Results Published in the Journal 'Cancer' Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell...( HOUSTON July 1 /- Agennix Incorpo...),Health

HOUSTON, July 1 /PRNewswire/ -- Agennix Incorporated today announced the publication of final results from a Phase 2 monotherapy trial with talactoferrin alfa in patients who had failed previous treatment for advanced or metastatic renal cell carcinoma (RCC). Results from the study, which were reported in the July 1 issue of the journal 'Cancer' (volume 113, number 1), demonstrate that talactoferrin is active in RCC, has a favorable toxicity profile, and is a promising candidate for further study in this disease.

The talactoferrin monotherapy single arm trial was conducted at six leading U.S. centers and enrolled 44 patients who had all failed prior treatment for advanced or metastatic RCC. The study met the pre-defined target of demonstrating an improvement in the fourteen week progression-free survival (PFS) rate relative to published results in this population. Additional evidence of anti-cancer activity included the occurrence of partial responses and an apparent increase in median PFS and median overall survival (OS) relative to published results. As in previous studies with talactoferrin, the drug was well tolerated.

"The results seen with talactoferrin monotherapy in this Phase 2 trial are promising," said Dr. Eric Jonasch, Assistant Professor, MD Anderson Cancer Center, Houston, Texas, and the first author of the study. "The trial results indicate that additional studies of talactoferrin in patients with RCC are warranted either as a single agent or in combination with one of the newer targeted therapies. Previously conducted preclinical studies combining talactoferrin with sunitinib are supportive for examining this combination in a randomized trial in patients with advanced or metastatic RCC."

Agennix also announced the receipt of Orphan Medicinal Product designation from the European Medicines Agency (EMEA) for RCC. The Company had previously announced receipt of Orphan Drug designation from the U.S. Food and Drug Administratio
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