DARA BioSciences (DARA) to Continue KRN5500 Development Following Phase 2a Data

DARA BioSciences, Inc. (Nasdaq: DARA) 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.

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.

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