Hollis-Eden Pharmaceuticals' Research Affiliate Commences
Phase I/II Clinical Trials with Novel Anti-HIV Drug
PR Newswire - September 23, 1998 13:43
SAN DIEGO, Sept. 23 /PRNewswire/ -- Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH)
announced today that its research affiliate, Edenland, Inc. of Ireland, has commenced two Phase I/II clinical studies with approximately 40 HIV infected treatment naive patients (patients that have not taken any anti-HIV drugs) in South Africa. The studies are testing a novel compound as a monotherapy in dose escalation protocols utilizing two different formulations. The studies are intended to determine the safety and efficacy of this new anti-HIV therapy. The different formulations are intended to evaluate the best route of administration and bioavailability of this drug candidate. This investigational new drug has a novel mechanism of action to inhibit HIV replication. Quintiles Clindepharm, under the medical direction of Dr. Oppel Greeff, and the Medical University of Southern Africa are conducting the studies. The trials are expected to take three months.
Additionally, Hollis-Eden is filing a company-sponsored Phase I/II clinical trial with this novel compound, HE2000, in collaboration with the National Institute of Virology in South Africa. This trial in treatment naive patients is intended to optimize the dosing regimen, safety and efficacy of HE2000. Together Hollis-Eden and Edenland Phase I/II protocols will study this new compound as a monotherapy in more than 80 treatment naive patients. In the United States, the company intends to file an investigational new drug (IND) application with the FDA to initiate Phase I/II clinicaltrials with HE2000 in the fourth quarter.
"With the commencement of our clinical trials, I envision that the day is approaching when a cost-effective monotherapy will challenge the virus successfully. This new therapy not only offers hope to patients in developed countries but also may represent the first effective treatment option for the developing world," said Patrick T. Prendergast, Ph.D., founding scientist, Hollis-Eden Pharmaceuticals and chairman of Edenland Inc.
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They have a website now: holliseden.com
but the links don't seem to work. Is HE2000 just their new name for INACTIVIN and REVERSIONEX. Inactivin is of course their name for DHEA.
Short HEPH from 9/22 at 14 11/16. |
