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Hollis-Eden Pharmaceuticals, Inc. announced today that it has filed an Investigational New Drug (IND) application with the FDA to begin clinical trials with its oral drug candidate APOPTONE(TM) (HE3235) for the treatment of hormone receptor sensitive cancers
SAN DIEGO, CA, USA | February 19, 2008 | Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin clinical trials with its oral drug candidate APOPTONE(TM) (HE3235) for the treatment of hormone receptor sensitive cancers. Assuming clearance of the IND by the FDA, Hollis-Eden plans to initiate a Phase I/II dose ranging clinical trial of APOPTONE in prostate cancer patients during the second quarter of 2008. The patient population for this initial clinical trial will be considered "late stage," which is defined as patients failing at least one round of chemotherapy.
"We are excited to be filing an IND for APOPTONE for hormone sensitive cancers to enable us to initiate our clinical trial in prostate cancer," said Richard B. Hollis, Chairman and CEO of Hollis-Eden Pharmaceuticals. "This is the fourth IND we have filed in less than a year, and assuming the FDA clears our IND, we plan to begin enrolling patients for this clinical trial by the second quarter of 2008. The indications we are targeting, including type 2 diabetes, ulcerative colitis, prostate cancer, and rheumatoid arthritis, are major market opportunities for Hollis-Eden. By initiating clinical trials in these multiple indications we are leveraging our Hormonal Signaling Technology Platform with the goal of delivering novel, first-in-class pharmaceuticals. I am extremely proud of our clinical and regulatory teams as they continue to execute our corporate goals for our two leading drug candidates TRIOLEX(TM) (HE3286) and APOPTONE (HE3235), strategically positioning us to possibly deliver initial data from these clinical trials this year. Our goal is to successfully emerge from these clinical trials with breakthrough products that offer patients better, safer, and more cost effective pharmaceuticals that will greatly enhance their quality of life and position Hollis-Eden as the next emerging high growth company."
"The preclinical activity we observed with APOPTONE in androgen-independent and hormone-independent prostate cancer tumor models gives us confidence as we enter into clinical trials in prostate cancer patients," stated Dr. Dwight Stickney, Hollis-Eden's Chief Medical Officer. "These prostate cancer preclinical models are representative of later stage prostate cancer where traditional hormonal blockade therapy cease working. This initial dose ranging clinical study in prostate cancer is designed to understand the safety, pharmacokinetics, activity and maximum tolerated dose of APOPTONE in this patient population."
As Hollis-Eden has previously reported, in preclinical models of prostate and breast cancer, treatment with APOPTONE significantly inhibited the incidence, growth and progression of tumors. In studies conducted by Hollis-Eden using the LNCaP human prostate cancer cell line, treatment with APOPTONE reduced the incidence of LNCaP tumors in a dose dependent fashion and, in the high-dose group, completely prevented tumor growth, compared to 92% tumor incidence in vehicle-treated animals. In a separate model, mice with established LNCaP prostate tumors were randomized to receive treatment with either APOPTONE 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 than in animals treated with APOPTONE (p less than 0.001), with 2 out of the 9 treated animals becoming completely tumor free.
In a preclinical study of late-stage human prostate cancer conducted by Eva Corey, Ph.D., Research Associate Professor Department of Urology, University of Washington, APOPTONE significantly inhibited the rate of tumor growth. In that study, 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 APOPTONE treatment and control groups and dosed for 28 days. The results of this study showed that APOPTONE 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 APOPTONE treatment and control groups during week four (p = 0.005). Hollis-Eden considers this LuCaP 35V data to be particularly exciting because it extends the activity of APOPTONE 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.
Hollis-Eden believes the mechanism of APOPTONE in inhibiting prostate tumor growth in these preclinical studies appears to be due to the tumor cells undergoing programmed cell death, or apoptosis. Analysis of gene expression from tumors in the preclinical studies indicate APOPTONE appears to act as an apoptotic agent, down regulating genes that protect tumor cells from apoptosis such as Bcl-2 while increasing the expression of pro-apoptotic genes such as caspases. Preclinical findings also show that APOPTONE may increase the susceptibility of tumor cells to chemotherapeutic agents by down-regulating the gene for the multi-drug resistant protein MDR2, originally known as the Breast Cancer Resistance Protein (BCRP).
In the United States alone approximately 234,000 patients are diagnosed annually with prostate cancer and approximately 30,000 men die from the disease each year. 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.
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 clinical trials for the treatment of type 2 diabetes, ulcerative colitis 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.
SOURCE: Hollis-Eden Pharmaceuticals, Inc.
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