Access Pharmaceuticals provides update on its Cobalamin insulin development program

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) provided an update today on its Cobalamin™ oral drug delivery product development programs. The proprietary Cobalamin™ technology utilizes the body's natural vitamin B12 oral uptake mechanism to facilitate oral absorption of pharmaceuticals by a "Trojan horse" mechanism. Access has focused its Cobalamin product development program on the oral delivery of insulin and human growth hormone, two peptides which currently can only be given by injection. A new Cobalamin-coated insulin-containing nanoparticle formulation delivered orally provided a pharmacological response (lowering of blood glucose levels in an animal model of diabetes) greater than 80% of that achieved by insulin delivered subcutaneously. This represents a substantial oral bioavailability, indicating that this formulation has potential for clinical development and ultimate commercialization. Adaptation of this technology has provided a Cobalamin human growth hormone formulation that has demonstrated good efficacy, represented by more than 25% improvement in weight gain, when given orally in an established animal model. Access continues to move both products towards clinical development, and plans to submit an additional patent application to protect the improvements to the technology.

"While Access continues to explore potential collaborations on multiple applications of our technology, our Cobalamin oral insulin product continues to be the focus of current collaborative work," said Phillip Wise, Access' Vice President of Business Development and Strategy. "We continue to work with two companies testing Cobalamin oral insulin in multiple animal models. Meanwhile, we are pursuing options with other companies with the goal of initiating a proof-of-concept in man study."

Cobalamin is Access' proprietary technology based upon the use of vitamin B12 for oral drug delivery of drugs that otherwise have poor oral bioavailability. It also has potential for targeted delivery of drugs to disease sites. Access is developing its Cobalamin technology under multiple collaborative agreements, and is in discussion with other companies regarding the application of the Cobalamin technology to other active drug candidates.

"While Access' focus has been on the oral delivery of peptides, the technology is sufficiently flexible to allow us to deliver a wide range of actives," commented David P. Nowotnik, Ph.D, Access' Senior Vice President of R&D. "In addition to peptide delivery, we have received inquiries recently about the potential of this technology to deliver actives ranging from small molecules to siRNA to monoclonal antibodies. As siRNA needs to be delivered intracellularly to be effective as a therapeutic, the Cobalamin technology may be particularly beneficial as an intracellular delivery technology, as the demand for vitamin B12 increases in many disease states."

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