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Oral Talactoferrin Alfa Improves Overall Survival in Patients With Refractory Non-Small Cell Lung Cancer: Final Phase 2 Study Results Presented at the 8th Annual Targeted Therapies for the Treatment Of Lung Cancer Meeting
Date:2/26/2008

-free survival, confirmed response rate, duration of response, disease control rate and safety.

The Phase 3 NSCLC monotherapy trial will be conducted concurrently with the pivotal Phase 3 first-line combination with chemotherapy NSCLC trial. Both studies will be conducted at many of the same sites and in partnership with the same global contract research organization (CRO). The first-line Phase 3 trial is also supported by a positive double-blind, placebo-controlled Phase 2 trial. For the first-line indication, Agennix has been granted a Special Protocol Assessment and Fast Track designation from the FDA, and has received favorable Scientific Advice from the EMEA. Both Phase 3 studies are expected to be active and recruiting in mid-2008.

FDA Fast Track Designation and EMEA Favorable Scientific Advice

Agennix received Fast Track designation from the FDA for the clinical development of talactoferrin as a single-agent in patients with locally advanced or metastatic NSCLC who have failed at least two prior systemic anti- cancer therapies. The Company had previously received Fast Track designation for first-line treatment of NSCLC in combination with chemotherapy.

Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and address unmet medical needs. The NSCLC monotherapy Fast Track designation was granted based on positive, randomized, placebo-controlled Phase 2 results with oral talactoferrin, and the planned Phase 3 pivotal trial.

"We are very pleased that the FDA recognizes that our lead product, talactoferrin alfa, also has potential as a single-agent treatment for patients with NSCLC who have failed previous therapies and who currently have very few options," said Dr. Rajesh Malik, Chief Medical Officer of Agennix.

Agennix also received Scientific Advice from the EMEA indicating that the planned single pivotal Phase 3 global trial with talactof
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SOURCE Agennix
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