Pro-Pharmaceuticals says Davanat study accepted as abstract for American Society of Oncology meeting

By E. Janene Geiss

Philadelphia, March 17 - Pro-Pharmaceuticals, Inc. announced Friday that its abstract referring to the company's research program to better understand the mechanism of action for Davanat as a single agent and when administered in combination with 5-FU has been accepted for publication in The American Society of Cancer Oncology's 2006 Annual Meeting proceedings, which is a supplement to the Journal of Clinical Oncology.

The abstract also confirms the pharmacokinetic results from the company's phase 1 Davanat trial. The study uses radio-labeled, 5-Fluorouracil to study the bio-distribution in the bloodstream, tumor and other organs alone and when co-administered with Davanat, according to a company news release.

The phase 1 trial was designed for cancer patients with advanced solid tumors that were not amenable to surgery, radiation, or chemotherapy, were refractory to 5-FU, and had a minimum of 12 weeks to live. The objectives of the study were to determine the maximum-tolerated dose and dose-limiting toxicity of Davanat as a single agent and when administered in combination with 5-FU.

In addition to safety, the study evaluated the pharmacokinetic profile of 5-FU in the presence of Davanat and the effect of Davanat/5-FU on tumor size in patients with measurable disease. The trial stopped recruiting patients in March 2005. Preliminary phase 1 data was reported at the society's annual meeting last year, officials said. This year's meeting will be held in Atlanta in early June.

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

The company also has begun a European-based phase 3 clinical trial for second-line treatment of patients with metastatic colorectal cancer. The company also started a phase 2 open label, multi-center study of Davanat with 5-FU for first-line treatment of patients with cancer of the bile duct.

Pro-Pharmaceuticals is a Newton, Mass., development stage company engaged in the discovery, development and commercialization of carbohydrate-based therapeutic compounds to provide advanced treatment of cancer, as well as liver, microbial, cardiovascular and inflammatory diseases, and viral infections.

© 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.