Pro-Pharmaceuticals Inc., a developer of novel first-in-class carbohydrate compounds, received comments from the US Food and Drug Administration (FDA) relative to its plans for submitting a New Drug Application (NDA), under Section 505 (b) for Davanat, as a functional excipient, to be co-administered with 5-Fluorouracil (5-FU) to treat cancer patients.
"In March, we sent the FDA substantial information on chemistry and completed pre-clinical and clinical data, along with a list of questions to submit an NDA 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)," said David Platt, Ph.D., president and CEO, Pro-Pharmaceuticals Inc.
"The letter response from the FDA was in line with our expectation. The FDA's response provides us with a clear roadmap in terms of what additional information, primarily manufacturing, they need to allow our NDA submission. No additional toxicology or clinical tests or trials are required. We plan to file an NDA submission as soon as we complete the additional manufacturing information needed."
Davanat, the company's lead product 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 cancer cells. Lectins are carbohydrate-binding proteins found on cell surfaces. 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 tumour cell survival, angiogenesis and tumour metastasis.