SAN FRANCISCO -- Viral Technologies Inc. announced that itbegan on Wednesday Phase I clinical trials of its core proteinAIDS vaccine with the injection of a healthy volunteer at SanFrancisco General Hospital.
This is the first U.S. clinical trial of VTI's HGP-30 vaccine, whichhas already undergone safety trials in London. The U.S. trials,scheduled to last one year, will involve 24 healthy volunteerswho test negative for the HIV virus. The trials test for toxicityand adverse side effects.
By focusing on the HIV core protein, VTI has broken awayfrom the pack of companies working to develop an AIDSvaccine.
"Three or four years ago we were really on the fringe," saidAllan Goldstein, founder and chief science adviser to Alpha 1Biomedicals Inc., based in Washington, D.C. "Now almosteveryone recognizes that the core is going to have to be part ofthe equation, if not the key part."
VTI, also based in Washington, is a joint venture betweenAlpha 1 (NASDAQ:ALBM) and Cel-Sci Corp. (NASDAQ:CELI) ofAlexandria, Va.
HGP-30 is a synthetic version of a fragment of the p17 coreprotein of the HIV virus. Most companies are working todevelop vaccines based on viral coat proteins.
"We've identified a highly conserved region of the core proteinthat doesn't mutate," said Goldstein. "We think it will protectagainst the hundreds of variants of the AIDS virus."
The first company to test a true AIDS vaccine wasMicroGeneSys Inc. of West Haven, Conn., which in Januaryreported limited effectiveness of its gp160 coat protein vaccine.
Other companies working on true vaccines include Biocine Co., ajoint venture between Chiron Corp. (NASDAQ:CHIR) ofEmeryville, Calif., and Ciba-Geigy Ltd. of Basel, Switzerland,which hopes to begin clinicals in mid-year. Genentech Inc.(NYSE:GNE) of South San Francisco, Calif., plans Phase I trials atthe same time. Repligen Corp. (NASDAQ:RGEN) of Cambridge,Mass., and its partner, Merck & Co., have a vaccine in animaltrials based on conserved sequences in the V3 loop of the HIVgp120 envelope protein.
Among companies developing therapeutic "vaccines," the mostadvanced is Immunization Products Inc. of San Diego, a jointventure of Immune Response Corp. (NASDAQ:IMNR) and RorerGroup Inc. The company is conducting Phase II/III trials of theinactivated AIDS virus in HIV-positive patients.
Biocine and Genentech are both conducting Phase I clinicalsusing the gp120 envelope protein.
Oncogen of Seattle (now owned by Bristol-Myers Squibb Co.),and Becton Dickinson and Co. of Franklin Lakes, N.J., havedropped work on AIDS vaccines.
VTI plans to begin Phase II trials in London as soon as analysisof the first London trial is complete, said Goldstein, who also ischairman of the Department of Biochemistry and Microbiologyat the George Washington University School of Medicine.
VTI also plans to begin trials this year of HGP-30 as animmunotherapeutic in healthy HIV-positive people. Afterinfection with HIV, one of the first types of immune responselost is to p17, said Goldstein. Boosting that response mighttherefore prevent progression to AIDS.
-- Karen Bernstein BioWorld Staff
(c) 1997 American Health Consultants. All rights reserved.