21:20 17.06.2009 | All news from "Cancer"
Access Pharmaceuticals Provides Update On Prolindac Phase 2 Ovarian Cancer Trial And Clinical Development Plan
June 11, 2009
Access Pharmaceuticals, Inc., provided an update today on the progress in the Company's clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. Access recently announced positive safety and efficacy results from its Phase 2 monotherapy clinical study of ProLindac(TM) 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. 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 Company has scaled up manufacturing in order to begin the next phase of clinical development. Access plans to conduct several combination trials in different solid tumor types both as Company-sponsored trials and in conjunction with its two previously announced co-development partners.
"Access is extremely pleased with the clinical results to date, which we believe reflect that we have a significant DACH platinum drug candidate with a safety profile superior to commercially available platinum therapies," stated Jeffrey Davis, President & CEO. "Our partners in the Far East, both Aosaikang Medicinal Group (ASK) in Nanjing, China and JCOM, in Seoul, Korea, are making great progress on manufacturing scale-up and in putting the regulatory process in place, and we are working with them diligently on the design and future management of their clinical trials. Access is in discussion with a number of potential North American and European partners for co-development of ProLindac, and to assist in marketing, when approved."
"We are very pleased with the ProLindac trial results to date which has been in over 50 patients in two trials; we saw significant DACH platinum activity and efficacy in patients at the highest dose levels which is very encouraging given that this study involved monotherapy in a heavily pretreated patient population that typically only respond to an aggressive drug combination," commented Dr. David Nowotnik, Access' Senior Vice President R & D.
The recent Phase 2 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 anticancer activity and safety of ProLindac. Of patients eligible for evaluation according to standard RECIST criteria, clinically-meaningful disease stabilization was achieved in 42% of all patients, and 66% of all patients in the higher dose groups. Sustained and significant reductions in Ca-125, the established specific serum marker for ovarian cancer, were also observed in several patients.
Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories.
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