Shawshank, VA 8/16/2011 (PennyPayDay) – DARA BioSciences, Inc. (Nasdaq:DARA) filed their 10-Q and the Company issued a press release on their six month results.DARA BioSciences 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.
Operational highlights include:
The manuscript detailing the positive results from the KRN5500 Phase IIa clinical study has been accepted for publication by a prestigious, peer-reviewed medical journal. KRN5500 met its primary endpoints of safety and reduction of pain and performed statistically better than placebo (p=0.03).
DARA plans to initiate an additional Phase II clinical study for KRN5500 in conjunction with the National Cancer Institute in 2011 to study the prevention and treatment of chemotherapy-induced peripheral neuropathy (neuropathic pain) (CIPN). It is estimated that the annual commercial potential for CIPN is $2.5 billion at peak sales.
An article appearing in the April 12, 2011 edition of BioMed Reports-Oncology Nurse Advisor entitled, "Chemotherapy-induced peripheral neuropathy: the pain of surviving cancer" speaks to this serious medical condition and KRN5500 as a potential promising medication.
The Company reported that as of June 30, 2011 it had cash and cash equivalents of $3.4 million with the average monthly burn-rate of approximately $388,000, for the last three months. Management continues to streamline non-drug development expenses and has reduced G&A expenses by 20% from the same period last year.
The promising results from the DB959 Phase Ia study were reported in Q1 2011 and a Phase Ib study is nearing completion. Preliminary results from the Phase Ib study are positive. Presently, the Company is planning on announcing detailed results during Q3 2011. DARA presented the Phase Ia results at the 71st Annual Meeting of the American Diabetes Association, Scientific Sessions in June 2011. A Phase IIa study is planned for 2012. The 2009 sales of non-insulin products to treat type 2 diabetes were $12.2 billion.
The World Health Organization estimates that more than 220 million people worldwide struggle with diabetes and the global cost of diabetes care exceeds $41 billion annually.
Other highlights include:
DARA was invited to present KRN5500 clinical results at the 13th World Congress on Pain and at ADEPT- Accelerating the Development of Enhanced Pain Treatments.
During the first half of 2011, the Company was issued nine new patents in the United States, Europe and other foreign jurisdictions relating to its development pipeline of compounds to treat diabetes and associated conditions including obesity, cardiovascular disease, Syndrome X; and compounds to treat neuropathic pain.
The Company has recently presented at a number of investor based conferences including: the Wall Street Analyst Forum 22nd Annual Analyst Conference, Taglich Brothers - 8th Annual Small Cap Equity Conference, MDB Capital Group - Bright Lights Conference, Noble Financial Capital Markets – Seventh Annual Equity Conference, and the RetailInvestor.com Conference. The Company has been invited to present at the upcoming Rodman & Renshaw Annual Global Investment Conference in September.
To learn more, visit the new DARA web site www.darabio.com or follow them on Facebook.
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