DavanatTreatment for Targeted Drug Delivery
Pro-Pharmaceuticals' Begins Process of New Drug Application Submission with the FDA for Co-administration of Davanat with 5-FU in Cancer Patients
NEWTON, Mass., February 7, 2007 - Pro-Pharmaceuticals, Inc., a developer of novel carbohydrate compounds, today announced it has begun the process of submitting a New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) for co-administration of Davanat with 5-Fluorouracil (5-FU) for treatment in cancer patients.
"Our goal is to get our lead compound, Davanat to market," said David Platt, Ph.D., President & Chief Executive Officer, Pro-Pharmaceuticals, Inc. "Based on recent data analysis from our Phase l and Phase ll clinical trials, we believe Davanat has the potential to improve the pharmacokinetic profile of 5-FU, as well as other FDA-approved anti-cancer drugs, with out increasing toxicity markers as would be expected with increased 5-FU exposure. In addition, we continue discussions with pharmaceutical companies who are evaluating our technology. Our goal is to facilitate collaborations that will enable us to get our compounds to market quickly in multiple indications and modalities."
Analysis of the pharmacokinetic data of the Phase l clinical trial indicates that 5-FU, in combination with Davanat, remained longer in the bloodstream (up to 10 times), without increasing 5-FU's toxicity in these fragile patients. Increased exposure to 5-FU may explain why 54% (14 of 26) of the end-stage cancer patients, who had measurable disease, were stabilized from 2 to 13 months and 70% (7 of 10) were stabilized at the highest Davanat dose level. In the Phase ll clinical trial for end stage cancer patients, patients had no increase in toxicity with increased exposure to 5-FU in the presence of Davanat.
The Company is actively recruiting and dosing patients in two international Phase ll trials both designed as first-line therapies in colorectal and biliary cancers, administering Davanat in combination with 5-FU. In the colorectal trial, AVASTIN and Leucovorin are also administered. Additional information on these two trials can be found at www.clinicaltrials.gov.
Davanat, the Company's lead drug candidate, is a carbohydrate (polysaccharide) polymer composed of mannose and galactose. The Company believes Davanat's mechanism of action is based upon binding to lectins on the cell surface. Lectins are carbohydrate-binding proteins found in increased amounts on cell surfaces. Davanat, when injected into humans, recognizes and attaches to lectins. It is theorized that Davanat targets specific lectin receptors (Galectins) that are over-expressed on cancer cells. Current research indicates that Galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis and tumor metastasis. This form of targeted delivery may allow for higher doses of chemotherapy administration with no increase in toxicity.
Source: Pro-Pharmaceuticals, Inc.
Posted: February 2007
- Pro-Pharmaceuticals Submits Data to FDA for Davanat NDA to Treat Advanced Colorectal Cancer - September 15, 2008
- Pro-Pharmaceuticals Announces Submission of Drug Master File for Davanat to FDA - May 20, 2008
- Pro-Pharmaceuticals Updates NDA Filing for Davanat - May 1, 2008
- Pro-Pharmaceuticals Selects SAFC, a Division of Sigma-Aldrich, to Submit a Drug Master File - December 19, 2007
- Pro-Pharmaceuticals Submits Data to Begin a 505 (b)(2) Filing with the FDA for a New Formulation of Irinotecan to be Co-administered with Davanat as a Functional Excipient - June 11, 2007
- Pro-Pharmaceuticals Receives Letter from the FDA for New Drug Application for Davanat/ 5-FU - April 11, 2007