For Immediate Release
Hollis-Eden Pharmaceuticals Announces Cystic Fibrosis Foundation Therapeutics Selects Triolex™ (He3286) as a Next-Generation Oral Anti-Inflammatory Drug Candidate
Hollis-Eden to Receive $645,000 in Milestone Payments Under Collaboration Agreement
December 20, 2007
Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH), the leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, today announced that Cystic Fibrosis Foundation Therapeutics, Inc, (CFFT), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation, has selected Hollis-Eden’s TRIOLEX™ (HE3286) as a drug candidate for lung inflammation associated with cystic fibrosis (CF) under their existing collaboration agreement. Hollis-Eden also announced that it expects to receive milestone payments totaling $645,000 from CFFT as a result of the achievement by the Company of certain development milestones under the collaboration agreement.
“We are encouraged by the completion of these early milestones by Hollis-Eden,” said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. “We look forward to continuing successes in our collaboration to bring novel anti-inflammatory therapies to CF patients.”
“We are pleased that the Cystic Fibrosis Foundation has selected TRIOLEX based on the criteria set forth in our collaboration agreement for developing a novel oral anti-inflammatory drug candidate,” said Richard B. Hollis, Chairman and CEO, Hollis-Eden Pharmaceuticals, Inc. “Cystic Fibrosis is a form of chronic obstructive pulmonary disease that causes pulmonary inflammation, and we are extremely excited about the potential of TRIOLEX to provide multifaceted benefits to these patients. We look forward to working with CFFT in the future to explore potential strategies and the economics involved in the clinical development path for TRIOLEX in cystic fibrosis. If we agree on the economics, clinical plan and an initial protocol, we will submit a separate IND for TRIOLEX with the FDA to gain clearance to initiate a clinical trial in cystic fibrosis. We believe our drug development program in diseases of inflammation has the potential to offer a major breakthrough therapy for patients suffering from multiple diseases of inflammation and autoimmunity, and now diseases of chronic obstructive pulmonary disorders (COPD).”
TRIOLEX is a novel orally bio-available adrenal steroid hormone analogue with anti-inflammatory and insulin sensitizing properties currently in clinical trials under an open Investigational New Drug application (IND) for the treatment of metabolic disorders. The Company has been cleared under a second IND with the U.S. Food and Drug Administration (FDA) to begin clinical trials with TRIOLEX for the treatment of rheumatoid arthritis.
CFFT selected TRIOLEX as a drug candidate for lung inflammation associated with CF based upon the potent anti-inflammatory activity and attractive safety profile of the compound in preclinical studies to date. In a series of preclinical studies conducted by Drs. Douglas Conrad and Angela Wang at the University of California, San Diego, inflammation was induced in the lungs of mice using an LPS (bacterial products) challenge. Groups of LPS-challenged animals were treated with either TRIOLEX or with placebo, and 48 hours later, lung tissue was collected. Compared to the placebo-treated mice, animals treated with TRIOLEX, at doses as low as 4 mg/kg, had reduced levels of myeloperoxidase, an enzyme produced by neutrophils and commonly used as a surrogate marker for acute lung inflammation, as well as reduced levels of TNF alpha and interleukin-6 (IL-6). TNF-alpha and IL-6 are cytokines thought to be key inflammatory mediators that play important underlying roles in CF and other COPDs, including asthma, chronic bronchitis and emphysema.
The anti-inflammatory activity of TRIOLEX has also been confirmed in animal models of rheumatoid arthritis, multiple sclerosis, lupus, and ulcerative colitis. The Company believes the broad-based anti-inflammatory activity of TRIOLEX may be due to the partial inhibition of the NF-kappaB pathway. NF-kappaB is a transcription factor that controls genes whose products are involved in the inflammatory signaling pathway, including TNF-alpha and IL-6. These cytokines are also implicated in the pathogenesis of autoimmune and metabolic diseases, cardiovascular disorders, cancer and in general, diseases associated with aging. Unlike currently prescribed corticosteroids that act through the glucocorticoid receptor to completely block NF-kappaB activation and can cause immune suppression and bone loss, animal studies to date show that TRIOLEX does not interact with the glucocorticoid receptor and only partially inhibits the NF-kappaB pathway without immune suppression or bone loss. In addition to its anti-inflammatory properties, TRIOLEX has also demonstrated in preclinical models glucose lowering and bone sparing activities that could provide added benefit to patients with CF.
About Cystic Fibrosis
Cystic fibrosis is a life-threatening genetic disease that affects approximately 30,000 children and adults in the United States and 70,000 people worldwide. A defective gene and its protein product cause the body to produce unusually thick, sticky mucus that clogs the lungs and leads to serious lung infections and obstructs the pancreas, causing difficulty in absorbing food. In the 1950s, few children with cystic fibrosis lived to attend elementary school. Today, due to advances in treatment and care, the predicted median age of survival is 37.
About the Cystic Fibrosis Foundation
The Cystic Fibrosis Foundation is the leading organization devoted to curing and controlling cystic fibrosis. Headquartered in Bethesda, Md., the Foundation funds CF research, has 80 chapter and branch offices in the United States, and supports and accredits a nationwide network of 115 CF care centers, which provide vital treatments and other CF resources to patients and families. For more information, visit www.cff.org.
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 a clinical trial for the treatment of metabolic disorders and being prepared for clinical trials in rheumatoid arthritis under another IND, and APOPTONE™ (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 Company’s plans for research and development in the area of cystic fibrosis, the performance of the Company and CFFT under their existing collaboration agreement as well as the parties’ ability to reach agreement regarding the clinical development path for TRIOLEX in cystic fibrosis, the anticipated timing of the clinical development of the Company’s drug candidates, 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 risks that the development of TRIOLEX (HE3286) for cystic fibrosis may not proceed due to financial, technical, commercial or other reasons; that preclinical results to date with Hollis-Eden compounds may not be predictive of future clinical results, the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to obtain regulatory approval for TRIOLEX, 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.
- Scott Rieger, Director, Corporate Communications Hollis-Eden Pharmaceuticals, Inc., (858) 587-9333
- Laurie Fink, Director of Media Relations, Cystic Fibrosis Foundation, (301) 841-2602