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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

n (FDA) for the same indication.

Final Phase 2 Study Results

The Phase 2 talactoferrin monotherapy trial was an open label, 44-patient, single arm trial conducted at six leading U.S. sites. To be eligible, patients with histologically confirmed metastatic or unresectable RCC had to have disease progression after being treated with at least one prior regimen of systemic therapy. Computed tomography (CT) scan documentation of disease progression following the most recent therapy was required. Talactoferrin was administered at a dose of 1.5 grams twice a day in 14-week cycles (12 weeks on, two weeks off) for up to four cycles or until disease progression. The study's co-primary endpoints were to detect an increase in the 14-week progression-free survival (PFS) rate from 20% to 40% or a 12.5% response rate, either of which were considered to be clinically significant. In a Phase 2 trial of Avastin in second line RCC patients, the placebo arm had a 4-month PFS rate of 20%, and was chosen as the historical reference.

All 44 patients were included in the intent-to-treat (ITT) population. The study met the pre-defined target with a 14-week PFS rate of 59% (p<0.0001 for comparison to 20%). The response rate was 4.5%, with 70.5% of patients demonstrating stable disease for at least 8 weeks. The disease control (complete or partial response + stable disease) rate was 75%. The median PFS was 6.4 months. The median overall survival (OS) was 21.1 months, and the 1 year survival rate was 77%. Talactoferrin was well tolerated with no significant hematological, renal or hepatic toxicities reported. In addition, there were no drug related serious adverse events.

About EMEA Orphan Medicinal Product Designation

The Regulation on Orphan Medicinal Products in the European Union (EU) provides incentives for companies developing and marketing therapies for rare diseases, defined as those affecting fewer than five in 10,000 people in the EU. The Regulation
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