$DARA Presented Positive Results Of Its Phase I Study For DB959 At The Amer Diabetes Assoc Scientific Session

RALEIGH, N.C., June 28, 2011 (GLOBE NEWSWIRE) -- Today DARA BioSciences, Inc. (Nasdaq:DARA - News) 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.