Advanced Biotherapy Responds to Emergence of HIV Drug Resistance Emphasizing Its Clinical Research of an Immune Based Approach to Treating HIV

WOODLAND HILLS, Calif. -- Advanced Biotherapy, Inc., dedicated to pioneering the development and use of therapeutic antibodies, responds to breaking news regarding a recently discovered new resistant strain of the HIV virus that was detected in New York City, as reported by CBS affiliate WCBS-TV New York on February 11, 2005 -- "Health officials warn that a rare strain of the HIV virus has reached New York City -- new strain does not respond to common treatments." According to the city's health commissioner, Dr. Thomas Frieden, the patient who contracted this virus was determined to be resistant to 19 of the 20 FDA-approved anti-retroviral drugs.

Edmond Buccellato, CEO of Advanced Biotherapy, states, "HIV's usual course of progression to the development of AIDS is known to normally take several years, often upwards of 10 years. In the case of this newly discovered strain, three months after HIV diagnosis the individual had progressed to AIDS. Experts caution that the spread of this deadly strain may have been expedited by the rapid disease progression and greater infectivity of this particular strain. With the increasing incidence of multi-class drug resistance, it is our opinion that our approach to controlling HIV infection by augmenting the immune system responses will be successful."

Dr. Bellanti, the principal investigator of the Georgetown FDA-approved phase I clinical trial, states, "The greatest challenge faced by HIV-treating clinicians has been the management of virologic failure and metabolic complications of anti-HIV treatment. The recent emergence of this highly drug-resistant HIV strain not only highlights this challenge but also stresses the need to seek new alternative treatment measures. Our study is directed to determine the clinical effectiveness of inhibiting tumor necrosis factor-alpha (TNF-alpha) in HIV-infected subjects who have received prior antiretroviral treatment with standard therapy and who have failed to respond. We have begun the study and hope to report encouraging results in the near future."

While normal production of the key TNF-alpha cytokine helps the immune system fight disease, its overproduction has the contrary effect of promoting not only greater viral replication in AIDS patients, but also a number of mental and physical disorders associated with immune system breakdown. A complex cellular relationship referred to as the cytokine "network" or "cascade" is responsible for helping the immune system communicate and direct responses against viruses, bacteria, fungi and tumors. HIV appears to disrupt the normal balance of this network. Restoring the functioning of this network may improve the ability of a patient's immune system to fight the AIDS virus.

Source: Advanced Biotherapy