Pro-Pharmaceuticals And Digna Biotech Sign Agreement To Apply DAVANAT With Novel Drugs
Newton, MA - Pro-Pharmaceuticals, Inc., a developer of first-in-class carbohydrate therapeutics, recently announced it has signed an agreement with Digna Biotech SL of Pamplona, Spain to investigate the application of the Company's carbohydrate technology platform in combination with Digna's novel drugs to improve treatment of chronic Hepatitis C infections. The investigation will evaluate the ability of carbohydrate compounds to improve the delivery of Digna's novel compounds to enhance activity against chronic Hepatitis C infections. Pro-Pharmaceuticals' lead compound DAVANAT will be the first carbohydrate compound to be evaluated as data from pre-clinical and clinical trials show that DAVANAT increased the patient's exposure to 5-FU ten-fold with no increase in toxicity.
"The collaboration with Digna is an important step in the development, commercialization and validation of our first-in-class carbohydrate technology," said David Platt, Ph.D, President & Chief Executive Officer, Pro-Pharmaceuticals, Inc. "Pharmaceutical companies continue to evaluate our technology for use with their compounds. The need to improve drug therapies, particularly anti-cancer agents, is significant and represents a large market opportunity. We believe our technology has the potential to play a major role in the worldwide treatment of patients with serious disease."
Commercialization Strategy
The Company's business objective is to develop DAVANAT initially in combination with chemotherapeutics, and subsequently to rescue drugs that were shelved for toxicity or half-life issues; to use novel carbohydrate polymers to increase the solubility of known drugs, and to develop carbohydrate polymers as new chemical entities. Commercialization may be in the form of direct distribution, sales and marketing agreements, out licensing, or partnership with a biotechnology/pharmaceutical company. The Company plans to apply this approach in the U.S. as well as in other major international markets
The Company submitted data to the U.S. Food & Drug Administration (FDA) to allow DAVANAT to be used as a functional excipient intravenously with 5-FU, for cancer applications for a filing under Section 505 (b)(2). The Company is using Section 505 (b)(2) to obtain more timely and efficient marketing approval of new formulations of previously approved therapeutics. The FDA requested additional chemistry, manufacturing and controls data. The Company plans to file a Master Drug File as soon as it completes the additional manufacturing information needed. 5-FU is one of the most widely used chemotherapy drugs in the world and is used to treat various types of cancers, including colorectal, breast and gastrointestinal.
The Company also plans to file a New Drug Application for DAVANAT when it completes the two ongoing Phase II trials for first line treatment of colorectal and advanced biliary cancers and then conducts a pivotal Phase III trial.
In addition to DAVANAT, the Company is developing a pipeline of carbohydrate-based therapeutic compounds that address other chronic diseases that are currently in the pre-clinical stage of development. The Company is testing a library of products—carbohydrate derivatives of marketed chemotherapeutics and biologics, including doxorubicin, irinotecan, oxaliplatin, cisplatin, paclitaxel, and bevacizumab. The Company is using its carbohydrate technology platform to develop novel anti-fibrosis (scarring of the liver) drugs through a research collaboration with Mount Sinai School of Medicine. The Company continues to develop and expand its pipeline of carbohydrates drug candidates in combination with other therapeutics and biologics for various indications.
About DAVANAT
DAVANAT, the Company's lead drug candidate, is a polysaccharide (carbohydrate polymer) composed of mannose and galactose (galactomannan). The Company believes DAVANAT's mechanism of action is based upon binding to lectins on the surface of cells. It is theorized that DAVANAT targets specific lectin receptors (Galectins) that are over-expressed on cells. Current research indicates that Galectins affect cell development and play important roles in cell survival. This form of targeted delivery may allow for higher doses of drug administration with no increase in toxicity.
SOURCE: Pro-Pharmaceuticals, Inc. and Digna Biotech SL