RALEIGH, N.C., June 28, 2011 (GLOBE NEWSWIRE) -- Today DARA BioSciences, Inc. (Nasdaq:DARA) announced the positive results of a randomized, placebo-controlled, double-blind, escalating single-dose study to evaluate the safety, tolerability, pharmacokinetics and food effect of DB959Na in healthy male and female volunteers. The presentation provided details on the company's lead oral diabetes drug candidate DB959.
A summary of the study results (DB959-101) follows:
SAFETY
- No moderate, severe, or serious adverse reactions occurred.
- Tolerability was equivalent between active and placebo groups; all doses tested were well tolerated.
- No clinically-significant physical exam, vital sign, blood, urine or electrocardiogram changes were observed.
- Maximum tolerated dose (MTD) for a single dose was not reached in this study. Therefore the MTD is higher than 200 mg., the top dose studied here, and is estimated to be ten times the anticipated human dose.
PHARMACOKINETIC
- PK parameters are consistent with once/day dosing.
- DB959 is not excreted unchanged in the urine.
- A high fat meal slightly delays absorption of DB959.
The safety and PK results of DB959-101 provide support for the continued clinical development of DB959. A second clinical study is nearing completion with results expected to be available during Q3 2011.
About DARA BioSciences, Inc.
DARA BioSciences, Inc. is a pharmaceutical development company that acquires promising therapeutic candidates and develops them through proof of concept (pre-phase III) in humans for subsequent sale or out-licensing to larger pharmaceutical companies. Presently DARA has two drug candidates advancing through clinical development and a series of compounds in preclinical development:
1. KRN5500* for the treatment of neuropathic pain in patients with cancer – successfully completed a phase II study. KRN5500 met its primary endpoints of reduction of pain and safety. It was statistically significantly better than placebo (p=0.03). The company plans to initiate a second phase II this year in conjunction with the National Cancer Institute focusing on the treatment and prevention of chemotherapy induced peripheral neuropathy (CIPN). The NCI will sponsor these studies with DARA only having to supply active drug and placebo; and
2. DB959* for the treatment of type 2 diabetes – successfully completed a phase Ia study. DB959 met its primary endpoints of tolerability with a pharmacokinetic profile pointing to a once-a-day oral drug.
* Cleared IND (Investigational New Drug) application by the United States Food and Drug Administration (FDA)
In addition, the Company has a pipeline of diverse drug candidates at various stages of development, with 88 US and foreign granted patents and 60 pending applications. The first drug candidate KRN5500 has successfully completed a phase II clinical trial treating neuropathic pain in patients with cancer. KRN5500 met its primary endpoint of reduction of pain from baseline and was statistically significantly (p=0.03) better than placebo. A second phase II clinical trial is planned during the first half of 2011. In addition, DARA has entered into a Clinical Trial Agreement with the National Cancer Institute to study the prevention and treatment of neuropathic pain in cancer patients. The second drug candidate DB959 is an oral, highly selective, non-thiazolidinedione (TZD), first-in-class dual peroxisome proliferator activated receptor delta/gamma agonist in development for type 2 diabetes. A phase Ia clinical study has been completed and the positive results were presented at 71st Scientific Sessions of American Diabetes Association meeting in June 2011. A second phase clinical study is nearing completion and the Company plans to announce results in Q3 2011. In addition, DARA owns a series of compounds in pre-clinical development including CPT-1 inhibitors intended for topical application for patients with psoriasis, a library of DDPIV inhibitors and a diverse library of approximately 1800peroxisome proliferator activated receptor agonists of various molecular modalities. These receptors are found throughout the human body and recent publications report that they may be useful in the treatment of Alzheimer's disease, cystic fibrosis, liver disease, and a variety of autoimmune diseases. Because its diverse peroxisome proliferator activated receptor agonists' library, it 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 visit our website at www.darabio.com.
Safe Harbor Statement
All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Those factors include risks and uncertainties relating to DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, risks and uncertainties relating to the potential delisting of DARA's common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA's ability to develop and bring new products to market as anticipated, the current regulatory environment in which the company develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property, the intellectual property of others, and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward -looking statements contained herein to reflect an y change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.