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RGN-259

RegeneRx Biopharmaceuticals, Inc.

Drug Names(s): GBT-201, thymosin beta 4 (TB4) peptide

Description: RGN-259 is based on the thymosin beta 4 (TB4) peptide. TB4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. It exhibits a number of properties important to the wound healing cascade such as promoting endothelial cell differentiation and cell migration, down-regulating a number of inflammatory cytokines and chemokines, and inducing collagen deposition.

TB4 may have several targets involved. There is evidence that F1-F0 ATP synthase is the extracellular target. Binding increases cell surface ATP levels and signaling through the purinergic P2X4 receptor.

Intracellularly, TB4 is involved in opposing effects on cell migration. On the one hand, it binds to and sequesters actin monomers (G-actin), inhibiting actin polymerization and cell migration. However, at the leading edge of migrating endothelial cells, profilin leads to disassociation of TB4 and actin, and TB4 forms a complex with integrin linked kinase (ILK) and AKT2. This leads to activation of AKT2 and consequent metalloproteinase-2 production. Hence, in this latter set of events, TB4 coordinates actin polymerization with metalloproteinase synthesis to promote endothelial cell motility.

Deal Structure: RegeneRx and Defiante
In January 2004, RegeneRx announced that it has exclusively licensed certain European rights to T4. Under the agreement, Defiante Farmaceutica, Lda, a wholly-owned subsidiary of Sigma-Tau Group, will develop T4 for internal and external wounds in Europe and certain other contiguous and geographically relevant countries.

Under the Agreement, Defiante will pay RegeneRx a royalty on commercial sales and will purchase all required T4 from the Company. When RegeneRx completes positive Phase II clinical trials in the United States, Defiante must either pay the Company $5 million or initiate pivotal Phase III clinical trials in Europe to maintain the license. Defiante also will be obligated to attain future clinical and regulatory milestones in the licensed territory. As those milestones are obtained, certain performance criteria regarding commercial registration and minimum annual royalties will be required in each licensed country. The agreement does...See full deal structure in Biomedtracker

Partners: Sigma-Tau S.p.A. Lee's Pharmaceutical Holdings Limited


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