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Zalicus Inc. Message Board

  • scistats scistats Sep 11, 2013 11:24 PM Flag

    Garrett, can you call Renz? When did Z160 LSR complete enrollment? The exact date please.

    When did LSR complete enrollment? It was BEFORE Sept. 3rd!

    Zalicus Completes Patient Enrollment in Two Phase 2 Clinical Studies of Z160 for Chronic Neuropathic Pain

    Top-line Data for Both Lumbosacral Radiculopathy and Postherpetic Neuralgia Expected in the Fourth Quarter of 2013

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 3, 2013-- Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced that it has completed patient enrollment in two Phase 2 clinical studies of Z160 for chronic neuropathic pain indications including lumbosacral radiculopathy and postherpetic neuralgia. Top-line results of both studies are expected in the fourth quarter of 2013. Z160 is a first-in-class, oral, state-dependent, selective N-type calcium channel (Cav 2.2) blocker in development for chronic neuropathic pain.

    Lumbosacral radiculopathy (LSR) is a common neuropathic pain condition resulting from the compression or irritation of the nerve roots exiting the lumbar region of the spine. Common symptoms include pain radiating from the lower back and down the legs, as well as numbness and tingling in the lower extremities. The randomized, double-blind, placebo controlled clinical study, evaluating Z160 as compared to placebo in approximately 140 subjects in 25 clinical sites in the United States, was initiated in the third quarter of 2012. The primary efficacy endpoint for this study is the change in weekly pain scores on a numerical rating scale. Other endpoints include multiple other pain, functional and safety measures.

    Postherpetic neuralgia (PHN) is a painful neuropathic condition resulting from an outbreak of the herpes zoster virus, otherwise known as shingles. The randomized, double-blind, placebo controlled clinical study, evaluating Z160 as compared to placebo in approximately 140 subjects in 55 clinical sites in the United States, was initiated in the fourth quarter of 2013.

    Sentiment: Strong Buy

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    • yes

      i will follow-up tomorrow AM

      • 1 Reply to garrettklein87
      • Thanks Garrett.
        I hope Captain is planning an October surprise for us.
        I look forward to any news Mr. Renz may be willing to share, especially if Lumbo completed enrollment mid/early August! Every day counts, and this time frame would make analysis of 140 pain surveys well within the realm of possibility. Its a small trial after all.

        Sentiment: Strong Buy

    • May help...

      Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy

      ClinicalTrials.gov Identifier:
      NCT01655849
      First received: July 26, 2012
      Last updated: September 5, 2013
      Last verified: September 2013

      Estimated Enrollment: 140
      Study Start Date: August 2012
      Estimated Study Completion Date: December 2013
      Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

      • 1 Reply to jakobi007
      • Thanks, but unfortunately this does not help because ClinicalTrials.gov did not make changes reflecting completion of enrollment of both trials until September 6th (Changes to NCT01655849 on 2013_09_06/Active not recruiting). Please refer to the Zalicus press release, and you will see Zalicus made the announcement on September 3, 2013. The question is: Both trials did not complete enrollment on the same day. So what is the exact date that the Lumbo trial (the first trial) completed enrollment. This is very critical because if it is on or before August 23rd, Corrigan can release news and hopefully avoid a reverse split.

        Sentiment: Strong Buy

    • Read the press release on the Zalicus website, "Top-line Data for Both Lumbosacral Radiculopathy and Postherpetic Neuralgia Expected in the Fourth Quarter of 2013" If the Postherpetic Neuralgia trial is two month behind Lumbosacral Radiculopathy, what does this tell us?

      Also, did you notice that Zalicus conveniently avoid telling the exact date on which the Lumbosacral Radiculopathy trial finished enrollment? I am guessing before August 23rd. If so, Dr. Corrigan has an opportunity to release data and avoid a R/S.

      Sentiment: Strong Buy

 
ZLCS
1.180.00(0.00%)Jul 15 3:59 PMEDT

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