Access Pharma Initiates Oral Insulin Licensing Discussions

DALLAS, June 17 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News) announced today that the Company has signed evaluation agreements with two biopharmaceutical companies for its Cobalamin(TM) Oral Drug Delivery Technology. Under the terms of the agreements, both companies plan to evaluate Access' Oral Insulin product in preclinical models as a prerequisite to entering licensing discussions. Access announced previously that it had an agreement with a large pharmaceutical company for the evaluation of Cobalamin oral drug delivery formulations of human growth hormone (hGH).

"While all of the products and technologies which we chose to showcase at the recent BIO 2009 conference in Atlanta attracted a great deal of interest, it was clear that the Cobalamin oral drug delivery technology generated the most interest," commented Phillip Wise, Access' Vice President of Business Development and Strategy. "We are delighted that two companies have decided to take a closer look at the Cobalamin oral drug delivery technology. Meanwhile, we have several ongoing discussions with other companies regarding the application of our oral drug delivery options for their promising new drugs."

The proprietary Cobalamin(TM) technology utilizes the body's natural vitamin B12 oral uptake mechanism to facilitate oral absorption of pharmaceuticals by a "Trojan horse" mechanism. Since presenting promising results at a scientific conference in mid-2008, Access has made substantial improvements to the formulation technology. 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) equivalent to 90% 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' 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."

The ability of the Cobalamin technology to increase the efficacy of a cytotoxic drug through enhanced delivery to tumor cells was demonstrated in a preclinical model. This work was presented by Access at a major scientific meeting in 2008.

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