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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

Company Also Announces Receipt of Fast Track Designation from FDA, Favorable Scientific Advice from EMEA and Phase 3 Plans for the Non-Small

Cell Lung Cancer Monotherapy Indication

SANTA MONICA, Calif., Feb. 26 /PRNewswire/ -- Dr. Giuseppe Giaccone, Chief of the Medical Oncology Branch at the National Cancer Institute, presented the final results from a positive double-blind, placebo-controlled Phase 2 trial with talactoferrin alfa in non-small cell lung cancer (NSCLC). The data were presented at the 2008 Targeted Therapies for the Treatment of Lung Cancer meeting in Santa Monica, California.

This was the second successful, randomized, double-blind, placebo- controlled trial with oral talactoferrin in NSCLC. The first was with talactoferrin in combination with first-line chemotherapy.

The monotherapy trial, which compared single-agent oral talactoferrin to placebo in patients with NSCLC who had failed previous chemotherapy, met its primary endpoint of improvement in overall survival. Secondary efficacy endpoints also showed improvement consistent with the primary endpoint results. Oral talactoferrin was well tolerated in this patient population with fewer adverse events observed in the talactoferrin arm. Earlier data from this trial were presented at the 2007 American Society of Clinical Oncology (ASCO) Annual Meeting, and at the 2007 World Conference on Lung Cancer Annual Meeting.

"The improvement in overall survival seen with talactoferrin monotherapy in this Phase 2 study is exciting," said Dr. Jeffrey Crawford, Chief of Medical Oncology, Duke University Medical Center, Durham, North Carolina. "Importantly, this effect was observed in a treatment-refractory patient population with few remaining therapeutic options, and talactoferrin was well tolerated with few adverse events."

Agennix also announced the receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for the clinica
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SOURCE Agennix
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