Hollis-Eden Pharmaceuticals Presents Additional Positive Data with Novel Steroid Hormone in Models of Prostate and Breast Cancer
SAN DIEGO--(BUSINESS WIRE)--Feb 22, 2007 - Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) announced today the presentation of additional positive data with the Company's novel steroid compound HE3235 in preclinical models of hormone refractory prostate cancer (HRPC) and breast cancer. New data presented indicated HE3235 arrested the growth of established prostate tumors whereas placebo-treated animals continued to experience rapid tumor growth. In addition, data were presented indicating HE3235 reduced the tumor incidence and the tumor burden in a carcinogen induced breast cancer model. The results are being presented this week by Dr. Richard Trauger, Hollis-Eden's Director of Infectious Diseases and Cancer, at the American Society for Clinical Oncology's Prostate Cancer Symposium in Orlando Florida.The data presented this week extend preclinical findings the Company presented at an earlier meeting indicating HE3235 reduced prostate tumor incidence in a dose dependent fashion. In this latest prostate model, mice with rapidly growing prostate tumors were randomized to receive treatment with either HE3235 or placebo, and tumors were then tracked for three weeks. At the end of the study, tumor volume in the animals receiving placebo was on average over 7 times larger (370 cubic millimeters) than their initial size. In contrast, tumor growth in the HE3235 group was arrested at approximately 57 cubic millimeters (p less than 0.001), with 2 out of the 9 treated animals becoming completely tumor free. The Company believes HE3235 can inhibit hormone refractory prostate cancer by blocking adrenal hormone growth factors.
Other data also support the concept that HE3235 can block these adrenal hormone growth factors. Preliminary results from the first in a series of breast cancer studies were also reported at this meeting. Rats were given the potent carcinogen N-methyl-N-nitrosourea to induce multiple breast tumors. Later in the experiment, animals with detected tumors were randomized to receive one of two strengths of HE3235 or to be 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 6 placebo controls developed one or more additional tumors, while not a single new tumor arose in the 10 animals treated with HE3235. This preventive action of HE3235 on the occurrence of new tumors also reached statistical significance (p less than 0.01).
"We are very encouraged by our initial positive results with HE3235 in this animal model used to induce breast cancer," stated Dr. Rajkumar Lakshmanaswamy, Assistant Professor, Department of Pathology, Texas Tech University Health Sciences Center. "We have used this model system to screen new and existing drug candidates for their potential activity in breast cancer for over 15 years. HE3235 appears to be as effective as anything we have tested in this model system."
The current pharmacologic standard of care in breast cancer treatment is a class of drugs known as aromatase inhibitors. In 2006 aromatase inhibitors recorded sales in excess of $2.4 billion and are projected to grow to $3.7 billion by 2009. According to the National Cancer Society, in 2006 prostate and breast cancers accounted for 33% and 31% of new cancers in men and women respectively. Standard hormone therapy that blocks the production of androgens and estrogens can effectively control these hormonally regulated cancers for a period of time. However, hormone therapy can eventually fail and both prostate and breast cancer continue to grow and spread, possibly through the use of endogenously produced adrenal hormones as tumor growth factors. HE3235 is being developed as a therapy to block the ability of these tumors to use estrogen and other adrenal hormones to grow.
"Given our scientific knowledge and expertise developed in steroid hormone research over the past decade, Hollis-Eden Pharmaceuticals is uniquely positioned to develop new hormone-based drug candidates as first-in-class medicines to treat hormone sensitive cancers," said Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. "The data presented at this scientific conference now indicate that HE3235 has robust activity in well accepted preclinical models of prostate and breast cancer. Since cancer patients often become refractory to treatment with currently approved therapies, new treatment options with fewer side effects are desperately needed.
"To date," added Hollis, "HE3235 has shown good oral bioavailability in primates and an attractive safety profile. Based on these results we have selected HE3235 for clinical development and are aggressively moving the compound forward towards IND filing, subject to successful manufacturing scale-up and non-clinical toxicology studies. We are now strategically poised to have a drug candidate in clinical development for cancer to augment our other programs in radiation protection, metabolism, autoimmunity/inflammation, and infectious diseases. By the first half of 2008, we have the potential to have drug candidates in five or more clinical indications. Clearly the broad opportunities for our novel hormonal signaling technology platform are beginning to be realized as we continue to advance new drug candidates into important clinical applications where there are unmet medical needs."
About Hollis-Eden
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 are 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 lead product candidate, NEUMUNE(R) (HE2100), is entering late-stage development for the treatment of Acute Radiation Syndrome (ARS), a life-threatening condition resulting from exposure to high levels of radiation following a nuclear or radiological incident, and is being explored for use in combating healthcare-associated infections. Hollis-Eden also is profiling optimized second-generation compounds for potential clinical development in a broad spectrum of therapeutic categories including hematology, metabolic disorders, autoimmune disorders, pulmonary diseases, oncology and infectious 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 NEUMUNE under the U.S. Food and Drug Administration Animal Efficacy Rule, even if shown to be effective in preclinical studies; the ability to receive any stockpiling orders for NEUMUNE from the U.S. federal, state and foreign governments or agencies, even if approved by regulatory authorities; 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.
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