HEPH Hollis-Eden Pharmaceuticals (MM)

Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today presented new findings that suggest APOPTONE� (HE3235) is inhibiting in preclinical models of castration-resistant prostate cancer, the ability of tumors to synthesize the hormones necessary for their survival, as well as significantly down regulating the androgen receptor. Recent reports from the scientific literature indicate that androgen receptor signaling is active in all stages of prostate cancer, including late stage castration-resistant prostate cancer, and that castration-resistant prostate cancer may be driven by the intratumoral production of androgens. The Company�s new findings were reported this week at the 13th International Congress on Hormonal Steroids and Hormones & Cancer being held in Quebec City, Canada, September 27th � 30th. Dr. Richard Trauger, Director of Infectious Disease and Cancer at Hollis-Eden Pharmaceuticals, presented the data, from work performed by Dr. Eva Corey, Research Associate Professor, Department of Urology, at the University of Washington. Preclinical Data Presented Using the castration-resistant LuCaP 35V xenograft model (human prostate tumors implanted in immunodeficient mice), Dr. Trauger reported that APOPTONE treatment significantly reduced tumor volume (p < 0.05), and delayed tumor-doubling time relative to that in vehicle-treated animals. An analysis of tumor samples from these mice also demonstrated that APOPTONE lowered levels of androgen receptor protein and significantly reduced gene expression relative to the vehicle controls (p < 0.05). In addition, tumors in mice treated with APOPTONE had reduced levels of testosterone and dihydrotestosterone (DHT) relative to the vehicle-treated animals, suggesting that APOPTONE suppressed hormone synthesis directly within the tumors. These preclinical results demonstrate that APOPTONE significantly inhibits tumor growth in this model of castration-resistant prostate cancer, apparently by suppressing critical hormones and receptors necessary for tumor cell survival. Data were also presented from a separate model of prostate mediated bone disease, where C4-2B castration-resistant tumor cells were implanted directly into the tibia of castrated SCID mice. APOPTONE treatment significantly lowered the tumor bearing tibia weight and reduced PSA levels relative to the vehicle-treated animals (p < 0.05). �We are excited to be collaborating with Hollis-Eden to test in a Phase I/II clinical trial whether APOPTONE treatment can help patients in the later stages of prostate cancer where there are very few treatment options,� stated Bruce Montgomery, M.D., Associate Professor, Division of Oncology, University of Washington. �APOPTONE appears in preclinical studies to suppress the androgen receptor while also inhibiting the ability of castration-resistant tumor cells to synthesize their own androgens. The potential that APOPTONE acts to cut off the tumors� fuel supply and cause programmed cell death is completely different from the effect of classical hormonal blockade therapy.� Ongoing Phase I/II Clinical Trial The Phase I/II clinical trial, now currently enrolling patients, is a dose escalation trial currently scheduled to evaluate up to four different dosing groups to determine the maximum tolerated dose. Primary objectives of the study are to determine the safety, tolerance, pharmacokinetics and potential activity of the compound over 28 day dosing cycles in up to 44 patients with advanced prostate cancer who have failed hormone therapy and at least one round of taxane-based chemotherapy. Potential activity of the compound will be measured by standard prostate-specific antigen (PSA) tests and effect on well-established markers of progression-free survival (PFS) such as CT scan, MRI and circulating tumor cells. If any signs of activity are observed in a particular dosing regimen the Company plans to expand the number of patients in order to confirm the findings and initiate a Phase II clinical study at the safest and most effective dose or dosing regimens. �Hormone sensitive cancers, such as prostate and breast cancer, are among the most commonly diagnosed cancers in men and women, respectively,� stated Richard Hollis, Chairman and CEO, Hollis-Eden Pharmaceuticals. �Our expertise in steroid chemistry and our experience in working with steroid hormone chemical structures for over a decade have allowed us to synthesize and screen hundreds of chemical structures for activity in hormone sensitive cancers. APOPTONE represents years of work to identify an active steroidal chemical structure that to date has performed remarkably well in preclinical models of both prostate and breast cancer. Data presented today by Dr. Trauger in prostate cancer are especially encouraging as we bring APOPTONE into human clinical trials. The fact that APOPTONE has inhibited the growth of human tumors in animal models of prostate cancer, and now has been shown in an animal model to apparently suppress hormone synthesis directly within the tumor, should bode well for potential human translation in our current trial in prostate cancer patients.� �Over the last several weeks,� added Hollis, �our scientists have presented data at the International Autoimmune Conference in Porto, Portugal, at the World Congress on Insulin Resistance in Los Angeles, California, and today at the International Congress on Hormonal Steroids & Hormones and Cancer meeting in Quebec City, Canada. Presenting our data at scientific conferences around the world allows us the opportunity to establish our data with luminaries and thought leaders in various fields of medicine as well as to provide updated information about our development programs to investors. We will continue to have our scientists present our scientific findings at conferences to build the validation for our science and will submit those findings for future publication in scientific journals, which typically lag the actual issuance of data by several months or longer. We remain focused on generating data from our currently enrolling clinical trials in prostate cancer, type-2 diabetes, ulcerative colitis and rheumatoid arthritis and expect that positive data from these trials would be our value drivers in the near-term.� Prostate Cancer Market Approximately 234,000 patients are diagnosed with prostate cancer each year in the United States. The pharmaceutical market for treating prostate cancer is approximately $7 billion per 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 $1.8 billion. With approximately 30,000 men in the United States dying from prostate cancer each year, there remains a tremendous unmet medical need where novel treatments are needed. About 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� (HE3286), a next-generation compound currently in clinical trials for the treatment of type 2 diabetes and ulcerative colitis and being prepared for clinical trials in rheumatoid arthritis, and APOPTONE� (HE3235), a next-generation compound selected for clinical development 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 and the benefits to be derived therefrom including the potential advantages of APOPTONE compared to other treatment approaches, how APOPTONE is believed to work and its potential for use in the treatment of prostate cancer or other cancers. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. 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 risks and uncertainties inherent in clinical trials, and drug development and commercialization, including the uncertainty of whether results in preclinical and clinical testing of APOPTONE to date will be predictive of results in later stages of development; 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 obtain and protect its intellectual property rights and to not infringe the intellectual property rights of others; the development of competitive products by other companies, the market potential for prostate cancer and the other markets the Company is targeting, and the Company�s ability to compete; 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. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement. 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. None of the Company's drug candidates has been approved for sale, significant additional animal and human testing is required in order to seek marketing approval for any of its drug candidates, and the Company cannot assure you that marketing approval can be obtained for any of its drug candidates or that, even if such marketing approval were received, such drug candidates would ultimately achieve commercial success. Furthermore, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of the Company's preclinical and clinical data, so its views remain subject to change.