Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Wednesday September 23, 1998
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 clinical trials 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.
HE2000 has a new mechanism of action to inhibit HIV replication by manipulating host cellular factors. Preclinical in vitro testing of the drug has demonstrated significant efficacy by inhibiting various strains of HIV including wild type, reverse transcriptase inhibitor (RTI) resistant and multiple drug resistant isolates (strains). In vivo (animal) toxicity studies with acute dosing regimens of the compound have indicated no toxicity at up to 100 times the expected human dose. Because HE2000 does not target specific viral proteins, Hollis-Eden believes it may be a more durable treatment and less prone to viral mutations and the resulting resistance to drug therapy.
"Our therapeutic approach is to develop new classes of drugs to inhibit HIV replication by treating the host rather than trying to block a constantly mutating virus. Preclinical studies have substantiated the importance of studying this approach in patients," said James Frincke, Ph.D., Vice President of Research and Development, Hollis-Eden Pharmaceuticals.
The current recommended standard of care for anti-HIV drug therapy consists of combinations of drugs such as RTI and protease inhibitors (PI) that inhibit HIV replication by blocking specific viral proteins. The major issue associated with utilizing the RTI/ PI therapy is the virus' ability to mutate and change its structure to one that is resistant to these drug combinations. At the 12th World AIDS Conference in Geneva, it was reported in studies that up to 54% of patients currently taking these anti-HIV drug combinations had developed resistance to the drugs and were failing therapy. Additional issues of current HIV drug therapies are high cost, short and long-term side effects and the strict adherence regimen required for efficacy. These issues also have made it difficult for developing countries to implement current anti-HIV drug therapies.
Hollis-Eden Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the development and commercialization of products for the treatment of infectious diseases and immune system disorders. For more information about Hollis-Eden Pharmaceuticals, contact their web site at http://www.holliseden.com.
Statements made in this press release may constitute forward-looking statements and are subject to numerous risks and uncertainties, including the failure to successfully complete pivotal clinical trials, the Company's future capital needs, the Company's ability to obtain additional funding and required regulatory approvals, the development of competitive products by other companies, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. The actual results may differ materially from those contained in this press release.
SOURCE: Hollis-Eden Pharmaceuticals, Inc.
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