Pro-Pharmaceuticals has announced that preliminary data shows an objective partial tumor response from a patient in Stage 1 of a Simon's 2-stage designed Phase II trial for third- and fourth-line treatment of colorectal cancer.
In the Phase II colorectal cancer trial, patients with colon cancer, which has spread despite treatment with approved therapies, are receiving Davanat plus 5-fluorouracil (5-FU) in monthly cycles for at least two cycles or until their disease progresses. The study is designed to evaluate the safety and efficacy of Davanat plus 5-FU to shrink tumors or prevent further growth. These patients are refractory to 5-FU and have a minimum of 12 weeks to live. Dosing of patients began in May 2005.