Access Pharma (OTC: ACCP.OB) announced today that it completed evaluation of the last additional cohort of eight patients for its ongoing study of ProLindac as mono-therapy for ovarian cancer patients who were previously treated with at least two platinum-based anti-cancer regimens. The eight-patient cohort received ProLindac that was manufactured by a new, improved process that is scalable and will be used for future studies and commercialization. This small, pilot study validates the new, scalable manufacturing process for ProLindac that is a key component for partnership discussions and large-scale production of the drug for late-stage / pivotal studies and potential commercialization.
Results in these eight patients demonstrated an equivalent safety (no significant adverse events were reported) and pharmacological profile for the new manufacturing process as compared to the first 26 patients in the study who received ProLindac from the former process. The Phase I/II exploratory study for ProLindac as a single agent also demonstrated disease stabilization in several patients, a sustained decrease in relevant cancer biomarkers, and established multiple safe dosing regimens for future trials.
ProLindac is a next-generation DACH platinum anti-cancer compound which includes a proprietary nano-polymer drug delivery vehicle that allows for over 10X the dose of platinum to be delivered in a targeted manner to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity. The unique nano-polymer delivery system selectively releases the DACH platinum in a targeted manner to cancer cells because they reside at a low pH (acidic).
Pharmacology studies conducted outside of living, human tissue (ex-vivo) within comparable environments (e.g. acidic or low pH) to the tumors being treated by ProLindac have demonstrated that about 50-60% of the platinum is released over a period of 96 hours (four days) from a single administration so that a single dose of ProLindac not only delivers over 10X the platinum dose in a targeted manner to cancer cells, but also mimics a four-day continuous infusion as the drug persists at the tumor site.
ProLindac is meant to be a safer, more effective replacement for Eloxatin (oxaliplatin), which is an estimated $2 billion drug for Sanofi-Aventis (NYSE: SNY). Access previously announced positive safety and efficacy results from its Phase 2 mono-therapy clinical study of ProLindac in late-stage, heavily pretreated patients with ovarian cancer. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria while no patient in any dose group exhibited signs of acute neurotoxicity (which is a major side-effect of the approved DACH platinum, Eloxatin).
Access also employs Esteban Cvitkovic as Vice Chairman / Senior Director of Clinical Oncology, who has over 30 years of experience in oncology and played a key role at SNY in the development and regulatory approval process for Eloxatin, who believes ProLindac is positioned as the lead, next-generation platinum drug in development following two recent platinum drugs in development which failed to reach their primary endpoints in pivotal Phase 3 studies.
In mid-November 2009, Poniard Pharma (NASDAQ: PARD) announced that its experimental anti-cancer platinum drug picoplatin did not reach its primary endpoint of overall survival in a pivotal Phase 3 study as second-line treatment for patients with small cell lung cancer. In addition, another platinum drug in development by GPC Biotech (GPC.DE) and Spectrum Pharma (NASDAQ: SPPI), satraplatin, failed to achieve its primary endpoint in a pivotal Phase 3 trial for patients with hormone-refractory prostate cancer whose disease has progressed after initial chemotherapy treatment and is currently in Phase 2 trials for patients with non-small cell lung cancer.
Access also announced today that it will conduct a combination study evaluating ProLindac plus Taxol (paclitaxel) for second-line treatment of platinum pre-treated patients with advanced ovarian cancer. This is a multi-center study being conducted in Europe in up to 25 evaluable patients with primary efficacy endpoint goal of achieving at least a 63% response rate. Access has chosen the combination with paclitaxel in late-stage ovarian cancer (first relapse) patients as the initial potential NDA filing target based on previously demonstrated synergistic effects of ProLindac and other anti-cancer agents, the experience of ProLindac in platinum pre-treated patients, and excellent results of paclitaxel plus Eloxatin combination therapy in the same patient population.
The Company expects to begin patient dosing in the Phase 2 combination trial by March-April and the initial cohort of about 10 patients will begin the study as an open-label, dose-escalation study that is expected to provide initial results during 3Q09. Based on initial results, the study could be expanded and rolled into a pivotal Phase 3 multi-center, randomized / controlled trial (with an estimated 60-80 patients per treatment arm) or a potential partner could step in and assume control of clinical development for such a trial during 2H10.
The Company’s corporate partners (Ask-Pharm in China and JCOM in South Korea) in Asia continue to prepare for additional combination clinical studies with ProLindac plus Gemzar (gemcitabine) to provide clinical data for additional indications of ProLindac beyond late-stage ovarian cancer, such as hepatocellular carcinoma (primary liver cancer) and pancreatic cancer, based upon the promising results of gemcitabine plus Eloxatin in these patient populations.
These will be larger, randomized / controlled trials with expected enrollment of approximately 80 patients per treatment arm, pending regulatory approval to begin such studies that is expected during 1H10. As previously announced, Access estimates these studies will save about $20-30 million in clinical development expenses while providing clinical data that can be used by the Company in accordance with FDA standards.