Access Pharma is currently developing cobalamin-based oral insulin to treat type 2 diabetes, the company announced.
Access’ patented Cobalamin technology utilizes the body’s natural vitamin B12 oral uptake to facilitate oral absorption of pharmaceuticals by a “Trojan horse” mechanism.
This technology platform provides Access with the ability to develop a number of different formulations with improved benefits for various disease applications.
In addition to insulin, Access has applied this technology to human growth hormone (HGH) and resulted in a formulation demonstrating efficacy that represents of over 25% improvement in weight gain, when given orally in an established animal model.
Access continues to move its insulin and HGH products towards clinical development, while submitting additional patents surrounding both formulations.
Access Pharma signed a collaborative development agreement with bioRASI, LLC, a full-service global CRO specializing in the accelerated development of novel therapeutics, to facilitate clinical development for its Cobalamin-based oral insulin and other Cobalamin-based products.
A major focus of this programme will be a first-in-man study for Access’ oral insulin product.
The collaboration agreement comes on the heels of the company’s recent announcement confirming significant oral bioavailability of the Cobalamin-based insulin, greater than 80 per cent of that achieved through insulin injection, in two different animal species models.
bioRASI will utilize its Translational Clinical Development Process which has demonstrated the ability to generate high quality human proof-of-principle data very quickly and cost-effectively, particularly in the Russian Federation.
Under the agreement, bioRASI will implement the development program necessary to initiate the first-in-man study in Russia and satisfy all regulatory requirements through approval.
Preclinical and clinical studies will be conducted at highly-respected research facilities within Russian Federation and will follow the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines to support regulatory submissions in Europe, Japan and the United States.
While facilitating the studies and satisfying all necessary regulatory requirements for the program, bioRASI will also assist Access in finding partners for oral insulin and other Cobalamin-based products in Russia and other Eastern European and CIS countries.
Access has the option to extend the agreement to additional Cobalamin-based products following a similar development pathway. At a future time the Parties may agree for bioRASI to take an equity position in Access for some or all of the expenses associated with this project.
“We believe our Cobalamin drug delivery technology has been an undervalued part of our portfolio and we look forward to demonstrating its true value,” stated Jeffrey Davis, Access Pharmaceuticals’ president and CEO.
bioRASI is a full-service global CRO specializing in the accelerated development of novel therapeutics through its close collaboration with the Russian Academy of Sciences and extensive experience with Russian and other Eastern European regulatory systems.
Several companies, including India’s Biocon, are currently in the process of making oral formulation of insulin.
Insulin pill, currently being developed by India’s biggest biotechnology company Biocon, plans to begin commercial production within 18 months, stated Biocon’s managing director Kiran Mazumdar- Shaw, in an interview given to a leading newswire.
Danish firm Novo Nordisk A/S has already begun first in man studies for its experimental insulin pill which pill replace the routine injection for diabetics even as India’s Biocon is completing its version of oral insulin for scheduled launch in next 18 months.
Access Pharmaceuticals is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients.
Access’ products include ProLindac, currently in Phase II clinical testing of patients with ovarian cancer, and MuGard for the management of patients with mucositis.
The company also has other advanced drug delivery technologies including Cobalamin-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.