June 24, 2008 09:00 AM Eastern Daylight Time
CARLSBAD, Calif.--(BUSINESS WIRE)--Encore Therapeutics, Inc. (“ETI”) today reported that it has created a proprietary nano-emulsion intravenous formulation of progesterone that is suitable for the treatment of stroke and traumatic brain Injury, or TBI. Both stroke and TBI are major unmet needs with 500,000 and 1.4 million new cases, respectively, reported each year in the United States and no effective treatments for either disorder.
The protective effect of progesterone in treating brain injury has been firmly established but the inability to develop a product that can be used in the field by medical first responders and the absence of intellectual property covering a composition of progesterone have prohibited commercialization. To address these deficiencies, Encore has developed ETI-411, a novel lyophilized, easy to reconstitute and administer IV progesterone formulation. The company is now seeking a development and commercialization partner to bring ETI-411 to market.
Dr. Paul J. Marangos, Chairman and CEO of ETI commented, “Treatments for stroke and TBI and have eluded the best efforts of drug development largely due to drug toxicity and lack of efficacy. Progesterone is safe and has been documented by many investigators to have broad neuroprotective efficacy in both pre-clinical and clinical studies but its commercialization has not been feasible till now. We are excited about finding a partner to commercialize ETI-411.”
ETI-411 is based on a proprietary phospholipid nano-emulsion formulation that is composed entirely of natural or generally regarded as safe, or GRAS, components. This formulation platform has been utilized successfully for a variety of other IV drugs currently in human clinical trials. Dr. Andrew X. Chen, Chief Scientific Officer and inventor of the formulation commented, “ETI-411 is a substantial improvement over the current means of delivering IV progesterone. It is supplied in a stable, lyophilized format that can be easily reconstituted and administered, making it ideal for first responders and ER personnel treating stroke and TBI victims.”
About Stroke and TBI
Stroke is the third leading cause of death in the U.S. and TBI is the leading cause of death in young people. The combined annual cost to the US healthcare system related to stroke and TBI exceeds $120 billion each year. There are no effective treatments for either disorder.
About ETI
ETI was founded by Drs. Paul J. Marangos and Andrew X. Chen in 2006 to extend and enhance the action of existing drugs through novel formulation strategies. The Company has devised multiple novel applications of its proprietary phospholipid based formulation technologies and seeks development and marketing partnerships with other companies to bring these products to market.
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