Thiarabine Demonstrates a Reduction of Both Inflammatory and Erosive Disease Parameters...

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Tue Jul 7, 2009 9:01am EDT

Thiarabine Demonstrates a Reduction of Both Inflammatory and Erosive Disease
Parameters in Rheumatoid Arthritis
ACCESS TO EVALUATE FURTHER DEVELOPMENT OUTSIDE HEMATOLOGICAL CANCERS

DALLAS, July 7 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC
Bulletin Board: ACCP) announced today 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. 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:
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.

    Contact: Company                Contact: Investor Relations
    Stephen B. Thompson             Donald C. Weinberger/Diana Bittner (media)
    Vice President                  Wolfe Axelrod Weinberger Assoc. LLC
    Chief Financial Officer        (212) 370-4500
    Access Pharmaceuticals, Inc.
    (214) 905-5100


 

SOURCE  Access Pharmaceuticals, Inc.

Stephen B. Thompson, Vice President, Chief Financial Officer of Access
Pharmaceuticals, Inc., +1-214-905-5100; or investors, Donald C. Weinberger, or
Diana Bittner (media), both of Wolfe Axelrod Weinberger Assoc. LLC,
+1-212-370-4500, for Access Pharmaceuticals, Inc.
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