Hollis-Eden Pharmaceuticals Presents Data on Apoptone and Potential Role of Adrenal Steroid Hormones for the Treatment of Cancer
In an oral presentation, Dr. Christopher L. Reading, Executive Vice President of Scientific Development at Hollis-Eden, presented previously reported data covering the activity of APOPTONE in preclinical models of prostate and breast cancer. Data presented illustrated the activity of APOPTONE in preclinical models of prostate cancer LNCaP and LuCaP 35V human cell lines as well as a MNU carcinogen-induced breast cancer preclinical model. In those experiments, treatment with APOPTONE significantly inhibited the incidence, growth and progression of tumors in those animal models. The Company believes the mechanism of APOPTONE in the inhibition of prostate cancer growth reported from its preclinical study in LNCaP tumor cells appears to be due to the tumor cells undergoing programmed cell death, or apoptosis. Initial analysis of gene expression from tumors in the LNCaP preclinical experiment indicated APOPTONE appears to be down regulating genes that protect tumor cells from apoptosis such as Bcl-2.
These data have now been repeated and are being supported by additional analysis of other genes associated with the apoptosis pathway. New data presented at the conference suggest that APOPTONE may also be inhibiting the AKT signaling pathway that is known to stimulate the growth of prostate cancer cells and block normal regulation of the cell cycle as well as prevent the induction of apoptosis. Additional analysis is ongoing to study the gene expression from the APOPTONE preclinical studies in LuCaP 35V prostate tumor cells as well as tumors from breast cancer preclinical models.
Dr. Reading also presented data reported from the scientific literature that links chronic inflammation to the incidence and progression of cancer, citing the potential correlation between levels of interleukin-6, or IL-6, as well as NF-kappaB activation and tumor cell proliferation. Antibodies to IL-6 are currently in clinical trials for cancer, as this new approach to treating cancer is starting to be better understood and tested. Dr. Reading presented data on the relationship between the loss of adrenal hormones as part of the aging process and rise in chronic inflammation, which is believed to contribute to the incidence and proliferation of cancer cells. To date, Hollis-Eden compounds have demonstrated in preclinical models the ability to inhibit the activation of the NF-kappaB pathway and to decrease IL-6 in vivo and in vitro in human cell lines.
As an example, chronic inflammation is known to be involved in the pathogenesis of ulcerative colitis (UC), and to contribute to the progression of colorectal carcinoma in UC patients. The Company is currently considering the use of its novel adrenal steroid hormones in the treatment of UC. The Company believes, if this new class of adrenal steroid hormones can prove to be as effective as corticosteroids and safe enough to be used longer to regulate chronic inflammation, these data presented at the conference suggest the Company's compounds may have an added benefit in the prevention of colorectal cancer, which is associated with chronic inflammation.
"We continue to make good progress understanding the role of our hormonal signaling technology platform may play in regards to preventing or treating cancer and other diseases associated with aging," stated Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. "It is gratifying for our scientists to have the opportunity to showcase our data in an oral presentation at this important international meeting for geriatric oncology. The link between the loss of adrenal hormones as we age and chronic inflammation, which may contribute to the development of cancer in the elderly, is becoming widely understood. It is important for us to continue to educate the scientific and medical community about the potential role our hormonal signaling technology platform may play in cancer and other diseases associated with aging. This is why, in addition to developing APOPTONE for cancer, we are currently in a Phase I/II clinical trial with another adrenal steroid hormone drug candidate TRIOLEX(TM) for the treatment of metabolic disorders and have been cleared by the FDA to initiate a Phase I/II clinical trial with TRIOLEX in rheumatoid arthritis, both diseases associated with aging. We are still on track to be filing our IND for APOPTONE for the treatment of cancer in the first quarter of 2008. Establishing activity in clinical trials with either APOPTONE or TRIOLEX will go a long way to validate our approach that our new class of adrenal steroid hormones may play a fundamental role in preventing or treating diseases associated with aging."
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 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, 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 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.
Contact
Hollis-Eden Pharmaceuticals, Inc.
Scott Rieger, Director, Corporate Communications
858-587-9333
Posted: November 2007
