Immune Response Corp.'s shares rose slightly Monday after the FDAagreed to allow the company to provide its HIV therapeutic vaccine,Remune, to AIDS patients outside the ongoing Phase III trials in theU.S.
Under the expanded access program, the Carlsbad, Calif., companywill make Remune available free of charge to patients through theirdoctors.
The HIV immunogen, which has been in clinical development since1987 and has proved to be safe, is being evaluated in late-stage trialsin the U.S. and Thailand.
A three-year Phase III U.S. study began in March and is expected toenroll 3,000 patients. So far, 1,000 patients have been treated withthe therapeutic vaccine.
Company officials said they sought FDA approval to expand accessto Remune based on demand from patients not eligible for the clinicaltrial. The study targets AIDS patients with CD4 counts between 300and 550. By increasing the availability of Remune, patients with CD4counts less than 300 and greater than 550 also can receive theimmunogen.
Immune Response's stock (NASDAQ:IMNR) closed Monday up$0.062 to $8.187.
Remune, injected once every three months, is designed to stimulate apatient's own immune defenses to fight HIV and is targeted for use inthe early stages of the disease. It also could be taken in combinationwith antiviral drugs, which are administered daily.
Participants in the placebo-controlled clinical studies of Remune willcontinue to receive their nucleoside analogues and proteaseinhibitors, which interrupt viral replication.
Immune Response's HIV immunogen is not a preventive vaccine. Itis inactivated HIV combined with a mineral oil-based adjuvant.Through purification, the killed HIV loses the glycoprotein (gp) 120,which is an envelope protein that helps the virus infect cells.Company officials said loss of gp120 is a benefit, allowing Remuneto stimulate an immune response independent of the surface protein,whose quick mutations enable HIV to avoid attack.
The Phase III U.S. study will test Remune's ability to delayprogression of AIDS and increase patient survival. Data also will becollected on surrogate markers _ increasing CD4 counts anddecreasing viral load _ for research purposes.
Debra Altman, spokeswoman for Immune Response, said an analysisof interim findings from the trial will be conducted by the study'sinvestigators during the third quarter of 1997. If the resultsdemonstrate Remune is effective, the company could use the data toseek marketing approval from the FDA prior to conclusion of thethree-year study.
Immune Response also has reactivated a public offering postponed inAugust during the summer slump in investor interest in biotechnologystocks. The company delayed the equity sale after its shares lost 40percent _ sinking to $7.50 _ in two months following registration ofthe 2.9 million-share offering.
Immune Response officials will complete their road show this weekand expect to price the shares by the end of October.
The company registered to sell 2.5 million shares in June and boostedthe total to 2.9 million shares based on negotiation in July of apotential $50 million gene therapy collaboration with Bayer AG, ofLeverkusen, Germany. As part of the deal, Bayer agreed to purchase$4 million worth of stock in the follow-on offering.
Underwriters for the stock sale are Hanifen Imhoff Inc., of Denver,and Cruttenden Roth Inc., of Irvine, Calif.
In addition to Remune, the company's lead product, and the Bayergene therapy program, which is aimed at blood coagulation disorders,Immune Response is developing other gene therapies for cancer andhas drug candidates in Phase II studies for psoriasis and rheumatoidarthritis. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.