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Hollis-Eden Pharmaceuticals Commencing Phase I/II Clinical Trial With TRIOLEX(TM) (HE3286) in Obese, Insulin Resistant Volunteers

Posted on: Tuesday, 16 October 2007, 09:00 CDT

Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH), the world leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, announced that it is commencing this week a two-stage Phase I/II clinical trial with its oral drug candidate TRIOLEX™ (HE3286) in obese, insulin resistant volunteers. TRIOLEX represents a novel class of insulin sensitizers that the Company believes acts by modulating the anti-inflammatory pathway NF-kappaB. The Phase I/IIa trial is a 28-day study designed to evaluate the safety of the drug candidate and determine the optimal dose for use in a follow-on Phase I/IIb study. A 28-day Phase I/IIb study, currently scheduled to begin in the first half of 2008, will evaluate the effect of TRIOLEX on insulin sensitivity and whole body glucose disposal through euglycemic/hyperinsulinemic clamps, a method widely used in industry and academia to test compounds as potential insulin sensitizers for the treatment of type 2 diabetes.

As reported by Dr. Jaime Flores-Riveros, Hollis-Eden's Vice President of Endocrinology & Metabolism, this week in an oral presentation at the 2nd Annual Metabolic Conference in Boston, Massachusetts, previously released results from the Company's preclinical studies to date suggest that TRIOLEX, a synthetic analog of an endogenous hormone the Company believes may be involved in regulating glucose metabolism, may be the first in a new class of insulin sensitizers with a novel mechanism of action. In the Company's previously reported single-dose Phase I study of TRIOLEX for the treatment of metabolic disorders, the compound was shown to be orally bioavailable in humans, with significant drug concentrations detected in the blood at the lowest dose tested, and all doses of TRIOLEX appeared to be safe and well tolerated in healthy volunteers with no reported drug related adverse side effects to date. In previously reported preclinical models of type 2 diabetes, TRIOLEX produced glucose lowering activity and increased insulin sensitivity. Based on experiments conducted to date to understand its possible mechanism of action, TRIOLEX appears to regulate the pro-inflammatory NF-kappaB pathway without acting on the PPARgamma receptor, which is the target of the currently prescribed glitazone class of insulin sensitizing drugs, such as Avandia and Actos. By not acting on the PPARgamma receptor, TRIOLEX appears in preclinical studies to avoid the undesirable side effect of weight gain associated with existing therapies.

"Advancing TRIOLEX into a Phase I/II human clinical trial is a significant achievement for our development program targeting metabolic disorders," stated Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. "Type 2 diabetes is the epidemic of the 21st Century, and given the side effects associated with currently prescribed insulin sensitizers, there clearly is a need for new therapies that can help diabetes patients more effectively manage their glucose levels. Because TRIOLEX is an analog of a naturally occurring adrenal steroid hormone that we believe may play a role in metabolism, may possess a unique mechanism of action and has demonstrated activity in preclinical models of the disease, we believe the compound, if approved for use, could prove to be an important new class of insulin sensitizers with the potential to be an effective treatment for this chronic, life-threatening disease. TRIOLEX, if successfully developed, could represent a major endocrine-based therapy for regulating insulin sensitivity in type 2 diabetes."

Approximately 20 million Americans and over 190 million people worldwide have type 2 diabetes. As a result of an aging population and a rise in obesity rates, a common risk factor in this disease, the prevalence of type 2 diabetes is increasing rapidly. Included among the therapeutic approaches to type 2 diabetes are drugs designed to increase insulin production by the pancreas, drugs to reduce glucose production by the liver, and drugs to increase the body's sensitivity to insulin, thereby improving glucose disposal by the bloodstream. Of these insulin sensitizers, Avandia and Actos represent the largest class of oral anti-diabetic agents, garnering approximately $6 billion in worldwide sales annually.

Hollis-Eden Pharmaceuticals

Hollis-Eden Pharmaceuticals, Inc. is a world leader in the development of a proprietary class of adrenal steroid hormones as novel pharmaceuticals for human health. Through its Hormonal Signaling Technology Platform, Hollis-Eden is developing a new series of small molecule compounds that are metabolites or synthetic analogs of endogenous hormones derived by the adrenal glands from the body's most abundant circulating adrenal steroid. These steroid hormones, designed to restore the biological activity of cellular signaling pathways disrupted by disease and aging, have been demonstrated in humans to possess several properties with potential therapeutic benefit -- they regulate innate and adaptive immunity, reduce nonproductive inflammation and stimulate cell proliferation. The Company's clinical drug development candidates include TRIOLEX, a next-generation compound currently in a clinical trial for the treatment of type 2 diabetes and being prepared for potential clinical trials in rheumatoid arthritis, and HE3235, a next-generation compound selected for cancer. In addition to these clinical development candidates, Hollis-Eden has an active research program that is generating additional new clinical leads that are being further evaluated in preclinical models of a number of different diseases. For more information on Hollis-Eden, visit the Company's website at www.holliseden.com.

This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, the potential and prospects of the Company's drug discovery program and its drug candidates. Any statement included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause the Company's actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in the Company's business, including, but not limited to: the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to obtain regulatory approval for TRIOLEX, HE3235 or any other investigational drug candidate; the Company's future capital needs; the Company's ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual property rights of others; 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. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.

Source: Business Wire

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