Healthcare Industry News:  Immunopharmacology 

Biopharmaceuticals Regenerative Medicine Oncology

 News Release - October 2, 2006

Hollis-Eden Pharmaceuticals Provides Update on Bone Marrow Regeneration Program and Chemotherapy Indication

SAN DIEGO--(HSMN NewsFeed)--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH ) announced today an update on its progress in developing novel small molecule compounds with cellular and tissue regenerative properties that could play a beneficial therapeutic role in radiation- and chemotherapy-induced bone marrow suppression. As reported at the 35th Annual Scientific Meeting of the International Society for Experimental Hematology ("ISEH") held September 27-30, 2006, in Minneapolis, Minnesota, and in the November 2006 issue of International Immunopharmacology (available at www.elsevier.com), Hollis-Eden is advancing development of first- and second-generation compounds that demonstrate the ability to maintain bone marrow function and stimulate multilineage hematopoiesis after radiation- or chemotherapy-induced toxicity.

As reported, preclinical findings with the Company's lead compound for Acute Radiation Syndrome (ARS), NEUMUNE(TM) (HE2100), demonstrate that the compound reduced duration of severe neutropenia, thrombocytopenia and anemia in rhesus monkeys exposed to 4.0 Gy of total body irradiation. Repopulation of neutrophils, platelets and red blood cells at about day 15 following irradiation demonstrated an accelerated recovery of the bone marrow that occurs by stimulation of hematopoietic stem or progenitor cells. Such an effect on early-stage bone marrow cells has been shown with NEUMUNE in preclinical studies conducted by Dr. Gerard Wagemaker, a leading radiobiologist at Erasmus University in The Netherlands. In those studies, Dr. Wagemaker demonstrated that NEUMUNE enhanced cellular recovery in the blood and bone marrow of monkeys exposed to 6.0 Gy of radiation, with a median 40-fold increase in CD34+ hematopoietic stem and progenitor cells when compared to the placebo control. Additional studies conducted by Hollis-Eden with NEUMUNE demonstrated that the compound stimulated multilineage hematopoiesis in unirradiated humans and improved survival in lethally irradiated monkeys. These results support a potential role for NEUMUNE and related molecular entities in regenerative medicine.

Based on the regenerative properties of NEUMUNE, Hollis-Eden is now pursuing a program to develop a therapy that will reduce the cumulative damaging effects of chemotherapy by sustaining and restoring bone marrow function throughout multiple courses of chemotherapy. As highlighted in the presentation at the ISEH meeting, Hollis-Eden is investigating HE3210, a second-generation compound with pharmaceutical properties tailored for chemotherapy recovery. HE3210 has been studied in various bone marrow insult models, demonstrating stimulation of hematopoiesis in both radiation- and chemotherapy-induced bone marrow injury in monkeys, as well as in healthy monkeys. Hollis-Eden also is profiling other second-generation compounds designed to be orally bioavailable. Further studies are planned with HE3210 and other second-generation compounds with the objective of identifying a chemotherapy protection candidate for clinical development.

While the evolution of chemotherapy over the past decades resulted in broadly available therapy for cancer patients, it has become apparent that to achieve the optimal effect of chemotherapy, it is necessary to deliver multiple cycles in close succession. The cumulative damage of chemotherapy on the bone marrow, however, often limits the optimal delivery of chemotherapy, resulting in reduced dose levels or increased time intervals between each cycle of chemotherapy. Clinical studies have shown a direct dose-response and schedule relationship to improved outcomes, such as survival, in cancer chemotherapy. Even minor dose reductions or schedule delays can result in significantly reduced cure rates in chemo-sensitive tumors.

Oncologists currently treat chemotherapy-induced bone marrow damage with growth factors and transfusions to restore blood elements, the production of which is decreased by bone marrow damage. An ideal hematopoietic compound would be capable of restoring the bone marrow and sustaining robust production of essential blood elements throughout all courses of therapy, thereby allowing for optimal dosing and scheduling of chemotherapy treatment.

"Our development efforts in myelosuppression continue to demonstrate that our class of hormonal signaling molecules provide multi-lineage hematopoietic effects which we believe result from their apparent ability to regenerate bone marrow progenitor and stem cells," said Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. "These properties suggest a potential regenerative role for our Hormonal Signaling Technology Platform in a variety of indications where tissue is damaged and function is compromised. Among these is chemotherapy-induced bone marrow suppression, where our goal is to develop a drug candidate that limits the cumulative toxicities associated with chemotherapy, thereby enabling optimal treatment regimens and enhancing cancer patient outcomes."

"In support of our efforts," added James M. Frincke, Ph.D., Chief Scientific Officer of Hollis-Eden, "we are expanding our collaborations in other areas of regenerative medicine with Dr. Wagemaker and other thought leaders. These collaborations will further define the mechanism of action of our compounds and their role in signaling stem and progenitor cell fate decisions to restore other damaged or aged tissues in addition to bone marrow."

About Hollis-Eden

Hollis-Eden Pharmaceuticals, Inc. is developing a proprietary new class of small molecule compounds that are metabolites or synthetic analogs of adrenal steroid hormones. These compounds, 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 lead product candidate, NEUMUNE(TM) (HE2100), is entering late-stage development for the treatment of Acute Radiation Syndrome (ARS), a life-threatening condition resulting from exposure to high levels of radiation following a nuclear or radiological incident, and is being explored for use in combating healthcare-associated infections. Hollis-Eden also is profiling optimized second-generation compounds for potential clinical development in a broad spectrum of therapeutic categories including hematology, metabolic disorders, autoimmune disorders, pulmonary diseases, oncology and infectious 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 NEUMUNE under the U.S. Food and Drug Administration Animal Efficacy Rule, even if shown to be effective in preclinical studies; the ability to receive any stockpiling orders for NEUMUNE from the U.S. federal, state and foreign governments or agencies, even if approved by regulatory authorities; 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

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