DAVANAT® Extends Survival for End-Stage Colorectal Cancer Patients

NEWTON, Mass. -- Pro-Pharmaceuticals, Inc. announced that new data of 14 end-stage colorectal cancer patients from its Phase II trial showed that DAVANAT® extended median survival by more than six months. The company tracked these patients and gathered data after they left the trial. The patients entered the trial with disease that progressed despite previously being treated with standard chemotherapies and biologics such as AVASTIN® and/or ERBITUX®.

Two patients survived more than two years and one patient is alive today. The interim data is for 14 of 20 patients who were enrolled in the trial. The company is in the process of gathering data on the other six patients.

As previously reported, data from the Phase II trial for all 20 end-stage patients indicated that DAVANAT®, in combination with 5-FU, extended median progression-free survival to 8.4 weeks.

Progression-free survival is a predictor of extended survival.

The data also revealed a significantly reduced level of toxicity as measured by serious adverse events (SAEs). Additionally, the data showed no apparent change from the baseline measurements in any clinical parameter including platelets and white blood cell counts. Safety data indicates improved quality of life.

"The improved survival of end-stage colorectal cancer patients supports the growing body of evidence of the clinical benefits of DAVANAT®. This is the first time a polysaccharide used in colorectal cancer patients has demonstrated a dramatic improvement in safety and efficacy," said David Platt, PhD, chief executive officer, Pro-Pharmaceuticals, Inc.

The study objective was to treat end-stage colorectal cancer patients whose disease had progressed after receiving at least two lines of therapy that collectively included all of the following agents: 5-fluorouracil or capecitabine, irinotecan, and oxaliplatin. However, the final analysis revealed that the majority of patients also had been previously treated, and had disease progression, after therapy with AVASTIN® (bevacizumab) and/or ERBITUX® used in combination with chemotherapies.

Early data from the ongoing Phase II clinical trial for first-line treatment of colorectal cancer patients confirmed that 43 percent of evaluable patients have significant tumor shrinkage. In addition, none of the patients experienced hematological or gastrointestinal SAEs, grade 3 or higher. SAEs generally result in life threatening events, inpatient hospitalization, persistent or significant disability, or death. Some patients have completed more than one year of treatment.

"We are making excellent progress towards our goal of developing and commercializing our proprietary carbohydrate compounds," said Theodore Zucconi, PhD, president.

Source: Pro-Pharmaceuticals, Inc.

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