Access Pharmaceuticals Cobraxane Program Displays Significant Advantage Over Commercially-Available Paclitaxel Protein-Bound Particles

Comparative Studies From Company’s CobaCyte Tumor-Targeting Technology Program, Cobraxane, Demonstrate Superior Tumor Growth Inhibition

Dallas, TX and New York, NY, May 10, 2011

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced that it has made significant progress with its CobaCyteTM tumor-targeting technology.  Using a new proprietary CobaCyte paclitaxel nanoparticle formulation, named CobraxaneTM, the company’s scientists have observed significant tumor growth inhibition in preclinical tumor models.

In a murine solid tumor models, single doses of Cobraxane were compared with single doses of commercially-available paclitaxel protein-bound particles (Abraxane®).  At a dose of Cobraxane which was half that of the maximum tolerated dose (MTD) of the standard paclitaxel particles, Cobraxane demonstrated slightly better tumor growth inhibition than the MTD dose of standard paclitaxel particles. Cobraxane, injected at the same dose as the MTD dose of standard paclitaxel particles, provided significantly better tumor growth inhibition than the MTD dose of standard paclitaxel particles.  In fact, at the higher dose of Cobraxane, tumor shrinkage was observed.

“We know that in certain diseases, notably cancer, the affected cells can have an elevated demand for certain vitamins, including vitamin B12, and this principle serves as the scientific basis of our CobaCyte tumor-targeting technology,” said David Nowotnik, Senior Vice President Research and Development, Access Pharmaceuticals, Inc.  He continued, “The preclinical work done by the Access scientific team is key in evaluating and defining the potential efficacy and specificity of Cobraxane in   a variety of different tumors and we are pleased with our early findings.”

Jeffrey Davis, CEO of Access Pharmaceuticals stated, “The data observed in our Cobraxane models serves as a strong indicator of the potential clinical and commercial value Cobraxane offers.  Given the recent activity in the market surrounding the therapeutic impact associated with paclitaxel protein-bound chemotherapy, we are excited about the comparative data seen in our preclinical models and look forward to furthering the development of the Cobraxane program.”

Abraxane is a registered trademark of Celgene Corporation.

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 MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation DACH Platinum in Phase 2 clinical testing of patients with ovarian cancer, and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas.  

The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  For additional information on Access Pharmaceuticals, please visit our website at 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 to 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.

Access Pharmaceuticals Signs Agreement With Major Global Pharmaceutical Company for CobaCyte® and CobOral® RNAi Therapeutic Delivery Technologies

Dallas and New York, April 13, 2011

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has entered into an agreement with a major pharmaceutical company to exploit its CobaCyte and CobOral technology for the targeted delivery of RNAi therapeutics.  Access will provide the pharmaceutical company with CobOral and CobaCyte siRNA formulations for evaluation of gene knockdown following oral and intravenous administration.  Though the terms of the agreement have not been disclosed, Access indicated that any successful formulation developed will be jointly owned by the Parties and subject to a subsequent full licensing agreement.

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Access Pharmaceuticals ProLindac™ and CobaCyte™ Oncology Research Displayed at the Innovations in Cancer Prevention and Research Conference, November 17-19, 2010

Conference Hosted by the Cancer Prevention and Research Institute of Texas (CPRIT)

Dallas, TX and New York, NY, November 17, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced that two oncology posters are being displayed this week at the Innovations in Cancer Prevention and Research Conference at the Austin Convention Center in Austin, TX.  The poster being displayed, entitled “Vitamin B-12 Nanoparticles for the Targeted Delivery of RNAi Therapeutics”, summarizes key findings of the Company’s rebranded Cobalamin program, CobaCyte for RNAi.  The second poster, entitled “Preclinical and Clinical Studies of ProLindac: A Novel Polymer Prodrug of DACH Platinum”, details the distinct attributes and advantages of utilizing Access’ second generation DACH Platinum, ProLindac.
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Access Pharmaceuticals Awarded $1.5 Million in Section 48D Grants

Grants Cover ProLindac, Thiarabine, MuGard, CobOral Oral Insulin and CobaCyte siRNA Delivery Programs

Dallas, TX and New York, NY, November 1, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has been awarded $1.5 million in government grants. Under the recently enacted Patient Protection and Affordable Care Act, cash grants were awarded to Qualifying Therapeutic Discovery Projects that showed significant potential in producing new and cost-saving therapies, support job growth and increase U.S. competitiveness. Grants were awarded through a competitive application process, and seven out of eight Access Pharmaceutical applications were awarded.
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Access Pharmaceuticals Signs Agreement With Leading Biopharmaceutical Company to Develop CobOral™ Formulation of Widely-Marketed Injectable

