External Data Analysis Confirms Earlier Published Drug Efficacy Signal in Patients With Treatment-Refractory Neuropathic Pain
DARA to Continue Phase 2 Development Program After Formulation Refinement
RALEIGH, N.C., May 9, 2012 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) (the "Company" or "DARA") announced today that it will advance development of its novel Phase 2 drug candidate for the treatment of neuropathic pain in patients with cancer. DARA's decision to proceed was based on an additional in-depth analysis of Phase 2a data from a study previously reported in the October 2011 on-line edition of Journal of Pain and Symptom Management. The new analysis was conducted by an external biostatistician with extensive FDA experience. Previous analyses of the study data were based predominantly on patient-reported Numeric Rating Scale (NRS) pain scores collected by healthcare professionals in a clinic setting during weekly visits, whereas this new analysis focused specifically on self-reported daily pain scores from patients' diaries. Responders in this analysis were defined as patients attaining a clinically-meaningful (at least 20%) improvement in mean NRS scores from baseline within any given week. Of the 12 patients who received KRN5500 in this 19-patient trial, 7 (58%) were classified as responders. Further, 5 of the 7 (71%) showed sustained pain relief over several weeks. Of the 7 patients who received placebo, none were responders. Therefore, the new analysis showed a temporal consistency of pain relief in a larger fraction of patients than had been noted in the earlier analysis of weekly clinic-reported pain. These findings are impressive since patients enrolled in this proof-of-concept trial had unrelenting pain at baseline despite the concomitant use of other approved analgesic agents.
"There are very few effective treatment options for patients with cancer and neuropathic pain, making this an area of significant unmet medical need," stated David J. Drutz, M.D., CEO of DARA. "We are further encouraged by this additional analysis that has shown persistence of KRN5500 pain relief in many patients despite only once-weekly intravenous administration."
A new, improved and easier to use formulation of KRN5500 is under development with a leading firm with expertise in intravenously administered products. DARA believes that this reformulation could address some of the nausea and vomiting observed during the 2a clinical trial. Further Phase 2 studies with this new formulation are being planned in addition to previously announced planned studies with the National Cancer Institute (NCI). Planned Phase 2 studies will also evaluate higher doses of KRN5500 to determine the full extent of the dose-response relationship with the potential for improving the percentage of responders and the duration of effect. KRN5500 has received Fast Track designation by the FDA; such designation is reserved for drugs such as KRN5500 which are intended to address unmet medical needs in patients with serious diseases.
Dr. Amy Abernethy, Director of the Duke Cancer Care Research Program (DCCRP) and a coauthor on the original published paper, stated, "I am very encouraged to see that DARA is pursuing further development of this potentially extremely important addition to the cancer care armamentarium, one that could play a major role in improving the quality of life with this difficult disease and treatment complication." As noted by Dr. Drutz, "KRN5500 fits perfectly into DARA's new strategy as an oncology and oncology support therapeutics company. Indeed, the further successful development of KRN5500 represents a significant potential value inflection point for our investors."
To assist in the development process of KRN5500, DARA has created a Clinical and Scientific Advisory Board. Among advisors named to the Board are Lee S. Simon, M.D. and Allan M. Green, M.D., Ph.D. Dr. Simon served previously as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products and has extensive experience as a senior investigator for celecoxib in the U.S. Dr. Green is well known for his Issues and Commentary Series that analyzes competitive commercial aspects and potential markets for emerging pharmaceutical technologies. Both physicians are founding members of SDG, LLC, located in Cambridge, MA. SDG is comprised of FDA regulatory and strategic planning experts who collaborate on both the design and development of clinical programs. DARA expects to name other advisory board members in the immediate future.
Given the potential breadth of the cancer-related neuropathic pain market and the recent clinical trial failure of two major drug candidates in this area, DARA believes that KRN5500 could satisfy a significant unmet medical need. To fully exploit the potential to develop and commercialize this compound on a global basis the company is actively engaged in partnering/co-development discussions with a number of potential strategic partners.
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA holds the exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen, a product used widely in the treatment and prevention of breast cancer. Soltamox® is the only FDA approved oral liquid version of tamoxifen and fulfills a vital clinical need for patients who cannot tolerate existing tablet formulations of this drug. DARA plans to begin marketing Soltamox® in the U.S. in the third quarter of 2012.
DARA has also obtained exclusive U.S. commercial rights from Innocutis Holdings, LLC for Bionect® (hyaluronic acid sodium salt, 0.2%) within the oncology and radiation oncology marketplace. Bionect® is an FDA-cleared product indicated for the management of irritation of the skin as well as first and second degree burns. Bionect® is currently being promoted and sold by Innocutis in the dermatology market. DARA plans to launch this product in 2Q 2012.
DARA is also developing KRN5500, for the treatment of neuropathic pain in patients with cancer. KRN5500 has successfully completed a Phase 2a study and has been designated as a Fast Track Drug by the FDA. We are working with the National Cancer Institute (NCI) to design an additional clinical trial under joint DARA-NCI auspices while considering further internal Phase 2 development.
In addition, DARA's pipeline includes DB959, a novel, non-TZD dual delta/gamma PPAR agonist for the treatment of type 2 diabetes and dyslipidemia. DARA has completed Phase I testing of DB959 and is presently pursuing opportunities to out-license this product. DARA also has rights to other PPAR and DPPIV-inhibitor compounds for which it intends to seek out-licensing or partnering opportunities.
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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 the closing of the offering described in this news release, DARA's ability to timely commercialize and generate revenues or profits from Bionect®, Soltamox® or other products given DARA's lack of a current sales force and lack of history as a revenue-generating company, FDA and other regulatory risks relating to DARA's ability to market Bionect®, Soltamox® or other products in the U.S. or elsewhere, DARA's ability to develop and bring new products to market as anticipated, DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, 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 and the intellectual property of others, the potential delisting of DARA's common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA's ability to successfully integrate Oncogenerix 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.