Hollis-Eden Pharmaceuticals Presents Additional Data Demonstrating Activity of Apoptone in Inducing Cancer Cell DeathSAN DIEGO--(BUSINESS WIRE)--Feb. 5, 2008 - Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH), the world leader in the development of a new class of small molecule compounds based on endogenous adrenal steroid hormones, today announced that it is presenting preclinical data at the 19th International Congress on Anti-Cancer Agents, being held February 5-8 in Paris, France, further demonstrating that the Company's lead cancer compound, Apoptone(TM) (HE3235), directly induces apoptosis, or cell death, in tumor cells. Hollis-Eden intends to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) this month to initiate a Phase I/II clinical trial in late-stage prostate cancer patients.
In an oral presentation, Dr. Richard Trauger, Director of Cancer and Infectious Disease at Hollis-Eden, presented data showing that APOPTONE induces apoptosis by concomitantly increasing the expression of pro-apoptotic genes such as caspases, that can cause tumor cells to die, and reducing the expression of anti-apoptotic genes such as BCL2, that prevent tumor cell death. Data also are being presented showing that APOPTONE may increase the susceptibility of tumor cells to chemotherapeutic agents by down-regulating ABCG2, the gene for the multi-drug resistant protein MDR2, also known as the Breast Cancer Resistance Protein (BCRP). These new findings further validate the activity of APOPTONE as a cytotoxic agent for tumor cells and suggest that APOPTONE's mechanism of action appears to be the induction of genes associated with cell death pathways in tumor cells, as opposed to traditional hormone therapies directed at simply interrupting either the synthesis or the signaling of the tumor cell through the androgen or estrogen receptor.
"APOPTONE represents a potentially exciting, novel hormone-based cytotoxic treatment for prostate cancer patients as well as other hormone sensitive cancers, such as breast cancer," said radiation oncologist Dr. Dwight Stickney, Hollis-Eden's Chief Medical Officer. "Our positive preclinical results in prostate and breast cancer models, combined with extensive gene array analysis, suggest APOPTONE could enhance the effectiveness of chemotherapy or potentially provide benefit in later stage prostate cancer patients where traditional treatments have failed. With approximately 30,000 men in the United States dying from prostate cancer each year, this is still a tremendous unmet medical need where novel treatments are desperately needed."
These gene array data were presented along with previously reported preclinical findings with APOPTONE in LNCaP and LuCaP 35V tumor models as well as a MNU carcinogen-induced breast cancer preclinical model which showed that treatment with APOPTONE significantly inhibited the incidence, growth and progression of tumors.
"It is rewarding to be able to showcase our preclinical work with APOPTONE at this important international cancer meeting," stated Richard B. Hollis, Chairman and CEO, Hollis-Eden Pharmaceuticals. "The gene array data being presented today by Dr. Trauger continue to reveal why we are demonstrating such robust anti-tumor effect with APOPTONE treatment in preclinical models of prostate and breast cancer. Yielding such an exciting drug candidate out of our core technology platform validates our investment in this area and positions our company to create significant value. Our initial Phase I/II clinical trial, assuming clearance of our IND by the FDA, will be conducted in late stage prostate cancer patients where we can assess the safety of a range of dosing regimens and potentially demonstrate early activity of APOPTONE. Our cancer programs are now rapidly catching up to our clinical programs with TRIOLEX in metabolic disorders and diseases of inflammation. Advancing clinical trials into multiple indications such as type 2 diabetes, rheumatoid arthritis and now hormone sensitive cancers demonstrates that our Hormonal Signaling Technology Platform is yielding drug candidates that are novel, first-in-class, and potentially breakthrough pharmaceuticals. Our commitment to our vision and our core technology platform for the past decade is now delivering potential drug candidates that may offer new hope for patients while creating a new, emerging high-growth biopharmaceutical company."
Hollis-Eden Pharmaceuticals, Inc.
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(TM) (HE3286), a next-generation compound currently in a clinical trial for the treatment of type 2 diabetes and being prepared for clinical trials in rheumatoid arthritis, and APOPTONE(TM) (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 (HE3286), APOPTONE (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.
Hollis-Eden Pharmaceuticals, Inc.
Scott Rieger, Director, Corporate Communications
Posted: February 2008