FDA News

Pro-Pharmaceuticals Submits Data to Begin a 505 Filing with the FDA for a New Formulation of Irinotecan

(June 11, 2007)-- Pro-Pharmaceuticals, a Company “Advancing Drugs Through Glycoscience”, today announced it has submitted data to begin a filing under Section 505 (b)(2) with the U.S. Food & Drug Administration (FDA), for a new formulation of Irinotecan to be co-administered with DAVANAT®, as a functional excipient, to treat cancer.

The Company is using Section 505 (b)(2) to obtain more timely and efficient marketing approval of new formulations of previously approved therapeutics which incorporate the Company’s proprietary drug target delivery compound. The Company is seeking approval for co-administration of DAVANAT with FDA-approved Irinotecan for intravenous injection for the treatment of cancer. In pre-clinical studies, DAVANAT has demonstrated it significantly improves Irinotecan activity in the tumor as measured by tumor shrinkage and reduced toxicity.

“Our goal is to get our lead compound, DAVANAT to market with multiple chemotherapy drugs,” said David Platt, Ph.D., President & Chief Executive Officer, Pro-Pharmaceuticals, Inc. “We submitted pre-clinical data to the FDA that demonstrates DAVANAT improves Irinotecan efficacy on tumor and toxicology data. In other pre-clinical studies, DAVANAT also improved FDA-approved chemotherapeutics, such as 5-FU, Oxaliplatin, Cisplatin, Avastin®, Taxol and Doxorubicin.”

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