Preclinical study results of Cobalamin expected by March 31, 2010 (OTCBB:ACCP)

Cobalamin™ is a drug delivery system that has been developed and manufactured by Access Pharmaceuticals, Inc. (OTCBB:ACCP). The company has been planning to bring the drug into the markets of the United States of America. For this reason, it needs the approval from the country’s toughest regulator – that is, the Food and Drug Administration (FDA). However, in order to get the FDA’s approval, it must convince the regulator that its drug delivery system is both safe and effective. The company has already started conducting preclinical studies on its product soon. The study results will be available by March 31, 2010.

The Cobalamin drug delivery technology makes use of the natural body mechanism through which vitamin B12 taken orally can be absorbed. The product is based on the innovative idea that the same body mechanism can help the absorption of oral drugs. In fact, the drug absorption can become a lot faster – a phenomenon called “Trojan horse”. This drug delivery technology is used for the following types of drugs: insulin, hormone causing growth in humans, and two types of peptides which cannot be taken orally and thus must be injected into the body.

While discussing the current and potential applications of the drug delivery technology, David P. Nowotnik, Ph.D., who is the Senior Vice President of the Research & Development department of Access Pharmaceuticals, said:

“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. 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.”