DARA BioSciences Selected to Present the Positive Results of KRN5500 Phase 2 Study at the 5th Annual Therapeutics Summit

RALEIGH, N.C., Sept. 15, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) announced today that the Company has been selected to present the positive clinical data results for KRN5500, its lead compound for Neuropathic Pain, at the 5th Annual Therapeutics Summit to be held September 20-21, 2011 in San Francisco. Linda Jett, MSN, Clinical Director, Drug Development at DARA, will present a poster entitled, "Management of Placebo Response Yields Proof of Concept in Randomized Trial of KRN5500 in Patient with Neuropathic Pain and Cancer."

 

The presentation will provide results from analyses of a recently completed randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate safety and efficacy of a novel spicamycin derivative, KRN5500, in patients with advanced cancer experiencing neuropathic pain. Placebo response in these types of studies often dilutes the ability to detect potential drug effects. The presentation will explore the ramifications of placebo response in randomized, controlled trials for analgesia.

 

It is common that patients respond to the placebo in pain trials where subjective outcome data are collected. Patients want to feel better.

The placebo effect is a normal physiological event and can be as high as 40% to 50%, requiring an even higher drug effect to show a difference. The placebo response can be thought of as background noise, and what researchers look for is a clinical benefit over and above what is in that background. Researchers are often faced with a dilemma: Is the drug a failure or is the placebo response too great to see the drug response? Often clinical trials must be quite large in order to detect the potential benefit of active treatment over placebo. Although this particular trial had only 19 patients, it had a low placebo response, enabling the positive KRN5500 results to be more easily interpreted.

 

The KRN5500 program was recently granted Fast Track designation for treatment of chemotherapy-induced neuropathic pain by the U.S. FDA. The Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical need.

 

Additional information about the conference can be found at www.paintherapeuticsummit.com.

 

About KRN5500 and Neuropathic Pain

 

KRN5500 is a novel non-opioid analgesic agent, a semi-synthetic derivative of spicamycin:(6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl]amino-L-glycer

o-beta-L-manno-heptopyranosyl]amino-9H-purine). Neuropathic pain has multiple etiologies, including direct nerve trauma, infectious disease (e.g., herpes zoster), metabolic disease (e.g., diabetes) and drug-induced neuropathies (e.g., chemotherapy). Chronic neuropathic pain is characterized by an abnormal hypersensitivity to innocuous as well as noxious stimuli, and often persists after initial tissue damage and inflammation appear to have healed. Painful neuropathy is more commonly caused by non-traumatic conditions than by direct nerve trauma.

 

Prevalence of neuropathic pain in patients that have been treated for cancer is reported to be in the range of 40%. Neuropathic pain in this population has multiple etiologies, including side effects from cancer treatments. Chemotherapy-induced Peripheral Neuropathy is the most common cause of neuropathic pain in patients with cancer, and in particular, for those patients receiving multi-agent chemotherapy.

Clinically, neuropathic pain is difficult to manage and can have a profound impact on quality of life. Although this type of pain sometimes responds well to standard analgesic treatments, currently approved therapeutic agents can have intolerable side effects that prevent reaching the most effective dose. Thus, there is continued need to develop safe and more effective drugs to treat chronic neuropathic pain.

 

The FDA recently granted Fast Track Status to DARA for the KRN5500 program for treatment of chemotherapy-induced neuropathic pain. The Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical need.

 

About KRN5500 and Clinical Results

 

KRN5500 is a novel spicamycin derived, non-narcotic/non-opioid, analgesic agent produced by Streptomyces alanosinicus and is being studied for the treatment of neuropathic pain in cancer patients. A completed Phase II (DTCL100), double-blind, placebo-controlled, randomized, dose escalation study yielded positive results. The purpose of the study was to determine safety and efficacy of KRN5500 as treatment for neuropathic pain in patients with advanced cancer and neuropathic pain.

 

KRN5500 met its primary endpoints of safety and reduction of pain and was superior to placebo (p=0.03). Based on the results of this study and the urgent unmet medical need, the NCI entered into a Clinical Trials Agreement with DARA to further study KRN5500 for the prevention and treatment of chemotherapy-induced neuropathic pain in patients with cancer. Under this Agreement the NCI will fund the costs of the study and DARA will supply drug and placebo. This collaborative trial is scheduled to begin during the second half of 2011.

 

About DARA BioSciences, Inc.

