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Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced that it has initiated the second of two Phase 2a clinical studies with Z160, its first-in-class, oral, state-dependent, selective N-type (Cav2.2) calcium channel blocker for the potential treatment of chronic neuropathic pain. The Company also provided an overview of 2012 accomplishments.
Z160 is designed to selectively target neuronal pain signaling by modulating neurons that are undergoing high-frequency firing. Z160 has demonstrated efficacy in several animal models of neuropathic pain, and clinical trials in over 200 subjects have established Z160 as a safe and well tolerated drug candidate.
The second Phase 2a study with Z160 is enrolling subjects with Postherpetic Neuralgia (PHN), a chronic neuropathic pain state resulting from an outbreak of the herpes zoster virus, otherwise known as shingles. Due to this prolonged neuropathic pain, PHN is an industry-accepted standard condition for establishing clinical proof-of-concept for pharmaceutical product candidates seeking to address neuropathic pain. The 6-week, double-blind, multi-center, randomized, placebo-controlled study is expected to enroll approximately 140 subjects and will be conducted in approximately 35 centers throughout the United States. The primary objective of the trial is to evaluate the efficacy of Z160 compared to placebo in reducing pain in subjects with PHN as measured by the change in average weekly pain score from baseline to week 6 of treatment based on a daily 11-point Pain Intensity Numeral Rating Scale (PI-NRS).
"Postherpetic Neuralgia is an important medical condition for evaluating the activity of Z160 for three important reasons. First, it is a well-recognized standard for establishing clinical proof of concept in neuropathic pain; second, with a prevalence of less than 200,000 patients in the U.S., it has the potential for orphan drug status and could be a feasible first indication to pursue from a commercial perspective; and third, significant unmet medical need exists for novel, targeted and more efficacious chronic neuropathic pain therapies with improved safety and tolerability profiles such as Z160,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus.