Access Pharmaceuticals (OTC: ACCP) has completed enrolment and evaluation of the last additional cohort of patients from the ongoing clinical study of its therapy for ovarian cancer, ProLindac. The treatment had the same beneficial pharmacodynamic effect seen in the first 26 patients and none of the 8 patients experienced any acute significant adverse events. Access said the overall results of the Phase I/II exploratory single agent ProLindac study has helped define multiple safe dosing regimens.

Access believes that the results are very reassuring and it is pleased with the quality of its latest scalable process product, which is driving it towards an ambitious NDA (New Drug Application) strategy. The emerging bio-pharmaceutical company is initiating a study of ProLindac combined with Paclitaxel in second line treatment of platinum pre-treated advanced ovarian cancer patients, based on these results.

“The choice of Paclitaxel and ovarian cancer as the potential first NDA strategic choice to be explored is based on the excellent results of the Paclitaxel/Oxaliplatin combination in the same clinical setting”, Access vice chairman Prof Esteban Cvitkovic said, “The very ambitious primary efficacy endpoint goal is to achieve a minimum of 63% response rate in the total of 25 evaluable patients."

The new study will be the first to look at the safety and efficacy of ProLindac in combination with other oncology agents. Access said it is confident that ProLindac in combination with Paclitaxel will be well tolerated in the patient population and it anticipates significant activity, based on current experience with ProLindac in heavily pre-treated patients.

"This first combination study is a major milestone for ProLindac and Access Pharmaceuticals. We believe the data generated by the combination study will demonstrate that this combination can be an effective treatment option for patients with hard to treat late stage ovarian cancer", said Access president & CEO Jeffrey B. Davis.