Pro-Pharmaceuticals, Inc. has retained Camargo Pharmaceutical Services to provide strategic regulatory support for the company’s 505(b)(2) submissions for Davanat with the FDA. Camargo’s regulatory support includes the preparation and submission of NDAs, aNDAs, and 505(b)(2) NDAs to help expedite the regulatory submission and approval process for clients.

“Our goal is to get Davanat to market in a timely manner with multiple chemotherapy drugs,” stated David Platt, Ph.D., chief executive officer, Pro-Pharmaceuticals, Inc. “We submitted pre-clinical and clinical data to the FDA that demonstrates Davanat improves 5-FU. In other preclinical studies, Davanat also improved activity of FDA-approved chemotherapeutics, such as Irinotecan, Oxaliplatin, Cisplatin, Avastin, Taxol and Doxorubicin.”

The company has submitted data to begin 505(b)(2) filings for Davanat as a functional excipient to be co-administered intravenously with 5-FU to treat cancer. The functional excipients are important as a drug target delivery to reduce toxicity and/or increase efficacy.