Investigational new drug application to be filed for HIV vaccine.

2004 JAN 21 - (NewsRx.com & NewsRx.net) -- CytRx Corporation (CYTR) and Advanced BioScience Laboratories (ABL) announced plans for filing of an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for a phase I clinical trial for a new DNA-based HIV vaccine, and a new strategic alliance between the two companies.

The new HIV vaccine incorporates proprietary technology exclusively licensed to CytRx by the University of Massachusetts Medical School (UMMS) and ABL. The HIV Vaccine project has been funded to date in whole by federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health. The funds under this program, totaling approximately $15 million, are expected to provide all of the needed funding for the phase I trial, and UMMS will be primarily responsible for conducting this trial under a subcontract arrangement.

An IND for the phase I trial was expected to be filed with the FDA by January 31, 2004, and CytRx and ABL expect the phase I trial to begin within 30 days after obtaining IND clearance from the FDA. The phase I trial is projected to take approximately 12-18 months to complete.

"There is a worldwide urgent need for an effective HIV vaccine, said Steven A. Kriegsman, CEO of CytRx. "With the anticipated launch of the phase I trial for this vaccine utilizing our licensed UMMS technology, we will take a major step forward in efforts to create such a vaccine. ABL is a well-recognized leader in the fields of HIV research and vaccine technology and CytRx looks forward to working together with ...