RALEIGH, N.C., Aug. 16, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) a pharmaceutical drug development company, highlights a number of achievements disclosed in the Company's quarterly report (Form 10-Q) filed with the Securities & Exchange Commission (SEC) on August 12, 2011 and provides an overview.
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. To continue to meet primary drug development goals, capital resources are focused on continuing to advance the clinical development of DARA's two lead drug candidates, KRN5500, a novel spicamycin derived non-narcotic analgesic for neuropathic pain and DB959, a first-in-class, non-TZD, dual peroxisome proliferator-activated receptor delta-gamma agonist for type 2 diabetes and dyslipidemia.
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.
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.
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.
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.
MRI Interventions, Inc. (formerly known as SurgiVision, Inc.) received FDA clearance for its MRI-Compatible SmartFlow Cannula and MRI announced the completion of a commercial alliance with Brainlab AG.
For more complete information, please visit the new DARA web site (www.darabio.com).
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:
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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
- 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 I 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 1800 peroxisome 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.