Pro-Pharmaceuticals begins phase II cancer trial

The study is in metastatic colorectal cancer patients who have disease progression after receiving standard chemotherapeutic regimens and is the result of a collaboration between Pro-Pharmaceuticals and the Hematology-Oncology Associates of Treasure Coast in Florida.

The phase II, multi-center, open-label trial will evaluate the efficacy and safety of intravenous Davanat-R-/5-FU, a carbohydrate, in combination with 5-fluorouracil (5-FU) when administered in monthly cycles as third- or fourth-line therapy for metastatic colorectal cancer. Seven medical centers will take part in this trial, which expects to enroll up to 38 patients and uses Simon’s 2-stage design.

Commenting on the research collaboration, Dr Eliezer Zomer, executive vice president of product development at Pro-Pharmaceuticals, said working with the Hematology-Oncology Associates “enables us to accelerate our progress in advancing our lead anti-cancer compound Davanat through the clinical assessment program and marks another successful milestone in our company’s development objectives.”

Davanat has been shown to increase the anti-tumor activity of 5-FU, a commonly used cancer treatment, in mice. A phase I clinical study also showed Davanat combined with 5-FU to be well tolerated in treatment-resistant patients with solid tumors.