Access Pharmaceuticals, Inc. announced this morning that it has completed enrollment and evaluation of the last additional group of patients in the ongoing clinical study of ProLindac as a monotherapy in ovarian cancer patients who have received at least two prior platinum based treatment regimens. The additional group of 8 patients received the ProLindac batch made by an improved scalable process, which will be used on a larger scale for future clinical and commercial supplies.
According to the press release, none of the patients experienced any acute significant adverse events. In addition, treatment had the same beneficial pharmacodynamic effect seen in the first 26 patients treated with the former ProLindac production batch. Clinically relevant sustained biomarker decrease (responses by Rustin’s criteria) and disease stabilization were seen in several patients. The overall results of Access’ Phase I/II exploratory single agent ProLindac study have helped define multiple safe dosing regimens, while the level of patient cohort accrued in the study antitumor activity was as expected in this very heavily pretreated patient group.
Based on these results, the company will initiate a study of ProLindac combined with Paclitaxel in second line treatment of platinum pretreated advanced ovarian cancer patients. This will be the first study to look at the safety and efficacy of ProLindac in combination with other oncology agents.
Prof. Esteban Cvitkovic, Vice Chairman of Access and a clinical oncologist overseeing the combination study in Europe, stated, “The efficacy of Diamino Cyclohexane Platinum, the active principle in ProLindac, is evidenced mainly through their synergic association with multiple anticancer agents. 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. This multi-center study of up to 25 evaluable patients will be conducted in Europe.”
“The very ambitious primary efficacy endpoint goal is to achieve a minimum of 63% response rate in the total of 25 evaluable patients the study is planning to accrue on a two step design,” he continued. “We are very reassured and pleased with these results and the quality of the latest scalable process product, which is driving us towards an ambitious NDA strategy with an exploratory trial based upon the well known synergistic power of DACH platinums with a variety of anticancer agents. We are confident that ProLindac in combination with Paclitaxel will be well tolerated in this patient population and anticipate significant activity based on our current experience with ProLindac in heavily pretreated 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,” commented Jeffrey B. Davis, President & CEO of Access. “Our efforts, combined with the efforts of our Asian partners, are targeted at demonstrating the safety and efficacy of ProLindac in multiple combination treatment protocols for a range of cancer types. We believe ProLindac is new DACH platinum chemotherapy in continued clinical development at this stage.”
Access’ Asian partners continue to prepare regulatory and other filings in South Korea and China to commence other combination clinical studies with ProLindac. It is anticipated that these studies will provide clinical data for additional indications for ProLindac beyond late stage ovarian cancer. Additional indications under consideration include hepatocellular carcinoma, pancreatic, endometrial and others.