Monday, September 15, 2008

Pro-Pharmaceuticals to extend Davanat to treat colorectal cancer

By Mass High Tech Staff

Newton-based Pro-Pharmaceuticals Inc. has submitted a New Drug Application to the U.S. Food and Drug Administration for its Davanat chemical treatment for advanced colorectal cancer.

The company already has submitted a Drug Master File for the carbohydrate compound to indicate which treatments it can work with effectively. The DMF listed among its acceptable combinations in lowering chemotherapy toxicity 5-FU, Irinotecan, Oxaliplatin, Cisplatin, Avastin, Taxol and Doxorubicin.

The plan in submitting a New Drug Application to the FDA is to commercialize Davanat in 2009, according to Pro-Pharmaceuticals (AMEX: PRW) president Theodore Zucconi. Davanat is a carbohydrate compound that binds to lectin receptors on cancer cells.

Last week, the company sent clinical and preclinical data to the FDA for a pre-investigational new drug meeting scheduled for Oct. 8, at which the company will present its plan to develop an anti-hypoxia drug to be used in combination with Davanat and 5-FU to treat advanced solid tumors. The plan is in response to studies that indicate a tumors’ resistance to chemotherapy and radiation is linked to hypoxia, a condition in which there is a decrease in the oxygen supply to a tissue. Many tumors contain a significant number of hypoxic cells, due to insufficient numbers of blood vessels, officials said. The reduction in oxygen within tumors confers resistance to both radiotherapy and chemotherapy, and in many cases correlates with a poor prognosis.

And late last month, the FDA granted Pro-Pharmaceuticals a new-drug application for using Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Ky.

Pro-Pharmaceuticals reported a net loss of $2 million for the first quarter of 2008 on no revenue, following a net loss of $9.4 million of zero revenue in 2007.