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Data demonstrates that new Cobalamin oral insulin and oral human growth hormone formulations provide significant pharmacological responses in preclinical models
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) provided an update today on its Cobalamin(TM) oral drug delivery product development programs. 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. 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. Since presenting promising results at a major 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.
Cobalamin is Access' proprietary technology based upon the use of vitamin B12 for targeted delivery of drugs to disease sites and for oral drug delivery of drugs that otherwise have poor oral bioavailability. The Access development of a Cobalamin human growth hormone formulation is sponsored with funding from a major pharmaceutical company, and Access is in discussion with other companies regarding the application of the Cobalamin technology to other actives.
"The recent improvements we have made to the nanoparticle carrier systems should provide us with the ability to adapt the technology more readily to other actives, allowing us to move new formulations more rapidly to the clinic," commented David P Nowotnik, Ph.D, Access' Senior Vice President of R&D. "There are numerous actives that cannot be delivered orally, and so it is not surprising that large pharma is showing a lot of interest in the Cobalamin technology."
About Access Pharmaceuticals, Inc.
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac(TM), currently in Phase 2 clinical testing of patients with ovarian cancer, and MuGard(TM) for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin(TM)-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix(R), a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; Prodrax(R), a non-toxic prodrug which is activated in the hypoxic zones of solid tumors to kill cancer cells; Alchemix, a chemotherapeutic agent that combines multiple modes of action to overcome drug resistance. Access is also developing Phenylbutyrate ("PB"), an HDAC inhibitor and differentiating agent currently a Phase 2 clinical candidate.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our ability to close the financing transaction, early results from our clinical trial, Access' plans to continue and initiate clinical trials, the value of its products in the market, its ability to achieve clinical and commercial success and its ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Report on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
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