Access Pharmaceuticals, Inc. announced earlier this morning new preclinical data demonstrating that thiarabine, one of the companyâ€™s advanced drug delivery technologies, shows extraordinary efficacy in preventing and treating rheumatoid arthritis (RA). In a well-established animal model for RA, a remarkable restoration of joint structure was observed. The studies were conducted at Wayne State University School of Medicine and at Southern Research Institute.
According to the press release, 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 considerable reduction in disease incidence and severity at 20 mg/kg/day.
Perhaps even more exciting, 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. The comparison showed thiarabine had statistically significant anti-arthritic efficacy versus 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, a next generation nucleoside analogue that Access has licensed from Southern Research, has been in two Phase 1/2 solid tumor trials and was shown to have significant anti-tumor activity. The pharmaceutical company 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.” added Dr. Nowotnik. “We should be able to start the study shortly after FDA clearance of the protocol and drug recertification.”
Currently, Access Pharmaceuticals is focused on identifying co-development partners for all applications of Thiarabine.