Update on Prolindac clinical development plan provided by Access Pharmaceuticals

Sep 11 2009

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), provided an update today on 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' clinical development team recently met with its partners Aosaikang Medicinal Group (ASK) in Nanjing, China and JCOM, Ltd. ("JCOM") in Seoul, Korea, together with key opinion leaders in oncology indications to discuss the protocols for the three planned ProLindac combination studies. Access and its partners are finalizing development plans and protocols for clinical trials strategically designed to examine ProLindac in combination with gemcitabine and/or taxol in hepatocellular carcinoma (a form of liver cancer), pancreatic cancer and recurrent ovarian cancer.

Access previously 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 recent Phase 2 recurrent ovarian 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 extremely pleased with the clinical progress to date, and look forward to initiation of clinical trials looking at ProLindac in combination with commonly used chemotherapies," stated Jeffrey Davis, President & CEO. "Our partners in the Far East hosted Access together with key opinion leaders in oncology indications to discuss various potential protocol options, and hope to start enrolling patients in up to three combination trials by the end of the year, depending upon regulatory approvals of the trial protocols and certain other matters."

Source: http://www.accesspharma.com