Access is currently working with leukemia and lymphoma specialists to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and B-Cell lymphomas. These pilot studies are expected to begin during 2Q10 and will seek to determine the optimal dosage regimen and most susceptible malignancies for future trials to serve as the basis for partnership discussions for further development and commercialization.
In early January, Access announced successful results in a small, pilot study that 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. 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.
Access will also 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 and expects to begin patient dosing by March-April 2010. 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 and a possible partnership or larger pivotal Phase 3 trial could begin during 2H10.
Access has developed a nano-polymer drug delivery system for the oral administration of large molecules that are currently administered as injections (e.g. insulin, human growth hormone/hGH, erythropoietin/EPO, fertility drugs, parathyroid hormone/PTH, RNA-based therapeutics, monoclonal antibodies). This drug delivery technology involves coating a nano-particle with a vitamin B-12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package, resulting in exponential increases in absorption through the gut of large molecule drugs / hormones typically administered by injection.
In June 2009, Access announced that two bio-pharmaceutical companies (one North American, one European) would conduct preclinical, proof-of-concept studies in animals (rat and dog models of diabetes) before proceeding to more formal negotiations for the Company's oral, long-acting (basal) insulin product candidate, seeking to validate the greater than 80% oral insulin bioavailability results achieved by Access in preclinical studies for its oral insulin formulation.