VoyForums
[ Show ]
Support VoyForums
[ Shrink ]
VoyForums Announcement: Programming and providing support for this service has been a labor of love since 1997. We are one of the few services online who values our users' privacy, and have never sold your information. We have even fought hard to defend your privacy in legal cases; however, we've done it with almost no financial support -- paying out of pocket to continue providing the service. Due to the issues imposed on us by advertisers, we also stopped hosting most ads on the forums many years ago. We hope you appreciate our efforts.

Show your support by donating any amount. (Note: We are still technically a for-profit company, so your contribution is not tax-deductible.) PayPal Acct: Feedback:

Donate to VoyForums (PayPal):

[ Login ] [ Contact Forum Admin ] [ Main index ] [ Post a new message ] [ Search | Check update time | Archives: 1, 2, [3], 4 ]

[ Next Thread | Previous Thread | Next Message | Previous Message ]

Date Posted: 18:56:43 07/24/02 Wed
Author: moonotter
Subject: Hollis-Eden Says HIV Drug Shows Viral Load Reduction in Phase II Trial

Hollis-Eden Says HIV Drug Shows Viral Load Reduction in Phase II Trial


Reuters Health Information 2002. © 2002 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.


NEW YORK (Reuters Health) Jul 08 - Hollis-Eden Pharmaceuticals Inc. on Monday said that one dosing group in a phase II trial of its investigational HIV drug, HE2000, exhibited a statistically significant downward slope in viral load, according to a preliminary analysis of the clinical data.
Hollis-Eden presented the data Monday at the International AIDS conference in Barcelona, Spain.

The company is developing HE2000, an immune-regulating hormone, with the goal of using the drug to delay the progression of HIV to AIDS. A drug such as HE2000 would support the new National Institutes of Health (NIH) recommendation to delay initiation of antiretroviral treatment until HIV has significantly progressed towards AIDS, to help reduce the long-term side effects and emergence of viral resistance to HAART, according to Hollis-Eden.

The 24 treatment-na ve subjects in the South Africa-based trial received three cycles of daily subcutaneous injections of either a 50-mg or 100-mg dose of HE2000, or placebo, for five consecutive days every six weeks, and were followed for an additional 12 weeks after the last dosing cycle.

In the 50-mg dose group, investigators observed a statistically significant downward slope in viral load versus placebo during the study period, and the maximum viral load reduction from baseline (0.66 log) at the end of the 30-week study, according to Hollis-Eden.

Patients in the 100-mg arm likewise experienced a downward slope in viral load, but the decline achieved was not statistically significant. A maximum viral load reduction (0.45 log) was observed in the group treated with a 100-mg dose of HE2000.

Hollis-Eden said HE2000-treated patients exhibited statistically significant increases in several cell types associated with innate and adaptive cell-mediated immunity during the study. These cell types include killer cells, dendritic cells and Th1 cells. Investigators noted that these types of cells in the six-patient placebo group generally declined during the course of the study.

"It is very encouraging to...[observe] that the trend line for viral load continued to decline over the course of the eight-month study," said Hollis-Eden Medical Director Dr. Dwight Stickney, in a statement. "This viral load reduction is significant because it demonstrates immunologic control of HIV replication versus a direct antiviral mechanism, particularly given that HE2000 was administered as a single agent on an intermittent basis rather than as part of a drug cocktail given daily."

Investigators observed no serious drug-related adverse events, according to the company. The most commonly reported side effect was mild to moderate reaction at the site of the injection.

Hollis-Eden said it has treated more than 150 patients with HE2000 in phase I/II and phase II clinical trials.



--------------------------------------------------------------------------------

[ Next Thread | Previous Thread | Next Message | Previous Message ]

[ Contact Forum Admin ]

Forum timezone: GMT-6
VF Version: 3.00b, ConfDB:
Before posting please read our privacy policy.
VoyForums(tm) is a Free Service from Voyager Info-Systems.
Copyright © 1998-2019 Voyager Info-Systems. All Rights Reserved.