Pro-Pharma's Davanat gets IND from FDA
The US Food and Drug Administration has granted an Investigational New Drug application for the use of Pro-Pharmaceuticals' Davanat, a carbohydrate (polysaccharide) polymer composed of mannose and galactosein combination, with 5-fluorouracil to treat a breast cancer patient at the Brown Cancer Center in Louisville, Kentucky. The drug is also being administered in Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.
The American Cancer Society estimates that around 180,000 new cases of breast cancer will be diagnosed in the USA this year and some 45,000 deaths will occur.
Preclinical studies showed that Davanat, in combination with chemotherapy, significantly reduced tumor growth in mice implanted with metastatic human breast cancer. Results from similar preclinical studies designed to optimize formulations of Davanat and 5-FU also lowered toxicity as indicated by the weight gain of the mice in the study.
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