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March 24, 2015
Trefoil Therapeutics Announces the Signing of a License and Research Agreement with Florida State University for Engineered FGF-1 Derivatives


Development Program to Focus on the Treatment of Corneal Dystrophies

Trefoil Therapeutics today announced the signing of a license and research agreement with Florida State University for the development of engineered FGF-1 derivatives (eFGF-1s). This agreement gives Trefoil an exclusive license to the eFGF-1 patent estate for therapeutic and cosmetic uses.  This collaboration will advance the existing eFGF-1 technology developed by Dr. Michael Blaber, Professor at FSU and a co-founder of Trefoil.


The eFGF-1 platform represents an innovative approach to the improvement of pharmacokinetic properties of fibroblast growth factors as drugs, yielding novel FGF-1s.  These eFGF-1s have demonstrated superior pharmacodynamic and pharmaceutical properties compared to the naturally occurring FGF-1s in animal models of tissue healing.  A lead compound for development for corneal regeneration has been selected (TTHX-1014) and Trefoil is moving this compound towards an IND application.  Corneal regeneration has been shown in in vitro rabbit models.


Brent Edington, Head of the Office of Commercialization at FSU, noted that “This collaboration for the development of novel therapeutics demonstrates the strength of FSU’s research programs and the focus of scientists at FSU on research relevant to human benefit”.


“Trefoil is delighted to be able to partner with the powerful research capabilities of FSU and the Blaber laboratory for the further development of the eFGF-1 technology” said Dr. David Eveleth, CEO of Trefoil.


The first therapeutic application focuses on eliminating the most common driver of corneal transplantation, Fuchs corneal dystrophy (CED).  CED can lead to severe visual loss for which there is currently no approved pharmaceutical therapy.


“Corneal dystrophies are a category of serious, sight threatening conditions that have limited treatment options today; aside from surgical intervention” said William Trattler, MD, Director of the Center for Excellence in Eye Care, Miami, FL.  “There is a significant need for therapeutic agents that can treat or slow the progression of this category of diseases and this innovative new class of drug may significantly expand our treatment options.”


The broad family of patents covering eFGF-1s was also bolstered recently by the issuance of US patent 8,962,557, which describes additional fibroblast growth factor mutants with improved functional half-life and use methods.  Further, over the last 12 months, several other patents have been filed covering new aspects of eFGF-1 technology and strengthening the intellectual property protection for these novel therapeutics.


Trefoil also announced the addition of two new members of its team.  Schalon Newton, D.M. has been appointed Chief Business Officer and will be responsible for business development, partnering and strategy.  Schalon was the head of business development at Santen and spent more than 20 years at Allergan, including leading Allergan’s Japanese subsidiary.


William Stewart, M.D., will serve as a development consultant to Trefoil, leading the development of the clinical strategy and the initial clinical trial.  Dr. Stewart is an ophthalmologist and founder of PRN, a leading clinical ophthalmic contract research organization, and PharmaFarm which assists startups with unique innovative technology, such as Trefoil, with their development process.


About Trefoil:

Trefoil’s mission is to improve human health and create new therapies using drugs developed with protein engineering.  Trefoil hopes to bring this novel therapy into clinical testing within 18 months.  Other potential applications for the eFGFs include regenerative therapies that may address a broad range of ischemic disease, including coronary heart disease, diabetic ulcers, and peripheral artery disease.


Trefoil has received several accolades including winning the CONNECT Springboard business plan program (2013) and the Southeast Biotechnology Early Company Competition (2014).


Forward-Looking Statements

The preclinical research discussed in this press release is preliminary and the outcome of such preclinical studies may not be predictive of the outcome of later clinical trials.  Future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research findings discussed in this press release.  



For information contact:


Dr. David Eveleth, CEO

917 628 8502




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