Pro-Pharmaceuticals Announces DAVANAT Regimen Approved To Treat Breast Cancer Patient

15.04.2008 at 08:00 - Category: Cancer and Oncology

Pro-Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of DAVANAT(R) in combination with chemotherapy and biologic to treat a breast cancer patient. The Company currently has two ongoing Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.

The American Cancer Society estimates that approximately 180,000 new cases of breast cancer will be diagnosed in the United States this year and approximately 45,000 deaths will occur.

Pre-clinical studies showed that DAVANAT(R), 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(R) in combination with Avastin(R) and 5-FU also lowered toxicity as indicated by the weight gain of the mice in the study. Avastin(R) recently has been approved for treating breast cancer in combination with chemotherapy.

"Our goal is to improve the clinical benefit for patients being treated with chemotherapy by extending their lives and improving their quality of life," said Theodore Zucconi, President, Pro-Pharmaceuticals. "We are pleased that the FDA has approved the use of DAVANAT(R) to treat a breast cancer patient. Our clinical and pre-clinical data support the fact that DAVANAT(R) extends survival with fewer side effects when used with chemotherapies and biologics. The need to improve drug therapies, particularly anti-cancer agents is significant and represents a large market opportunity. This is the third cancer indication for which we have received a compassionate use IND approval."

As recently reported, data from a Phase II trial for end-stage colorectal cancer patients showed DAVANAT(R) extended median survival by 6.7 months with significantly reduced levels of toxicity. 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. The data for the 20 patients revealed that three patients survived more than one year, two patients survived more than two years and one patient is still alive.

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Pro-Pharmaceuticals Announces DAVANAT Regimen Approved To Treat Breast Cancer Patient