This is a good article. Mike H must have talked to Access. It adds to today's PR. First, that ProLindac is positioned in the lead to be the next platinum compound. Second, they are planning to start it soon and expect initial results 3Q, then roll it into a Phase 3. This effectively would be a Phase 2/3 pivotal trial. Note that the end point is 63% for second-line. That is what they achieved with monotherapy on multiple-treated patients, so the endpoint looks very achievable. Davis has said in the past he believed he would wait till phase 2 interims to get a partner and the article repeats that. Therefore we could get a ProLindac partner in the 3Q. Sanofi? BMY?
They are going to need financing to pay for this. We should hear something soon on that.
Excerpt from the article: 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.