RALEIGH, N.C., Jan. 5, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA), provided additional details from the recently completed Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. As previously announced, the safety of DB959Na was comparable to placebo with no reports of moderate, severe, or serious adverse events in any subjects in the study, and the compound is likely to meet the target dosing regimen of once a day, thus meeting an important goal for the program. New information relates to the additional study objective of determining the maximum tolerated single oral dose of DB959Na. The company announced that subjects in the study tolerated the 200 mg single dose as well as any of the other doses in the study. Therefore, the maximum tolerated single dose is higher than 200 mg, which is well beyond the anticipated therapeutic dose.
The study was a randomized, placebo-controlled, double-blind, escalating single dose study and enrolled 76 healthy male and female volunteers at Quintiles' Phase 1 facility in Overland Park, Kansas. The company plans to present detailed results at an upcoming scientific meeting in the first half of 2011.
As presented earlier, results of preclinical studies demonstrated that DB959 controlled glucose while raising HDL and the HDL:LDL ratio and lowering triglycerides. These beneficial effects on glucose and lipids were observed without causing the weight gain which is seen with other PPAR agonists. Given the positive results seen in this clinical trial, the company plans to initiate a multiple ascending dose trial in the first half of 2011.
About DB959
DB959 regulates certain nuclear receptors (peroxisome proliferator activated receptors, PPARs) that regulate the genes involved in controlling blood sugar levels and certain lipids (e.g. total cholesterol, HDL-cholesterol, triglycerides). The compound acts as an agonist of PPAR delta and PPAR gamma.
About DARA BioSciences, Inc.
DARA BioSciences, Inc. is a Raleigh, North Carolina based biopharmaceutical development company that acquires promising therapeutic candidates and develops them through proof of concept in humans for subsequent sale or out-licensing to larger pharmaceutical companies. Presently DARA has two drug candidates with cleared IND (Investigational New Drug) Applications from the United States FDA. The Company has a pipeline of diverse drug candidates at various stages of development, with 82 granted patents and 56 pending applications (US and foreign). The first drug candidate KRN5500 has successfully completed a Phase 2 clinical trial treating neuropathic pain in patients with cancer. KRN5500 met its primary endpoint and was statistically significantly (p=0.03) better than placebo. A second Phase 2 clinical trial is planned during the first half of 2011. The second drug candidate DB959 is a highly selective, non-thiazolidinedione (TZD), first-in-class dual PPAR (peroxisome proliferator activated receptor) delta/gamma agonist in development for type 2 diabetes. A Phase 1a clinical study for DB959 was successfully completed in 2010 with a multiple ascending dose trial planned for the first half of 2011. In addition, DARA owns CPT-1 inhibitors intended for topical application for patients with psoriasis, a library of DDPIV inhibitors and a diverse library of approximately 1800 PPAR agonists of various molecular modalities. PPAR receptors are found throughout the human body and recent publications report that PPAR agonists may be useful in the treatment of Alzheimer's disease, cystic fibrosis, liver disease, and a variety of autoimmune diseases. Because its diverse PPAR library has the potential to address the unmet medical needs of these diseases, the Company plans to explore several of these indications.
For more information please contact the Company at 919-872-5578 or visit our web site at http://www.darabio.com.