Temple University School of Medicine
Microbiology Research
Monday, March 14, 2011
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Temple University would like to explore a strategic commercialization pathway for a proprietary transdermal delivery system for the steroid Fluasterone, a non-androgenic analog of the adrenal hormone DHEA. In preclinical models, DHEA is effective in treating symptoms of the metabolic syndrome (obesity, insulin resistance, elevated triglycerides) and also has potent anti-inflammatory activity in models of arthritis, multiple sclerosis, and psoriasis. DHEA is significantly androgenic, which has greatly limited its pharmaceutical development. The steroid Fluasterone, which in addition to lacking the androgenicity of DHEA, is 4-6X as potent in preclinical models. Fluasterone has completed four Phase 1-2 clinical trials with oral capsules and one phase 1-2 trial with a buccal formulation. Fluasterone significantly lowered fasting plasma triglycerides in hypertriglyceridemic patients and was particularly effective in individuals with metabolic syndrome. Preliminary data also indicate that Fluasterone lowers fasting plasma glucose in individuals with impaired fasting glucose.
Temple has found that DHEA and Fluasterone undergo extensive first-passage metabolism following oral administration. By contrast, parenteral, buccal, and transdermal administration do not suffer from this loss of activity and moreover, transdermal administration is about 40X as potent as oral. Neither daily injections nor buccal tablets (requiring 4 relatively large tablets) are likely to receive patient compliance, and it plans to administer Fluasterone with a novel transdermal delivery system. Fluasterone works through a unique mechanism, distinct from existing anti-diabetic and anti-inflammatory drugs. Temple plans to develop a Fluasterone transdermal formulation for the treatment of type 2 diabetes as well as a topical treatment for pain associated with osteoarthritis in joints of the hand and knee.
3 Major Issues
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How to obtain and subsequently leverage the past pre-clinical and clinical data in order to fast track the commercialization of the transdermal formulation of Fluasterone?
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To do a startup or a license – the better commercialization pathway?
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Given the multiple therapeutic applications of Fluasterone in animals (vet) and humans, how do we determine a business development strategy that extracts the maximum value of the underlying proprietary invention?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Arthur G. Schwartz, Ph.D., Professor, Department of Microbiology, Temple University School of Medicine, will deliver the Company's "Elevator" Pitch to the Group
8:20 - A Panel will address 3 Major Issues for the Company
9:00 - Open discussion: members and guests
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