CytRx Corporation, 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 National Institutes of Health, has been designated an investigational new drug by the US 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, M.D., Ph.D., 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."

Dr. 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.

So far, the DNA and protein combination has been tested in two animal models with very promising results. Antibodies produced by the immunized animals effectively neutralized live HIV isolates collected from several parts of the world. That success facilitated taking the novel vaccine to the next step, a clinical trial in humans. "There is no live HIV in the vaccine, only elements from the DNA that code for the envelope and gag proteins of the virus, so there is no chance of getting HIV from this vaccine," Dr. Lu said.

The new HIV vaccine incorporates DNA and protein-proprietary technology exclusively licensed to CytRx by UMMS and ABL. The HIV Vaccine project has been funded, to date, under a 5-year HIV Vaccine Design & Development Teams contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The funds under this program, totaling approximately $16 million, are expected to provide all of the needed funding for the Phase I trial.