 

DARA is a pharmaceutical development company that acquires high quality, promising therapeutic molecules in early stage development (late pre-clinical/Phase I) that has the potential to fill a significant medical need and represents a large commercial opportunity for participation in large and growing markets. The Company expedites development through proof-of-concept in humans (prior to Phase III) for subsequent partnering, sale or out-licensing to large healthcare and pharmaceutical companies. The effective implementation of this strategy has the potential to greatly enhance return on investment by properly designing drug studies that will reduce event risks and cost of the drug development process.

 

Presently, the Company has two (2) lead drug candidates advancing through clinical trials. KRN5500 for the treatment of neuropathic pain in patients with cancer has successfully completed a Phase IIa study.

DB959 for the treatment of type 2 diabetes and dyslipidemia has successfully completed a Phase Ia study and is nearing completion of a Phase Ib study. The Company plans to announce results during Q3 2011.

 

DARA has a number of promising pre-clinical drug candidates for future development and monetization which include:

 

Family of DPPIV Inhibitors - DB160 is a lead dipeptidylpeptidase

(DPPIV) inhibitor. DPPIV is an enzyme that inactivates a key hormone involved in promoting control of blood sugar levels, thus giving people with diabetes better control of their blood sugar levels.

 

Studies have demonstrated that potent DPPIV inhibitors may be beneficial with stem cell transplantation. The cell surface enzyme, DPPIV, is involved in a number of functions, including adhesion, apoptosis, immune regulation, signal transduction, degradation of incertins such as GLP-1 and as a suppressor in the development of cancer and tumors (Boonacker and Van Noorden. Eur J Cell Biol; 2003).

Additional studies have demonstrated that DPPIV is involved with mobilization of hematopoietic stem cells and hematopoietic progenitor cells (Christopherson, Exp Hematol; 2003). In-vitro studies in mice have shown that inhibition of DPPIV activity on donor cells (either through deletion of the protein or through treatment with a DPPIV

inhibitor) enhanced short-term homing, long-term engraftment, and mouse survival (Christopherson et al., Science; 2004).

 

DB900 is a series of compounds which are PPAR g/a/d agonists for the treatment of type 2 diabetes. These compounds activate genes involved in the metabolism of sugars and fats, thereby improving the body's ability to regulate blood sugar. These compounds have the potential to raise good HDL cholesterol, lower bad LDL cholesterol and lower triglycerides. They also have the potential to deliver weight loss.

 

DB200 refers to a series of compounds that are inhibitors of CPT-1 for the topical treatment of psoriasis. This drug candidate has the potential to inhibit inflammation and the proliferation of skin cells, thus resulting in decreased reddening and less flaking of the skin.

This program is currently not being resourced. Should development of DB200 resume, a clinical candidate will be selected from a number of strong lead compounds.

 

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 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.

 

The drug discovery and development process is highly uncertain, and we have not developed, and may never develop, a drug candidate that ultimately leads to a commercially viable drug. Our most advanced drug candidates are in the early stages of development, and we do not have any drugs approved for commercial sale. Before a drug product is approved by the FDA for commercial marketing, it is tested for safety and effectiveness in clinical trials that can take up to six years or longer. Promising results in preclinical development or clinical trials may not be predictive of results obtained in later clinical trials. A number of pharmaceutical companies have experienced significant setbacks in advanced clinical trials, even after obtaining promising results in earlier preclinical and clinical trials. At any time, the FDA may place a clinical trial on clinical hold, or temporarily or permanently stop the trial, for a variety of reasons, principally for safety concerns. We or our collaborators may experience numerous unforeseen events during, or as a result of, the clinical development process that could delay or prevent our drug candidates from being successfully commercialized, including: (1) Failure to achieve clinical trial results that indicate a candidate is effective in treating a specified condition or illness in humans; (2) Safety issues, including the presence of harmful side effects; (3) Determination by the FDA that the submitted data do not satisfy the criteria for approval; (4) Lack of commercial viability of the drug; (5) Failure to acquire, on reasonable terms, intellectual property rights necessary for commercialization; and (6) Existence of therapeutics that are more effective.

 

 

CONTACT: Investor Contact:

Cameron Associates, Inc.

Kevin McGrath

212.245.4577

Kevin@cameronassoc.com

 

Media Contact:

Wyatt Communications LLC

MJ Wyatt

212 661-9610

mjwyatt@erols.com

 

Posted: September 2011

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