February 24, 2006

Pro-Pharmaceuticals has reported an update on Phase II and Phase III clinical trials at the Central European Society for Anti-Cancer Drug (CESAR) Conference, held in Frankfurt, Germany.

The company 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 with and without Davanat, and oxaliplatin, leucovorin and 5-FU 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 EU and countries outside of the EU following regulatory and ethics approval in each country.

The company also submitted a clinical protocol to the FDA in September 2005 for a Phase II open-label, multicenter 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.