Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : IMNR - Immune Response -- Ignore unavailable to you. Want to Upgrade?

To: Alex Glavinos who wrote (1356)	5/17/1999 3:38:00 PM
From: margie	Read Replies (2) \| Respond to of 1510

This original Remune study was planned in 1996, the year that the first protease inhibitors were approved by the FDA. The efficacy of HAART was underestimated. The number of patients electing to receive HAART in the study, once the trial had begun, was also underestimated. The results are not surprising, as meaningful differences using the clinical endpoints of progression to AIDS or the development of opportunistic infections would be unlikely on HAART, so one would not expect them on HAART plus Remune either. One of the announcements of this study in 1996. aegis.com "Technology & Health: Immune Response Launches Big Study Of Its Experimental AIDS Treatment. WSJ 18 March 1996 " by Rhonda L. Rundle. From the article above: <The test is expected to determine once and for all whether the therapy, called Remune, delays the onset of AIDS in HIV-infected people. The trial is also unusual because it allows participants to continue taking their current medicines, including any of the three new AIDS drugs just approved by the U.S. > The lack of significant differences are more of a testament to the efficacy of HAART, unknown at the time; and do not indicate that Remune is ineffective. One would not expect many patients on HAART to progress to AIDS. Virological difference alone might not differentiate the two groups either; if less sensitive assays were used; such as <500 or <400 copies, and the assays are not specified. Agouron has said from the beginning of the relationship with Immune Response, that they wanted to do a study on surrogate markers. I guess I also read too much significance into the announcement between Gallo and IMNR. IMNR agreed to license of Gallo's HAF and IMNR will be conducting trials or research at the Institute of Human Virology. For some reason, I thought that indicated positive results from the DSMB. Obviously I was wrong about that.. Immune Response is still waiting for a decision from the Thai government on Remune approval.. I believe the only trials halted were those that began in in US medical centers in 1996, with 2500 patients. As far as I know, the more recent trials are still ongoing or will be started as planned. There is a double blind placebo controlled one year trial; using Remune and/or HAART; started June '98, at Mass General, with Dr. Bruce Walker. (IRC press release 6/17/98). -Agouron and Immune Response plan a rollover study using these patients, discontinuing HAART and using Remune to maintain viral load suppression. -There is an ongoing pediatric trial at the NIH in phase I. -There is a clinical trial ongoing with Remune ongoing in Spain. -There is a clinical trial in Switzerland, under the direction of Dr. Pantaleo, started January '98; with Roche and Glaxo. -Jay Levy, from UCSF will be starting a study of Remune after one year on HAART. Immune Response is hoping that Remune will be approved soon in Thailand.