Dr. Leslie Z. Benet, an internationally recognized drug development expert and one of the most highly cited pharmacologists in the world, has joined the advisors of Viral Genetics.
CEO, Viral Genetics, Haig Keledjian said: “To have an advisor of Dr. Leslie Benet's stature in drug development join our company, is in keeping with our current goal of bringing on best-in-class advisors in their field to spearhead the development of the targeted peptide therapies forward.”
Dr. Benet joins a current team of esteemed advisors with diverse expertise to help guide Viral Genetics as it develops unique therapies for HIV and other diseases of the immune system.
Dr. Benet, who will advise on all drug development, said:
“I am highly intrigued and very excited by the recent groundbreaking work carried out by Dr. M. Karen Newell and Viral Genetics to explain the mechanism of action by which TNP in past trials causes plasma viral load to decrease in some patients, but not others. I believe that unraveling this mechanism gives Viral Genetics the opportunity to optimize treatment and practice the ultimate in personalized medicine by designing genetic specific therapies for HIV/AIDS as well as other immune diseases. I look forward to contributing my expertise in personalized metabolic and transport properties and in drug development to facilitate approval of these new therapeutics and their use in saving patient lives.”
Based on new information from ongoing AIDS and lyme disease studies being led by head of research Dr. M. Karen Newell, PhD, new components of the mechanism of TNP, the company's drug compound, have been identified.
SVP of Corporate Development and Communications Monica Ord stated: “Dr. Benet's expertise and direction in drug development are of paramount importance as we move forward with the IND process. He is not only one of the most cited pharmacologists in the world but his international recognition includes work with top Pharmaceutical companies, Merck, Boehringer Ingelheim, Amgen, Schering Plough, and many others. We could not be more delighted and honored to have him on board with us.”
Dr. Benet, Professor and former chairman (1978-1998), Department of Biopharmaceutical Sciences, University of California, San Francisco (UCSF) has received international recognition for his work related to pharmacokinetics and pharmacodynamics-the processes by which the human body absorbs and eliminates drugs and the pharmacologic effects observed from those drugs. He is the recipient of six honorary doctorates, membership in the Institute of Medicine (IOM) of the U.S. National Academy of Sciences, listed among the most highly cited pharmacologists worldwide and recognized with the highest scientific awards of nine professional societies, including the Distinguished Pharmaceutical Scientist award of the American Association of Pharmaceutical Scientists, the Rawls-Palmer Progress in Medicine award of the American Society for Pharmacology and Therapeutics, the Higuchi research Prize of the American Pharmacists Association and the Host-Madsen Medal of the International Pharmaceutical Federation (FIP). In 2007 he was selected as the UCSF Distinguished Clinical Research Lecturer. Dr. Benet formerly served as Chair of the Pharmacology Study Section and the Pharmacological Sciences Review Committee for the NIH, the FDA Center for Biologics (CBER) Peer Review Committee, the FDA Expert Panel on Individual Bioequivalence, the Board of Pharmaceutical Sciences of the FIP, the Organizing Committee for the Millenial World Congress of Pharmaceutical Sciences, the Congressionally mandated IOM/NRC Committee on Accelerating the Research, Development and Acquisition of Medical Countermeasures Against Biological Warfare Agents and as a member of the FDA Generic Drugs Advisory Committee and the FDA Science Board. He served as the Chair of the CBER subcommittee of the FDA Science Board that delivered its review of science at the FDA in December 2007. He was the Founder and first President of the American Association of Pharmaceutical Scientists that now numbers more than 13,000 members. Dr. Benet’s research interests and more than 490 scientific publications, 7 books and 11 patents are in the areas of pharmacokinetics, biopharmaceutics, drug delivery and pharmacodynamics.
Viral Genetics continues to study TNP, a mixture of peptides, originally derived from thymic histones, to research HIV/AIDS. The results of six international human clinical trials of a TNP-based drug showed reduced viral load and clinical improvement. During subsequent in vitro and in vivo research, the study group found that individual peptides in the TNP mixture can bind to antigen-presenting cells and may be able to redirect the immune response.
The study group has discovered, and will continue to look for, peptides that will bind with high affinity to the greatest number of molecules encoded by MHC alleles (genes) within a population. The MHC genes encode molecules that are expressed on antigen-presenting cells. The group has finished preliminary studies, and is currently testing candidate peptides in a number of in vitro and in vivo models that it believes will provide proof-of-concept studies for both HIV as well as other diseases.
To uncover the mechanism of action responsible for improvement in previous international clinical trials of TNP, the active components had to be identified and synthesized to purity. The purified peptides then had to be, and will continue to be, tested for activity, safety and efficacy. As a result, Viral Genetics has uncovered evidence for a likely mechanism of action using its targeted peptide approach. The goal of the studies is to obtain an Investigational New Drug application for testing the newly identified and synthesized peptides that can appropriately redirect the immune response to HIV.
About Viral Genetics
Viral Genetics, Inc. is a biotechnology company that discovers and develops immune-based therapies for HIV and AIDS using its thymus nuclear protein compound (TNP). The company recently entered into an Exclusive License Agreement with the University of Colorado and V-Clip Pharmaceuticals (a subsidiary of the Company) to license technology developed by M. Karen Newell, PhD that appears to explain TNP and provide a means to optimize therapies based on TNP for future clinical trials. TNP may have other potential applications for other infectious, autoimmune, and immunological deficiency diseases that the company intends to study in the future. Viral Genetics believes that its investigational HIV/AIDS drug based on TNP, called VGV-1, represents a unique approach to treating HIV due to the apparently novel mechanism, low toxicity profile, simple dosing regimen, and short-course of treatment. As a type of immune-based therapy, it focuses on boosting the immune system to allow the body to fight HIV more efficiently. VGV-1 has been studied in five human clinical trials for the treatment of HIV/AIDS. Online at www.viralgenetics.com.
This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Viral Genetics, Inc. from time to time in its periodic reports filed with the SEC. VGV-1 is not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world. While Viral Genetics believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Viral Genetics to establish the efficacy of VGV-1 in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of VGV-1 in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the forward-looking statements should not be regarded as a representation by Viral Genetics or any other person that the objectives and plans of Viral Genetics will be achieved.
Contacts:
Haig Keledjian, 626-334-5310
