Hollis-Eden Pharmaceuticals Inc. Up on Cancer Study Data

SAN DIEGO--(BUSINESS WIRE)--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH), the leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, today reported on its progress with HE3235, its investigational oral drug candidate for the treatment of cancer. Data being presented today at The 2007 ASCO Breast Cancer Symposium, being held September 7-8 in San Francisco, California, demonstrate that HE3235, as previously reported, significantly inhibited the incidence of new tumors and stopped the growth of existing tumors in a preclinical model of breast cancer. Updated data presented at this conference indicate that existing tumors in the HE3235-treated animals from this preclinical model had still not progressed and no new tumors were reported during the five weeks of observation after dosing stopped, in contrast to the vehicle-treated animals in which tumors continued to proliferate. Additionally, the Company reported that when animals with existing tumors were dosed at one half the strength of the lowest dose previously tested, HE3235 stopped tumor progression in these animals.

The new data indicating that the anti-tumor benefit of HE3235 was sustained for five weeks after dosing stopped are striking in light of the fact that approved breast cancer treatments lose activity once treatment is discontinued. The Company plans to file an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2008 in order to initiate a planned Phase I/II clinical trial with HE3235 for the treatment of cancer.

The previously reported data being presented at the Breast Cancer Symposium are from an animal model in which rats were given the potent carcinogen N-methyl-N-nitrosourea to induce multiple breast tumors. Animals with detected tumors were randomized to receive one of two strengths of HE3235 or assigned to a placebo control group. Treatment with HE3235 resulted in a reduced tumor burden for existing tumors that were present before treatment commenced compared to placebo-treated animals (p less than 0.001). In addition, after the treatment period began, all placebo control treated animals developed one or more additional tumors, while not a single new tumor arose in the animals treated with HE3235. This preventive action of HE3235 on the occurrence of new tumors also reached statistical significance (p less than 0.01).

“The effect of HE3235 to inhibit new tumor growth and stop tumor progression in this model was impressive, but what was unexpected and exciting was that the compound appeared to have a lasting effect even after dosing was stopped,” stated Dr. Rajkumar Lakshmanaswamy, Assistant Professor, Department of Pathology, Texas Tech University Health Sciences Center, who conducted the study and reported on the findings at the ASCO symposium.

“These data hold the promise that HE3235, if successfully developed, could offer a new treatment option for women with breast cancer,” stated Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. “The lasting anti-tumor effect of HE3235 reported in this animal model of breast cancer suggests the compound is causing tumor cells to undergo apoptosis, or die. Therefore, the compound may act through a novel mechanism of action that could make it useful in treating multiple types of cancer. Due to this potential and the previously reported activity with HE3235 in prostate cancer models, we are aggressively pursuing the mechanism of action and the activity of the drug candidate in other models of cancer. HE3235 represents yet another novel pharmaceutical drug candidate developed out of our hormone signaling technology platform and yields a program in cancer to augment our expanding drug development pipeline in metabolic disorders and diseases of inflammation, such as type 2 diabetes and rheumatoid arthritis.”

Currently the leading approved drug treatments for prostate or breast cancer focus on blocking the effects of testosterone or estrogen and generate annual sales ranging from approximately $500 million to $2 billion.

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 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 HE3286, 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 statements 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 HE3286, 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.

Contacts Hollis-Eden Pharmaceuticals, Inc. Scott Rieger, Director, Corporate Communications (858) 587-9333