By Mike Havrilla, ProActive News Room
Access Pharma (OTC: ACCP.OB) provided an update today on the status of its cobalamin-based oral drug delivery product development programs. The BioMedReports.com research downloads section and the ProActive News Room website for Access both contain the most recent research reports and presentation for the Company, following its presentation last week at the OneMed Forum in San Francisco, which was held in conjunction with the JP Morgan Healthcare Conference.
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). The oral insulin and hGH formulations represent the most developed product candidates in terms of preclinical studies and formulation, in preparation for potential licensing deals and / or proof-of-concept clinical trials in humans.
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-pharma 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% bioavailability achieved by Access in preclinical studies for its oral insulin formulation.
Final results from the non-exclusive collaborators are possible during 1Q10 while Access may initiate proof-of-concept (Phase 1 equivalent) studies for oral insulin in humans in Eastern Europe or India during 2H10 (with expected duration of 3-5 months and cost of $250-300,000), and also plans to file an additional patent application reflecting improvements to the technology.
While most investors are focused on the oncology products (MuGard) and pipeline (ProLindac, Thiarabine, Angiolix) for Access Pharma; the oral cobalamin drug delivery technology platform represents an undervalued and under-the-radar asset that is poised to gain more attention (and value) as the year progresses from additional preclinical / validation results for oral insulin, pending proof-of-concept studies in humans, potential licensing agreements, and the possibility for developing new compounds / therapeutic classes (e.g. RNA-based therapeutics) using this technology.
Disclosure: Long ACCP.OB
Related video: OneMedPlace interviews Access Pharmaceuticals CEO Jeffrey Davis.