A -- Development and Commercialization of Bcl-XL Fusion Proteins to Inhibit Neuron Apoptosis in vivo for the Treatment of Spinal Cord Injury or Stroke

The National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) seeks a Cooperative Research and Development Agreement (CRADA) Collaborator to work with NINDS in the development, manufacture and commercialization of Bcl-XL fusion proteins that inhibit apoptosis in neurons. NINDS is seeking a development and commercialization partner for GMP production and in vitro and in vivo testing of Bcl-XL fusion proteins. Potential Areas of Application - Treatment of spinal cord injury - Treatment of stroke Main Advantages of Technology/Invention: - Bcl-2 family of proteins is potent regulators of apoptosis. We have developed a protein-based Bcl-XL delivery system that increases the cellular levels of Bcl- XL and prevents neuron apoptosis in vitro and in vivo. For transient apoptotic insults such as spinal cord injury and stroke, the protein may be delivered to minimize neuron loss. As Bcl- XL prevents apoptosis upstream of caspases, mitochondrial permeabilization and all knows steps of apoptosis this approach should offer the best long term rescue of neurons and offer important therapeutic benefit to spinal cord injury patients. Stroke also may be a candidate for such a therapy to block acute apoptosis. Current State of Development - In vitro studies indicate that Bcl- XL fusion proteins inhibit apoptosis in many cell types induced by a variety of insults (PNAS 96: 9563-9567, 1999). - In vivo studies indicate that Bcl- XL fusion proteins prevent neuron apoptosis in several trauma models (J. Biol. Chem. 276:46326-32, 2001). Further R&D Required: - Produce GMP quality Bcl-XL fusion protein - Screen Bcl-XL fusion protein for activity in vitro or in vivo - Plan for clinical trials of Bcl-XL fusion proteins Patent Status: - Patent pending ( published as WO 01/12661) - Licensing of technology available Submission Dates: - Letter of interest should be received by March 15, 2003. Proposals will be reviewed in order of receipt Contact Information: - Martha T. Lubet Ph.D. NINDS Technology Transfer by TTB/ NCI Phone:+1 (555) 000-0000 E-mail contact@example.gov