RALEIGH, N.C., Feb. 15, 2011 (GLOBE NEWSWIRE) -- Despite years of efforts by the government and medical associations to educate the public about the dangers of diabetes and the need for a healthy lifestyle, the number of Americans afflicted by this potentially life-threatening disease keeps climbing.
Recent statistics from the CDC (Centers for Disease Control and Prevention) show that almost 26 million Americans now have diabetes, a nine percent increase since 2008. Almost 79 million have "prediabetes." The CDC has warned that if diabetes continues on its current course, it could affect one third of all adult Americans by 2050.
New Medicines Needed
"For people who have diabetes, a healthy lifestyle and the right medication should be an important part of any treatment regimen," explains internist and nephrologist Steve Grossman, MD, a clinician with more than 25 years of drug development experience in cardiovascular, critical care and metabolic diseases, who is medical consultant to DARA Biosciences and Clinical Associate Professor of Medicine at the North Carolina School of Medicine. "But medicines currently available may treat only one part of the problem at a time – high cholesterol, or high triglycerides or elevated blood sugar. That requires the patient to take multiple drugs to control the problem, increasing the chances for drug interactions and side effects."
One medicine in Phase 1 clinical development -- DARA Biosciences' DB959 -- appears to have a positive effect on cholesterol and triglycerides while it also lowers blood sugar – without causing the weight gain seen with other drugs of its type. It is a PPAR (peroxisome proliferator activated receptor) agonist but is in a different chemical class from the PPAR agonist drugs currently on the market.
Although it is in the early stages of development, the pharmacologists working on it think the drug is quite promising. The Company plans to present detailed results about the drug at an upcoming scientific meeting in the first half of 2011.
With greater frequency, large pharmaceutical companies are turning to early stage development companies like DARA as an attractive and affordable option to grown-at-home drug discovery and development (which may cost as much as $1 billion dollars per drug and require more than 10 years from discovery to commercialization) or company acquisitions which may, in the end, have an even higher price tag in terms of financial arrangements, real estate expansions or sales, employee redundancies, operational revamping and drugs that simply don't materialize.
In fact, the Federal government recently announced that, because of the slowness of new drug development and cutbacks in research by large pharmaceutical companies, a new government drug development center will be established.
"Diabetes is the disease most underrated by the U.S. public," explains Richard A. Franco, who has been a pharmacist, senior strategist for a multi-national pharmaceutical giant, an entrepreneur and now, CEO/President of DARA BioSciences. "The general public doesn't have the appropriate fear of diabetes because it can be silent for years – advancing without overt symptoms. But make no mistake about it – it can lead to heart disease, kidney disease, blindness, stroke and death."
Franco cofounded DARA BioSciences in 2003, as a company devoted to identifying and licensing promising early stage development drugs that tackle some of the biggest disease threats. He says DB959's ability to impact lipids and lower blood sugar is novel. Preclinical studies demonstrated a good safety and efficacy profile for DB959. A Phase 1 clinical study determined that single doses of the drug were safe and well tolerated, and that the drug will likely be a once-a-day drug.
For more information, visit www.darabiosciences.com
About DARA BioSciences, Inc.
DARA BioSciences, Inc. (Nasdaq:DARA) is a Raleigh, North Carolina based biopharmaceutical development company that acquires promising therapeutic candidates and develops them through proof of concept in humans for subsequent sale or out-licensing to larger pharmaceutical companies. Presently DARA has two drug candidates with cleared IND (Investigational New Drug) Applications from the United States FDA. The Company has a pipeline of diverse drug candidates at various stages of development, with 82 granted patents and 56 pending applications (US and foreign). The first drug candidate KRN5500 has successfully completed a Phase 2 clinical trial treating neuropathic pain in patients with cancer. KRN5500 met its primary endpoint and was statistically significantly (p=0.03) better than placebo. A second Phase 2 clinical trial is planned during the first half of 2011. The second drug candidate DB959 is a highly selective, non-thiazolidinedione (TZD), first-in-class dual PPAR (peroxisome proliferator activated receptor) delta/gamma agonist in development for type 2 diabetes. A Phase 1a clinical study for DB959 was successfully completed in 2010 with a multiple ascending dose trial planned for the first half of 2011. In addition, DARA owns CPT-1 inhibitors intended for topical application for patients with psoriasis, a library of DDPIV inhibitors and a diverse library of approximately 1800 PPAR agonists of various molecular modalities. PPAR receptors are found throughout the human body and recent publications report that PPAR agonists may be useful in the treatment of Alzheimer's disease, cystic fibrosis, liver disease, and a variety of autoimmune diseases. Because its diverse PPAR library has the potential to address the unmet medical needs of these diseases, the Company plans to explore several of these indications.
About Prediabetes
The American Diabetes Association defines prediabetes - blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes. Recent research has shown that some long-term damage to the body, especially the heart and circulatory system, may already be occurring during prediabetes.
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, the potential delisting of DARA's common stock from the NASDAQ Capital Market, DARA's limited operating history which may make it difficult to evaluate DARA's business and future viability, DARA's ability to retain its managerial personnel and to attract additional personnel, DARA's ability to successfully develop and outlicense its drug candidates 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, potential product liability risks that could exceed our liability coverage, competition from other pharmaceutical companies, biotechnology companies and other research and academic institutions, 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 any 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.