Written by Grant Zeng, CFA
On Nov. 3, 2010, Access Pharmaceuticals Inc. (ACCP) announced that it has commenced a second line Phase II combination trial for its second generation DACH-platinum cancer drug, ProLindac, in platinum-sensitive ovarian-cancer patients.
As a reminder, ProLindac is a novel DACH platinum prodrug. It is a polymer therapeutic that utilizes a safe, water-soluble nanoparticulate system to deliver DACH platinum to tumors, while reducing delivery to normal tissue, resulting in increase in drug effectiveness and a significant decrease in toxic side-effects seen in the currently marketed DACH platinum, Eloxatin (Sanofi-Aventis), which has sales in excess of $2 billion.
This trial is an open-label, Phase II study of ProLindac given intravenously with paclitaxel. The combination trial will be conducted in up to eight European participating centers. This new Phase II trial for ProLindac is based on the positive safety and efficacy results from its Phase II monotherapy clinical study of ProLindac in late-stage, heavily pretreated ovarian cancer patients. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria, including sustained significant reductions in Ca-125, the established specific serum marker for ovarian cancer, observed in several patients. No patient in any dose group exhibited signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin. ProLindac was very well tolerated, with only minor sporadic hematologic toxicity.
We are pleased to see that Access is making progress to advance its pipeline. This Phase II study of ProLindac will be the first of several ProLindac-based combination studies in a variety of indications. The company is evaluating various indications where DACH Platinum-based combinations have proven already active, such as hepatocarcinoma, biliary tree cancer and pancreatic cancer before deciding on an expanded Phase II program.
With MuGard already in the market combined with the deep pipeline, we believe Access is heading in the right direction for growth.
ACCESS PHARMA (ACCP): Free Stock Analysis Report
Zacks Investment Research
