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SURVIVAL BENEFIT DEMONSTRATED IN PLACEBO-CONTROLLED TRIAL IN PATIENTS WITH REFRACTORY NON-SMALL CELL LUNG CANCER TREATED WITH AGENNIX'S ORAL TALACTOFERRIN Data from the Randomized, Double-Blind, Placebo-Controlled Phase II Trial Presented at ASCO Houston June 4, 2007 Agennix Incorporated today announced results from a fourth positive Phase II trial with its lead molecule talactoferrin alfa, an immunomodulatory protein with a novel mechanism of action. This trial, which compared oral talactoferrin monotherapy to placebo in patients with refractory non-small cell lung cancer (NSCLC), met its primary endpoint of a statistically significant 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. These data were presented Saturday, June 2, at the 2007 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Oral talactoferrin significantly improved overall survival in this study. In the 100-patient intent-to-treat (ITT) population, median overall survival was 62% higher in the talactoferrin group than in the placebo group 6.0 months versus 3.7 months, respectively (hazard ratio=0.69; p=0.0476). In the 81-patient prospectively-defined evaluable population, the median overall survival was 73% higher in the talactoferrin group than in the placebo group 7.6 months versus 4.4 months, respectively (hazard ratio=0.60; p=0.0213). The six-month survival rate in the ITT population was also significantly better in the talactoferrin group (49%) than the placebo group (28%), p=0.0276. In addition, overall survival improvement trends were consistent across subsets of patients grouped by prognostic factors, including disease stage, performance status, and line of therapy. In addition to improving overall survival, oral talactoferrin was well tolerated by refractory NSCLC patients. Adverse events (AEs) were generally mild, and no drug-related serious AEs were reported. In addition, there were 28% fewer AEs and 51% fewer Grade 3/4/5 AEs in the talactoferrin group relative to the placebo group (p=0.0015 and p=0.0005, respectively). This was the second successful placebo-controlled trial with oral talactoferrin in NSCLC. The first was in combination with first-line chemotherapy. Preparations for Phase III trials with talactoferrin are underway in both NSCLC indications: (i) first-line in combination with chemotherapy, and (ii) single-agent treatment of patients with refractory disease. About the Study About Talactoferrin Alfa Both oral and topical formulations of talactoferrin appear to be well tolerated. Over 600 patients have been dosed with talactoferrin, including patients who had exposure to talactoferrin lasting over two years, without any drug-related serious AEs. About NSCLC NSCLC accounts for approximately 80% of all new lung cancer cases, with approximately 150,000 patients in the United States and 300,000 patients in Europe diagnosed each year. Most patients diagnosed with NSCLC have late-stage disease (Stage IIIB or IV), which is not surgically resectable. The current U.S. standard of care for these patients is systemic chemotherapy. Even with the available therapy, the five-year survival rate for these patients is less than 3%. About Agennix More information about Agennix is available on the Company's web site at http://www.agennix.com. |
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