Access Pharmaceuticals, Inc, a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, has commenced a phase-2 combination trial for its second generation DACH-platinum cancer drug, ProLindac, in platinum-sensitive ovarian-cancer patients. This trial is an open-label, phase-2 study of ProLindac given intravenously with paclitaxel. The combination trial will be conducted in up to eight European participating centers.
“We are very pleased to be able to begin this trial, which will be the first of several ProLindac-based combination studies in a variety of indications,” said professor Esteban Cvitkovic, vice chairman Europe and senior director Clinical Oncology R&D, Access Pharmaceuticals, Inc. He continued, “The ambitious two-step design of the study will allow us to rapidly benchmark ProLindac/paclitaxel in a clinical setting where there is a clear need to establish an improved standard for long-term tumour responses. When treated using the current first-line combination of carboplatin/paclitaxel, more than half of patients with advanced ovarian cancer will relapse. There are very few second-line options. Approved agents for second-line and later therapy are currently focused primarily on the palliation of more resistant tumours. This lack of valid second-line options presents an opportunity to prove the role of ProLindac-based combinations in ovarian cancer.”
“After optimizing ProLindac’s scaled-up manufacturing process, we are pleased to be moving forward with its clinical development,” said Jeff Davis, president and CEO, Access Pharmaceuticals, Inc. He continued, “We think there is a significant clinical need and commercial opportunity for safer, more effective platinum drugs.”
Access previously announced positive safety and efficacy results from its phase-2 monotherapy clinical study of ProLindac in late-stage, heavily pretreated ovarian cancer patients. In this study, 66 per cent 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.
Access 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-2 programme.
ProLindac is a novel DACH platinum prodrug that has completed a phase-2 monotherapy study in ovarian cancer patients. It is a polymer therapeutic that utilizes a safe, water-soluble nanoparticulate system to deliver DACH platinum to tumours, while reducing delivery to normal tissue, resulting in increases 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 US$ 2 billion.
Access Pharmaceuticals is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients.