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Results Published in the Journal 'Cancer' Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell Carcinoma
Date:7/1/2008

grants companies with Orphan Medicinal Product designation market exclusivity for a particular indication for a period of ten years following Marketing Authorization Approval by the EMEA. Orphan Medicinal Product designation also facilitates the drug development process by providing companies with protocol assistance, clinical trial support, direct access to the Centralized Procedure, grant funding for research, and waiver or reduction of application fees.

The Company had previously received Orphan Drug designation for RCC from the U.S. FDA.

"We are very pleased that the EMEA recognizes that our lead product, talactoferrin alfa, has potential as a treatment for patients with RCC, and we are planning additional trials in this indication including a randomized, placebo-controlled Phase 2b trial of talactoferrin in combination with a standard first-line therapy," said Rajesh Malik, M.D., Chief Medical Officer of Agennix.

About the Planned Phase 2b First-Line Combination Therapy RCC Trial

Building on the results of the positive Phase 2 trial with single agent talactoferrin, preparations are underway to conduct a Phase 2b trial in 200-250 previously untreated patients with advanced or metastatic RCC as part of a first-line combination therapy regimen. Patients will be randomly assigned to receive a standard therapy plus either oral talactoferrin or placebo. The primary endpoint will be assessment of PFS, with additional endpoints including response rate, OS, and safety.

About Talactoferrin Alfa

Talactoferrin, a novel dendritic cell recruiter and activator (DCRA), is a unique recombinant form of human lactoferrin, an important immunomodulatory protein.

In 1988, scientists at Baylor College of Medicine, Houston, Texas, discovered a way to produce this protein in the laboratory, thus paving the way for testing its potential to help fight serious diseases that cause enormous suffering worldwide.

Lactoferrin, found in t
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SOURCE Agennix Incorporated
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