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Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma
Date:5/19/2009

HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer).

The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permit the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review which may result in an abbreviated review time of six months.

Additional Clinical Updates

Agennix also announced that two pivotal Phase III trials in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) are underway at a number of leading U.S. clinical sites. FORTIS-M is a randomized, placebo-controlled, 720-patient trial of talactoferrin monotherapy in patients with Stage IIIB/IV NSCLC. Patients who have failed two or more prior systemic anti-cancer therapies will be randomly assigned (2:1) to receive either oral talactoferrin or placebo in additional to standard supportive care. The trial is designed to detect an improvement in overall survival in patients receiving talactoferrin, and results are expected in 2011.

FORTIS-C is a randomized, placebo-controlled trial evaluating 1100 chemo-naive NSCLC patients. Newly diagnosed patients with Stage IIIB/IV NSCLC will be randomly assigned (1:1) to receive standard first-line chemotherapy with carboplatin and paclitaxel plus either oral talactoferrin
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