FDA accepts IND for unique HIV vaccine.

2004 APR 21 - (NewsRx.com & NewsRx.net) -- CytRx Corporation (CYTR), Advanced BioScience Laboratories (ABL) and the University of Massachusetts Medical School (UMMS) announced that the HIV vaccine formulation developed by the University of Massachusetts Medical School and ABL and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, has been designated an investigational new drug (IND) by the U.S. Food and Drug Administration.

By allowing the IND to go into effect, the FDA has cleared the way for UMMS to begin a clinical trial to test the safety and immunogenicity of the vaccine.

"This vaccine represents a novel approach to HIV vaccine development, and we are excited to contribute to the effort to fight the worldwide HIV epidemic," said Steven A. Kriegsman, president and CEO of CytRx.

UMMS will conduct the phase I clinical trial and begin recruiting patients shortly. The phase I trial will involve 36 people and is expected to last 12-18 months. The study is to be initiated in Worcester, Massachusetts.

"This is a landmark development and a major step forward in HIV vaccine research," said Shan Lu, MD, PhD, associate professor of medicine and head of the HIV vaccine effort at UMMS. "Our vaccine is based on elements from primary virus isolates drawn from all over the world, and that, I think, will make a difference in the efficacy of the vaccine."

Phillip Markham, director of Cell Biology and principal investigator of the ABL/UMMS HIV Vaccine Development and Design contract team agrees that this is a very promising vaccine approach which should address certain shortcomings observed in previous trials.

HIV, the virus that leads to acquired immune deficiency syndrome (AIDS), remains a global epidemic. World health officials estimate 42 million people are now infected with HIV. Some 3 million people died of AIDS last year, worldwide, and millions more are expected to die from AIDS this year. With the rate of infection accelerating in many parts of the world, the search for an effective HIV vaccine is one of the highest public health priorities. Yet, development of an HIV vaccine has been challenging because of the virus' extraordinary degree of genetic diversity.