Positive Results For DARA's DB959 for Diabetes

Newswise — Raleigh, NC -- A new peroxisome proliferator activated receptor agonist currently in development, DB959, will most likely be administered orally once a day, according to a presentation made by researchers recently at the American Diabetes Association’s 71st Scientific Sessions. This would make DB959 unique among medications that treat people with type 2 diabetes. More convenient, effective drugs for diabetes are essential since almost 26 million adults in this country now have the disease, and the CDC has warned that diabetes could affect a third of all adult Americans by 2050. Many of these people have uncontrolled disease; the convenience of taking one effective pill a day could clearly be beneficial.

Well tolerated at high doses

A recently completed escalating dose study by DARA BioSciences, Inc. has tested the single-dose safety, tolerability, and pharmacokinetics of DB959. This first human trial was a randomized, placebo-controlled, double-blind study, and it enrolled 70 healthy volunteers aged 18 to 45 in groups of eight participants each. The first group of volunteers was given 2 mg of DB959. After ensuring that dose was well-tolerated, another group was given 5 mg, the next group was given 10 mg, and then subsequent groups received doses escalating up to 200 mg per day. Both active and placebo groups tolerated the drug equally at all doses; the few adverse effects that were shown were mild and not dose related. The researchers monitored the vital signs of study participants, measured clinical chemistries, performed physical examinations, obtained ECGs and checked their weights regularly to ascertain the presence of edema. Study participants had no moderate, severe or serious adverse reactions, and had no clinically significant changes in vital signs, laboratory parameters, physical exam, nor any ECG changes.

The pharmacokinetic parameters of the drug were consistent with once a day dosing. The drug’s half-life ranged from 14.8 to 19.9 hours over the tested dose range. Other measurements revealed that the drug was not excreted unchanged in urine, and the examination of a possible food effect revealed that a high fat meal only slightly delays the drug’s absorption.

According to Mary K. Delmedico, Ph.D. and her co-authors, DB959 continues to show promise. In addition to demonstrating its long half-life, the current study found that the maximum tolerated single dose of the drug is over 200 mg, which is approximately 10 times the anticipated therapeutic dose range.

Unique PPAR

DB959 is in a different chemical class from the PPAR medications currently on the market, and the drug has demonstrated a favorable effect on blood lipids as well as blood sugar; it raises HDL while lowering both triglycerides and blood glucose. Dr. Delmedico said, “This is an important finding, since most people with diabetes don’t have good control of their lipids. Also, we’ve seen from previous studies that DB959 appears to have less liability concerning weight gain than other PPARs – something we’ll continue to study in Phase 2.”

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 StatementAll 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.

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