Pro-Pharmaceuticals gets an FDA OK
Pro-Pharmaceuticals Inc. of Newton said today that the US Food and Drug Administration has granted it an approval to use Davanat in a potential treatment for breast cancer patients.
Specifically, the FDA granted the company an investigational new drug application for use of Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Ky., said Pro-Pharmaceuticals, which describes Davanat as a proprietary carbohydrate drug that is administered with chemotherapies and biologics to treat cancer.
According to the company, pre-clinical studies have shown that Davanat, in combination with chemotherapy, significantly reduced tumor growth in mice implanted with metastatic human breast cancer.
In a press release, Pro-Pharmaceuticals noted that the American Cancer Society estimates that about 180,000 new cases of breast cancer will be diagnosed in the United States this year and about 45,000 deaths will occur.
Pro-Pharmaceuticals also noted that Davanat is being administered in Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.
(By Chris Reidy, Globe staff)
