Access Pharmaceuticals, a biopharmaceutical company, has announced positive safety and efficacy results from its Phase II monotherapy clinical study of ProLindac in late-stage, heavily pretreated ovarian cancer patients.
In this monotherapy study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to response evaluation criteria in solid tumors (RECIST) criteria. Sustained and significant reductions in Ca-125, the established specific serum marker for ovarian cancer, were also observed in several patients, the company said.
According to Access Pharmaceuticals, no patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall. The maximum tolerated dose of ProLindac was established as well as the recommended dose levels for future combination studies.
This 26 patient Phase II study explored three different dose levels and two dosing regimens of ProLindac as a monotherapy treatment for advanced ovarian cancer, to provide data on the monotherapy anticanceractivity and safety of ProLindac.
Access has previously licensed ProLindac to Jiangsu Aosaikang Pharmaceutical Co for the Greater China region and to Jcom for South Korea. Under these agreements both of these partners will be conducting Phase II combination studies with ProLindac in specific tumor types at their expense based on these results. Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories.
Jeffrey Davis, president and CEO of Access, said: These data provide us with a strong incentive to continue the clinical development of ProLindac. As previously announced, we are currently planning a number of combination trials, looking at combining ProLindac with other cancer agents, such as taxol and gemcitabine, in multiple solid tumor indications including colorectal and ovarian.