Pro-Pharmaceuticals' preliminary phase 2 data show partial tumor response with Davanat plus 5-FU

By Lisa Kerner

Erie, Pa., April 5 - Pro-Pharmaceuticals, Inc. said preliminary data show an objective partial tumor response - at least a 50% reduction in tumor size per Response Evaluation Criteria in Solid Tumors (Recist) guidelines - in stage 1of its phase 2 trial for third- and fourth-line treatment of colorectal cancer.

The phase 2 study is designed to evaluate the safety and efficacy of Davanat plus 5-fluorouracil (5-FU) to shrink tumors or prevent further growth, according to a company news release. Patients, who have a minimum of five weeks to live, are receiving Davanat plus 5-FU in monthly cycles for at least two cycles or until their disease progresses.

The company said it will not enroll patients in stage 2 of the trial but will begin dosing patients in a Europe-based multicenter randomized phase 3 clinical trial for the second-line treatment of colorectal cancer patients by the end of the second quarter.

This trial will evaluate the safety and efficacy of Davanat with 5-FU and leucovorin in combination with irinotecan or oxaliplatin for second-line treatment of metastatic colorectal cancer patients, with a primary endpoint of progression-free survival.

Pro-Pharmaceuticals also began a phase 2 study of Davanat with 5-FU for first-line treatment of patients with cholangiocarcinoma (cancer of the bile duct), with enrollment to begin in the second quarter.

Davanat is a proprietary polysaccharide polymer that enables the targeted delivery of chemotherapy drugs to protein receptors (lectins) on cancer cells.

Located in Newton, Mass., Pro-Pharmaceuticals discovers, develops and commercializes carbohydrate-based therapeutic compounds for the treatment of cancer, viral infections and other diseases.

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