Access Pharma Launches Clinical Development Program for Oral Insulin Product

DALLAS, March 30 /PRNewswire-FirstCall/ -- 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."

About Cobalamin

Access' worldwide-exclusive patented Cobalamin™ technology utilizes the body's natural vitamin B12 oral uptake to facilitate oral absorption of pharmaceuticals by a "Trojan horse" mechanism. This technology platform provides Access with the ability to develop a number of different formulations with improved benefits for various disease applications.  In addition to insulin, Access has applied this technology to human growth hormone (HGH) and resulted in a formulation demonstrating efficacy that represents of over 25% improvement in weight gain, when given orally in an established animal model.  Access continues to move its insulin and HGH products towards clinical development, while submitting additional patents surrounding both formulations.

About bioRASI

bioRASI, LLC is a Full Service Global CRO that collaborates with the leading biotech and pharmaceutical companies in the clinical development of novel and generic therapeutics. Specializing in ANDA and 505(b)(2) NDA programs, bioRASI facilitates obtaining FDA approvals by delivering high quality regulatory and clinical strategies, solutions and services, while saving their clients critical time. bioRASI services include the full spectrum of program management, regulatory, clinical, data management and analysis, and compliance and audit. bioRASI leverages its access to well renowned researchers and facilities, in the U.S., Europe and Asia, to achieve unparalleled scientific, clinical and business results at significantly lower costs. Further information about bioRASI is available at http://www.biorasi.com/.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include ProLindac™, currently in Phase II clinical testing of patients with ovarian cancer, and MuGard™ for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin™-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit our website at http://www.accesspharma.com/.

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 cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our 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 Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

SOURCE Access Pharmaceuticals, Inc.