Access Releases Update On ProLindac Clinical Development Program

Access has released an update on its clinical development strategy for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumors in human clinical studies. The company has initiated a new clinical study of ProLindac in France.

The study will examine dose levels and regimens of ProLindac monotherapy in cancer patients, provide additional data to support design of combinations studies, and extend the safety database.

Reportedly, two ovarian cancer patients have been enrolled in the study so far. It is anticipated that six to 12 patients will be enrolled this year in advance of enrolling patients in trial, evaluating ProLindac in combination with other chemotherapies.

The company has recenty released data from a recurrent ovarian cancer trial that showed ProLindac to be more active than currently available platinum drugs in that patient population, and that the drug was very well tolerated. Access would start three ProLindac combination trials upon regulatory approvals of protocols in both China and Korea.

The company plans to design all clinical studies of ProLindac in accordance with FDA standards. It intends to use the clinical data from all three planned clinical trials in the Far East to further development in North America and Europe.

Jeffrey Davis, president and CEO of Access, said: “Our Chinese partner, ASK, has made great progress on manufacturing scale-up of ProLindac and advancing the Regulatory process with the FDA. We are excited about finalizing protocols with ASK and the leading oncologists in China, and look forward to their continued progress.

“Additionally, we are meeting this month with JCOM and key opinion leaders in Korea, and hope to get the combination trials started in Korea as soon as reasonably possible,” he added.