Pro-Pharmaceuticals updates Davanat trials at cancer drug research conference

By Lisa Kerner

Erie, Pa., Feb. 24 - Pro-Pharmaceuticals, Inc. presented an update of its phase 2 and phase 3 clinical trials on Friday at the Central European Society for Anti-Cancer Drug Conference in Germany.

Pro-Pharmaceuticals said it received clearance from the European Medicines Agency in November to begin a European phase 3 clinical trial for second-line treatment of patients with metastatic colorectal cancer.

The company expects to begin enrolling the first of up to 800 patients in the second quarter, according to a news release.

Pro-Pharmaceuticals said the study will 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.

Davanat is a proprietary polysaccharide polymer that enables the target delivery of chemotherapy drugs to protein receptors (lectins) on cancer cells.

The primary endpoint of this phase 3 trial is progression-free survival, with secondary endpoints of response rate, time to progression and quality of life.

Pro-Pharmaceuticals submitted a clinical protocol to the Food and Drug Administration in September for a phase 2 open-label, multi-center study of Davanat with chemotherapeutic agent 5-FU for first-line treatment of cholangiocarcinoma (cancer of the bile duct).

This trial of up to 30 patients is expected to expand to Europe, with enrollment slated for the second quarter, the release said.

The primary endpoints of the phase 2 study are to document a complete or partial response, rate of stable disease, safety and progression-free survival.

Pro-Pharmaceuticals is continuing its FDA-approved treatment of a patient for cholangiocarcinoma with liver metastases who participated in the company's phase 1 trial.

The company has an ongoing phase 2 clinical trial of Davanat/5-FU for third- and fourth-line treatment of colorectal cancer patients that are refractory to chemotherapy, including 5-FU.

Fifteen patients have been dosed to date at three clinical sites.

Newton, Mass.-based Pro-Pharmaceuticals develops carbohydrate-based therapeutic compounds.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.