ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) 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 program will be a first-in-man study for Access' oral insulin product. The study is an important step in obtaining human confirmation of the significant oral bioavailability present in Access' Cobalamin oral insulin formulations. 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% 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 are excited about this collaboration with bioRASI and the strategy we set forth in this agreement," said Jeffrey Davis, Access Pharmaceuticals' President and CEO. He continued, "Capitalizing on bioRASI's distinct expertise in developing drugs for diabetes and in obtaining necessary regulatory approvals provides Access with a solid foundation for accelerated and cost-effective development of our Cobalamin oral insulin product and future Cobalamin-based products. We believe our Cobalamin drug delivery technology has been an undervalued part of our portfolio and we look forward to demonstrating its true value."
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. In addition, through its partnership with The Diabetes Research Institute at the University of Miami Miller School of Medicine, bioRASI has considerable expertise in the areas of development of drugs for the treatment of diabetes. bioRASI is primarily focused on the development and approval of pharmaceutical products under 505(b)(2) and 505(j) NDA regulatory pathways. The Cobalamin-based oral insulin product approval path is expected to be a 505(b)(2) process.
Boris Reznik, PhD, President and CEO of bioRASI commented, "This program is a great fit for the capabilities of both bioRASI and our established partners. Given the well understood clinical utility of insulin, establishing the human oral bioavailability of Access' product could be a huge step forward for both the oral insulin product and the broader Cobalamin formulation technology platform. Following initial success in the oral insulin program, we look forward to expanding this collaboration to several other promising Cobalamin-based products."
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