On 8/3/09, Access Pharma (OTCQB:ACCP-OLD) provided 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. Access has commenced a new clinical study of ProLindac in France. The study will examine dose levels and regimens of ProLindac mono-therapy in cancer patients, provide additional data to support design of combination studies, and extend the safety database for the drug. Two ovarian cancer patients have been enrolled in the study to date, and the Company expects to enroll 6-12 patients this year before beginning to enroll patients in clinical trials evaluating ProLindac in combination with other chemotherapies (likely to involve ProLindac plus paclitaxel--Taxol and/or gemcitabine--Gemzar).
Access recently announced data from a recurrent ovarian cancer trial that showed that ProLindac was more active than currently available platinum drugs in that patient population, and that the drug was very well tolerated. ProLindac is a novel DACH platinum drug that has shown to be active in many solid tumors in human clinical studies. Platinum drugs are one of the most clinically and commercially successful class of chemotherapies and generated more than $3 billion in revenue globally in 2008. Access believes that ProLindac, as a well-tolerated and active DACH platinum, represents a important improvement in the design and tolerability of platinum chemotherapies.
Later this month, an Access management and clinical development team is meeting with Access' partner, Aosaikang Medicinal Group (Ask-Pharm) and several key oncology opinion leaders to finalize plans for ProLindac development in China. In addition, Access is meeting with its Korean partner, JCOM of Seoul, South Korea to finalize development plans in that territory. Access believes that three ProLindac combination trials will start shortly upon regulatory approvals of protocols in both China and Korea. Further, Access has reported receipt of additional milestone payments from its Far East partners in the ordinary course under their collaborative agreements.
"Our Chinese partner, Ask-Pharm, has made great progress on manufacturing scale-up of ProLindac and advancing the Regulatory process with the sFDA. We are excited about finalizing protocols with Ask-Pharm and leading oncologists in China, and look forward to their continued progress," stated Jeffrey B. Davis, Access' President and CEO. "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."
Access intends to design all clinical studies of ProLindac in accordance with FDA standards and intends to use the clinical data from all three planned clinical trials in the Far East to further development in North America and Europe. Access has the right to all clinical data generated in the Far East under the agreements entered into with their Far East partners, and as previously announced, believes that these trials run by its ProLindac partners will save Access between $20-30 million in clinical development expenses.
Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories. The Company has previously announced that it has licensed ProLindac to Ask-Pharm for the Greater China Region and to JCOM, Ltd for South Korea. Under these agreements both of these partners will be conducting Phase 2 combination studies with ProLindac in specific tumor types at their expense based on these results.
ProLindac is a very promising, next-generation 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 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 half (50-60%) of the platinum is released over a period of 96 hours (four days) from a single administration. Thus, 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 posted estimated global sales of $2.5 billion in 2008 for Sanofi-Aventis (NYSE:SNY). In addition to having more side effects than ProLindac, Eloxatin is available on an off-patent basis in Europe. Access also employs Esteban Cvitkovic as their director of oncology R&D - who has over 30 years of experience in this area and played a key role at SNY in the development and approval of Eloxatin. Preliminary data from a Phase 2 clinical trial in patients with relapsed ovarian cancer demonstrated that over 12X the dose of ProLindac was delivered compared to Eloxatin and the final data from this trial is still pending.
Despite the much larger platinum dose delivered by ProLindac, the drug demonstrated an excellent safety profile in the trial among patients receiving nine or more cycles of therapy. 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. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.
Disclosure: Long ACCP.OB