Pro-Pharmaceuticals, Inc, a company developing targeted therapeutic compounds to treat cancer and fibrosis, announced the receipt of the manufacturing and certification data for Davanat from SAFC, the custom manufacturing services division of Sigma-Aldrich.
The manufacturing and validation data is under final independent audit and is needed for registration of a pharmaceutical ingredient. The company plans to submit the Drug Master File (DMF) shortly to the US Food and Drug Administration (FDA). The DMF submission is an important step in the company's plan to file a New Drug Application (NDA) for Davanat later this year.
The FDA responded in a letter last year to questions from the company to discuss the submission of an NDA for Davanat to treat cancer patients. The FDA recommended that the company provide the chemistry, manufacturing and controls (CMC) information necessary to support an NDA submission.
"We and Camargo Pharmaceutical Services are performing a final audit of the many documents required to comply with the FDA guidelines," said Theodore D Zucconi, president. "The complete file will be sent to the FDA as soon as the audit is complete. This is an important milestone in the process of applying for approval to sell and market Davanat. SAFC plans to continue to support the company to ensure it can advance as efficiently as possible through the NDA process and on to FDA approval".
Camargo Pharmaceutical Services, LLC provides strategic regulatory support for the company's clinical development and submission with the FDA. Camargo's expertise in regulatory affairs includes the preparation and submission of NDAs. Camargo's capabilities can expedite the regulatory submission and approval process.
"The DMF submission is an important step in our accelerated commercialization strategy for Davanat," said Eliezer Zomer, executive vice president product development and manufacturing. "We are excited to be working with SAFC and Camargo as their experience and proven track record will enable us to file our DMF in a timely manner, within FDA guidelines."
Davanat, the company's lead pipeline candidate, is a polysaccharide polymer comprised of mannnose and galactose. The results from a completed phase ll clinical trial for end-stage colorectal cancer patients, whose disease progressed after being treated with all other therapies, showed that Davanat extended median survival by 6.7 months or 29 weeks after all other treatments were exhausted. The company is currently conducting phase II trials for first-line treatment of colorectal and biliary cancer.