taxoid vaccine, which will be delivered in a series of intramuscular injections into the shoulder.
Participants will already be on antiretroviral therapy, which will continue simultaneously throughout the clinical trial, must have a non-detectable viral load and CD4 cell counts greater than 300.
"Because our ultimate goal is to develop a less costly vaccine that can be more readily available for AIDS treatment and prevention efforts worldwide, this is one of several vaccines under study at the Institute," adds Dr. Gallo. "We are very excited about the progression of both of these scientific advancements into the clinic and are delighted that our early research helped form the basis for these novel approaches."
The Institute of Human Virology was established to create and develop a world-class center of excellence focusing on chronic viral diseases and virally linked cancers. The IHV is dedicated to discovery, research, treatment and prevention of these diseases and cancers. Its unique structure seeks to connect cohesive, multidisciplinary research and clinical programs so that new treatments are streamlined from discovery to patient. The IHV serves patients locally and the scientific community globally.
For more information, call 410-706-2784.
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