Hollis-Eden Pharmaceuticals Announces Cystic Fibrosis Foundation Therapeutics Selects TRIOLEX (HE3286) As A Next-Generation Oral Anti-Inflammatory Drug Candidate
San Diego CA - Hollis-Eden Pharmaceuticals, Inc., the leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, recently 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.
SOURCE: Hollis-Eden Pharmaceuticals, Inc.