Hollis-Eden Pharmaceuticals Presents Positive Results with Novel Drug Candidate HE3235 in Model of Hormone Independent Prostate Cancer
SAN DIEGO -- Oct 4, 2007 - Hollis-Eden Pharmaceuticals the world leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, today announced new preclinical data with its drug candidate HE3235 for the treatment of cancer.
Data reported this week in an oral presentation at the 4th International Conference on Tumor Progression & Therapeutic Resistance, held October 4-5, 2007 in Philadelphia, Pennsylvania, demonstrated that HE3235 significantly inhibited tumor growth in a preclinical model of hormone-independent prostate cancer utilizing human tumor cells. Hormone independent tumors are associated with late-stage prostate cancer, a condition for which there currently is no effective treatment. Additionally, mechanism of action data were presented showing that HE3235 lowers the expression of the anti-apoptotic gene BCL2 and induces apoptosis (cell death) in LNCaP cells. Furthermore, the induction of apoptosis appears to be independent of endogenous hormones that may induce tumor cell proliferation. These data suggest that the activity of HE3235 is due, at least in part, to its ability to kill tumor cells. The findings reported this week suggest that if successfully developed, HE3235 may offer benefit in late-stage prostate cancer, the second leading cause of death in men in the United States today.Â
Pharmacokinetic data were also presented demonstrating that HE3235 is orally bio-available in rodents and non-human primates. These findings, along with the previously described activity of HE3235 in a model of LNCaP androgen-independent prostate cancer and in a MNU carcinogen-induced model of breast cancer, will serve as the basis for the Company's submission of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for the treatment of cancer in the first quarter of 2008.
The study reported this week was performed by Eva Corey, Ph.D., Research Associate Professor Department of Urology, University of Washington. In this model of late-stage human disease developed by Dr. Corey, animals were injected with the human prostate cancer cell xenograft LuCaP 35V, a tumor cell type that is known to grow independently of any hormone stimulation. Once tumors reached 100 cubic millimeters, animals were separated into HE3235 treatment and control groups (n=12 per group) and dosed for 28 days. The results of this study showed that HE3235 significantly inhibited the rate of tumor growth in comparison to untreated tumors by the third week of the study (p=0.038), with a greater difference in the rate of growth achieved between the HE3235 treatment and control groups during week four (p=0.005). The Company considers this LuCaP 35V data to be particularly exciting because it extends the activity of HE3235 beyond the previously described activity in models of hormone sensitive tumors to a model of hormone-independent tumors, which are associated with late-stage prostate cancer disease.
"To date, we are impressed with the activity of HE3235 in models of advanced prostate cancer," said Dr. Corey. "The LuCaP 35V xenograft is one of our tumor models that simulates late-stage disease in patients. Our next step is to investigate the mechanism of action of HE3235 by gene array analysis. In addition, based on the activity of HE3235 against LuCaP 35V and LNCaP, we are planning to test HE3235 efficacy to inhibit growth of prostate cancer xenografts in the bone environment."
"We still see approximately 30,000 patients dying each year of prostate cancer, the vast majority (85%+) having bone metastases," said Robert Vessella, Ph.D., Professor and Director, Genitourinary Cancer Research Laboratory, Department of Urology, University of Washington. "The fact that HE3235 was active in both LNCaP and LuCaP 35V models suggests that the compound might be effective in treating advanced prostate cancer. We are excited to continue our collaboration with Hollis-Eden to test HE3235 in our models of bone metastases." Dr. Vessella will be presenting the results with HE3235 in models of advanced prostate cancer at the Prostate Cancer Foundation Annual Meeting being held October 11-13, 2007 in Lake Tahoe, California.
"With these exciting data and our IND filing planned for the first quarter of 2008, we are rapidly advancing our cancer program and driving our product pipeline into the clinic along with our other opportunities in metabolic disorders and diseases of inflammation," added Richard B. Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals.
Approximately 234,000 patients are diagnosed each year with prostate cancer. The pharmaceutical market for treating prostate cancer is approximately $7 billion annually. Current treatments for prostate cancer focus on blocking testosterone and other hormones associated with disease progression and range in annual sales from $500 million to $1 billion.
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 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 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.