Dallas, TX and New York, NY, October 27, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has entered into a pre-licensing feasibility agreement with a leading biopharmaceutical company to develop an oral formulation of an undisclosed prostate cancer compound utilizing its proprietary vitamin B-12-based CobOral™ Drug Delivery Technology.  Access will develop CobOral formulations for testing by the biopharma company. Though the terms of the agreement have not been disclosed, Access indicated that any successful formulation developed will be jointly owned by the Parties and subject to a subsequent full licensing agreement.
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Access Pharmaceuticals Files Additional IP for Cobalamin Oral Delivery Technology

Furthered Cobalamin-Mediated Formulation Interest Leads to New Patent Filings And CobOral™ Branding

Dallas, TX and New York, NY

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has submitted additional patent applications, covering its Cobalamin-mediated oral drug delivery technology formulations of many global top-100 injectable drugs, as a result of the growing interest surrounding the company’s proprietary oral delivery technology.  The patents cover oral formulations of leading injectables, like bevacizumab (Avastin®), trastuzumab (Herceptin®), adalimumab (Humira®), etanercept (Enbrel®), insulin glargine (Lantus®), and many others.  In addition, Access rebranded its Cobalamin-mediated oral drug delivery technology as CobOral™ delivery technology.
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Access Pharmaceuticals Furthers Progress on its Cobalamin-Mediated Targeted Drug Delivery Platform for siRNA

Proof-of-Principle Data for Proprietary CobaCyte™ Platform in siRNA

Dallas, TX and New York, NY, September 29, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced today that it has made significant progress with its proprietary Cobalamin-targeted drug-delivery program for siRNA therapies.  As a result of the continued advancements made with its Cobalamin program, Access rebranded the targeted-drug delivery technology as CobaCyte™; and submitted additional patent applications for its improved CobaCyte formulations, including siRNA compositions.

Over the past months, Access’ CobaCyte siRNA application has shown significant promise.  In an in vitro siRNA transfection dose-response study, Access’ CobaCyte nanoparticle carriers loaded with an apoptosis-inducing siRNA molecule showed transfection activity in hard-to-transfect cell lines with potentially better toxicity profiles compared to other reagents. Further studies including in vivo gene-knockdown studies are planned. Additionally, Access has initiated a program whereby proprietary formulations of currently marketed chemotherapies will be developed and tested to assess CobaCyte’s ability to enhance drug pharmacokinetics and pharmacodynamics.
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Q & A With Access Pharmaceuticals’ CEO, Jeffrey B. Davis – Part 2: Cobalamin, ProLindac and Thiarabine

In part 2 of his interview with small-cap equity research firm, OutsideIn Research, Access Pharmaceuticals’ CEO Jeffrey B. Davis provided an in-depth look at the Company’s product pipeline.

COBALAMIN ORAL DRUG DELIVERY / TARGETED DRUG DELIVERY TECHNOLOGY

Q: Can you help explain to the readers your Cobalamin platform technology, in simple layman’s terms?

Jeffrey B. Davis: Sure, I can certainly try.  It’s easiest to explain in the context of the Oral Drug Delivery activity ongoing, so I’ll use that first to explain how the technology works.

First, you should know that drugs have to be injected today because the molecule itself is too large, or simply physically too big to get across the digestive tract.  Because they can’t get across your digestive tract, some drugs need to be injected directly into your blood stream.  Clearly, a technology that could transform “injectable” drugs into “oral” or pill forms of drugs would be very helpful to the pharmaceutical industry, and very valuable.
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Access Pharmaceuticals Presents at American Chemical Society Annual Fall Meeting in Boston, MA

DALLAS, TX and NEW YORK, NY, August 24, 2010

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, announced that its Director of Chemistry and Quality, Dr. Ric Zarzycki will give an invited presentation today on the Company’s Cobalamin nanoparticle technology at a thought-leadership symposium being held at the American Chemical Society’s (“ACS”) 240th National Meeting & Exposition, at Boston Convention and Exhibition Center in Boston, Massachusetts, August 22-26, 2010.  The conference symposium titled, “Multifunctional Nanoparticles for Drug Delivery and Imaging”, will focus on the advancement of nanotechnology in the pharmaceutical and diagnostic industries.  Dr. Zarzycki will highlight the distinct characteristics of Access’ Cobalamin nanotechnology and the potential key role it will play in the future treatment of various diseases.
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Access Pharmaceuticals Signs Agreement With Major Biotech Company To Develop Oral Formulations Of Leading Injectable Drug

DALLAS, TX and NEW YORK, NY July 15, 2010

Access Pharmaceuticals, Inc. (OTCBB: ACCP), announced today that it has entered into a pre-licensing feasibility agreement with a leading biotechnology company to develop an oral formulation of its currently-marketed, proprietary injectable drugs.  Access will utilize its proprietary Cobalamin Oral Drug Delivery Technology to develop oral formulations of the drug for pre-clinical testing. Although the terms of the agreement have not been disclosed, Access indicated that any successful formulation developed will be subject to a subsequent full-licensing agreement.
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