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news.Pro-Pharmaceuticals, a development stage company focused on the treatment of cancer, liver, microbial and inflammatory diseases, has announced that the FDA has granted 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, Kentucky.
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Pre-clinical studies have shown that Davanat, in combination with chemotherapy, significantly reduced tumor growth in mice implanted with metastatic human breast cancer. Results from similar pre-clinical 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.
Davanat is also being administered in Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.
Eliezer Zomer, executive vice president, product development & manufacturing at Pro-Pharmaceuticals, said: “As recently reported, data from a Phase II trial for end-stage colorectal cancer patients showed Davanat extended median survival to seven months with significantly reduced levels of side effects.
“Additionally, the data showed no apparent change from the baseline measurements in clinical blood test parameters including platelets and white blood cell counts. Reduced toxicity data indicates improved quality of life.”