Hollis-Eden Pharmaceuticals related Press Releases

Hollis-Eden Pharmaceuticals Presents Additional Positive Findings for APOPTONETM (HE3235) in Preclinical Models of Castration-Re

Calisha Myers — Mon, 29 Sep 2008 08:54:29 -0400

Hollis-Eden Pharmaceuticals Presents Additional Positive Findings for APOPTONE^TM (HE3235) in Preclinical Models of Castration-Resistant Prostate Cancer

September 29, 2008

SAN DIEGO--(BUSINESS WIRE)--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today presented new findings that suggest APOPTONE^TM (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 13^th International Congress on Hormonal Steroids and Hormones & Cancer being held in Quebec City, Canada, September 27^th - 30^th. 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^TM (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^TM (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.

PRESS RELEASE: Hollis-Eden Pharmaceuticals Presents Positive Results with Novel Drug Candidate HE3235

Maureen Martino — Thu, 04 Oct 2007 09:57:32 -0400

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

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.

PRESS RELEASE: Hollis-Eden Pharmaceuticals Presents HE3235 Update at ASCO Breast Cancer Symposium

Maureen Martino — Fri, 07 Sep 2007 10:58:48 -0400

Hollis-Eden Pharmaceuticals Presents HE3235 Update at ASCO Breast Cancer Symposium

Preclinical Data Show Lasting Anti-Tumor Effect of Novel Drug Candidate

SAN DIEGO -- Hollis-Eden Pharmaceuticals, the leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, today reported on its progress with HE3235, its investigational oral drug candidate for the treatment of cancer. Data being presented today at The 2007 ASCO Breast Cancer Symposium, being held September 7-8 in San Francisco, California, demonstrate that HE3235, as previously reported, significantly inhibited the incidence of new tumors and stopped the growth of existing tumors in a preclinical model of breast cancer. Updated data presented at this conference indicate that existing tumors in the HE3235-treated animals from this preclinical model had still not progressed and no new tumors were reported during the five weeks of observation after dosing stopped, in contrast to the vehicle-treated animals in which tumors continued to proliferate. Additionally, the Company reported that when animals with existing tumors were dosed at one half the strength of the lowest dose previously tested, HE3235 stopped tumor progression in these animals.

The new data indicating that the anti-tumor benefit of HE3235 was sustained for five weeks after dosing stopped are striking in light of the fact that approved breast cancer treatments lose activity once treatment is discontinued. The Company plans to file an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2008 in order to initiate a planned Phase I/II clinical trial with HE3235 for the treatment of cancer.

The previously reported data being presented at the Breast Cancer Symposium are from an animal model in which rats were given the potent carcinogen N-methyl-N-nitrosourea to induce multiple breast tumors. Animals with detected tumors were randomized to receive one of two strengths of HE3235 or 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 placebo control treated animals developed one or more additional tumors, while not a single new tumor arose in the animals treated with HE3235. This preventive action of HE3235 on the occurrence of new tumors also reached statistical significance (p less than 0.01).

â€œThe effect of HE3235 to inhibit new tumor growth and stop tumor progression in this model was impressive, but what was unexpected and exciting was that the compound appeared to have a lasting effect even after dosing was stopped,â€ stated Dr. Rajkumar Lakshmanaswamy, Assistant Professor, Department of Pathology, Texas Tech University Health Sciences Center, who conducted the study and reported on the findings at the ASCO symposium.

â€œThese data hold the promise that HE3235, if successfully developed, could offer a new treatment option for women with breast cancer,â€ stated Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. â€œThe lasting anti-tumor effect of HE3235 reported in this animal model of breast cancer suggests the compound is causing tumor cells to undergo apoptosis, or die. Therefore, the compound may act through a novel mechanism of action that could make it useful in treating multiple types of cancer. Due to this potential and the previously reported activity with HE3235 in prostate cancer models, we are aggressively pursuing the mechanism of action and the activity of the drug candidate in other models of cancer. HE3235 represents yet another novel pharmaceutical drug candidate developed out of our hormone signaling technology platform and yields a program in cancer to augment our expanding drug development pipeline in metabolic disorders and diseases of inflammation, such as type 2 diabetes and rheumatoid arthritis.â€

Currently the leading approved drug treatments for prostate or breast cancer focus on blocking the effects of testosterone or estrogen and generate annual sales ranging from approximately $500 million to $2 billion.

Hollis-Eden Pharmaceuticals

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 bodyâ€™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 Companyâ€™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 Companyâ€™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 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 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.