AGENNIX'S TLF RECEIVES ORPHAN DRUG DESIGNATION FOR RCC

Agennix announced that the FDA has granted orphan drug designation to the company's oral formulation of Talactoferrin Alfa (talactoferrin or TLF) for the treatment of renal-cell carcinoma (RCC).

Oral TLF is currently in Phase II clinical development for RCC. Results from a multicenter Phase II RCC trial that included six leading U.S. cancer centers were presented at the 2006 Annual meeting of the American Society of Clinical Oncology.

Talactoferrin Alfa is a unique recombinant form of human lactoferrin, an immunomodulatory protein. Talactoferrin acts by binding to specific receptors found on target cells and inducing the production of key immunomodulatory cytokines and chemokines. Orally administered talactoferrin binds to enterocytes lining the upper gastrointestinal tract, initiating an immunostimulatory cascade in the gut associated lymphoid tissue.

Orphan drug designation provides incentives for companies developing and marketing therapies for rare diseases, defined as those affecting fewer than 200,000 Americans. The Orphan Drug Act grants orphan drug companies market exclusivity for a period of seven years following FDA approval. The designation also facilitates the drug development process by providing companies with protocol assistance, clinical trial support, tax credits, grant funding for research and exemption from the Prescription Drug User Fee Act filing fee.

Agennix also recently received FDA fast-track designation for the clinical development programs for oral TLF solution in first-line non-small-cell lung cancer and topical TLF gel in diabetic foot ulcers.