Thiarabine Demonstrates A Reduction Of Both Inflammatory And Erosive Disease Parameters In Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 08 Jul 2009 - 1:00 PDT

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ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced new preclinical data demonstrating that thiarabine shows remarkable efficacy in the prevention and treatment of rheumatoid arthritis (RA). In a well-established animal model for RA, an exceptional restoration of joint structure was observed in the studies, which were conducted at Wayne State University School of Medicine and at Southern Research Institute.

As a therapeutic treatment of established disease, thiarabine demonstrated a highly significant, dose-dependent amelioration of arthritis. Thiarabine treatment resulted in a broad inhibition of disease pathology, with reduction of both inflammatory and erosive disease parameters, as well as protection from loss of cartilage matrix proteins. When used as a preventative treatment, thiarabine blocked the development of joint disease at the 60 mg/kg/day dose level and exhibited a significant reduction in disease incidence and severity at 20 mg/kg/day.

In a therapeutic study comparing thiarabine to methotrexate, a commonly used clinical drug for RA treatment, high resolution 3-D images from an X-ray microtomograph were used along with histological scoring to evaluate joint and bone destruction. Thiarabine demonstrated statistically significant anti-arthritic efficacy comparable to that of methotrexate. "The images from X-ray microtomography present a compelling visual representation of diseased vs. treated limbs" commented David Nowotnik, Senior Vice President Research and Development. "We are delighted with the results of the preclinical study which demonstrate a real benefit to the use of thiarabine in RA."

"Our current development focus for thiarabine is for the treatment of hematological cancers," stated Jeffrey B. Davis, President & CEO. "But, we believe these new RA data provide compelling evidence that Thiarabine should be developed for rheumatoid arthritis as well."

Thiarabine is a next generation nucleoside analogue that Access has licensed from Southern Research. It has been in two Phase 1/2 solid tumor trials and was shown to have significant anti-tumor activity. Access is now working with leukemia and lymphoma specialists to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and other indications. "The IND for thiarabine has been transferred to Access and we have a supply of clinical-grade material." continued Dr. Nowotnik. "We should be able to start the study shortly after FDA clearance of the protocol and drug recertification."

Access is actively seeking co-development partners for all applications of Thiarabine.

About Access: 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; and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.

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: clinical trial plans and timelines and clinical results for ProLindac and product candidates acquired in the MacroChem transaction, our ability to execute licensing agreements in the future, Access' plans to continue and initiate clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), 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 Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

Source: Access Pharmaceuticals, Inc