Pro-Pharmaceuticals, Inc., a developer of novel carbohydrate-based therapeutic compounds, today announced that Hana Chen-Walden, M.D. is presenting an update of the company's Phase II and Phase III clinical trials at the Central European Society for Anti-Cancer Drug (CESAR) Conference being held today in Frankfurt, Germany. Dr. Chen-Walden provides the company with management of clinical and regulatory activities in Europe.
Pro Pharmaceuticals received clearance from the European Medicines Agency in November 2005 to initiate a European Phase III clinical trial for second line treatment of patients with metastatic colorectal cancer. The full trial is expected to have up to 800 patients in 60 centers and consist of four arms: Irinotecan, leucovorin and 5-FU (FOLFIRI) with and without DAVANAT, and oxaliplatin, leucovorin and 5-FU (FOLFOX) with and without DAVANAT. The company plans to report interim results after 120 patients have been treated. The trial will be conducted at clinical sites in the European Union (EU) and countries outside of the EU following regulatory and ethics approval in each country. The primary endpoint is progression free survival. Secondary endpoints are response rate, time to progression, and quality of life. The Company expects to begin patient enrollment in the second quarter
The company submitted a clinical protocol to the U.S. Food & Drug Administration (FDA) in September 2005 for a Phase II open label, multi-center study of its lead carbohydrate compound DAVANAT with chemotherapeutic agent 5-FU for first line treatment of patients with cholangiocarcinoma (cancer of the bile duct). The Company plans to expand this trial to Europe and is expected to treat up to 30 patients. The primary endpoints of the study are to document a complete or partial response, rate of stable disease, safety, and progression-free survival. The Company expects to begin patient enrollment in the second quarter.
The FDA approved an application for a "compassionate use" Investigational New Drug (IND) in May 2005 to continue treating a patient for cholangiocarcinoma with liver metastases who participated in the company's Phase I trial. The patient had been treated for 13 months. In January of this year, the FDA allowed a "compassionate use" IND to treat another patient.
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