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Zalicus AŞ Message Board

  • scistats scistats Nov 1, 2013 9:19 PM Flag

    COMPETITION: Convergence, Relevare Pharmaceuticals, Merck, (not Icagen/Pfizer)

    CNV2197944 is a first in class molecule for the treatment of chronic pain. CNV2197944 is a novel, small molecule, state-dependent calcium channel blocker, designed to selectively inhibit highly active Cav2.2 channels. Preclinical studies demonstrated that CNV2197944 could have analgesic potential for a broad range of chronic pain conditions. Convergence have completed extensive safety and toxicology studies to support the clinical development of CNV2197944, suggesting an excellent margin of safety and tolerability. Phase I, placebo-controlled, single and multiple ascending dose clinical studies with orally administered CNV2197944, demonstrated that the drug was well tolerated in all subjects, with few adverse events reported at doses expected to fall within the predicted therapeutic range. CNV2197944 was well absorbed following oral administration, with a pharmacokinetic profile that is predictable and consistent in both young and elderly subjects. These characteristics indicate CNV2197944’s optimal profile for a chronic pain medication. We have recently initiated two, well powered Phase II proof of concept trials for CNV2197944 in neuropathic pain.

    CNSB004, an N-type calcium channel antagonist, represents a systemically-administered analgesic for the treatment of severe pain that cannot be relieved effectively with strong opioid drugs and current adjuvant therapies. Relevare Pharmaceuticals™' animal data provides compelling evidence indicating that CNSB004's analgesic activity is significantly potentiated when co-administered with opioid or certain non-opioid analgesics. A placebo-controlled Phase IIa clinical trial of CNSB004 in cancer patients with intractable severe pain is positioned to commence in the near future.

    Improved Cav2.2 Channel Inhibitors through a gem-Dimethylsulfone
    Bioisostere Replacement of a Labile Sulfonamide

    ICAGEN/PFIZER: Focusing primarily on sodium ion channels. May compete later.

    Sentiment: Strong Buy

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    • So all working on the same target, calcium channel for the next big pain killer. How much of a head start do we have? Will our patents provide protection?

      Sentiment: Strong Buy

      • 1 Reply to jccfw524
      • jcc, Convergence has ongoing PII trials, till recruiting. Zalicus's trials are over. Just crunching the numbers now. If we succeed at getting positive PII data, we're ahead of them.

        Relevere is still preparing for PII trials. Merk's molecules are at this time preclinical (not reached human testing). So obviously in both those cases we're well ahead.

        The Zalicus patent portfolio is extensive, but only a good science patent lawyer could tell you whether anyone else can shut down specific calcium and/or sodium pathways without infringing. I've written up provisional patents before, but this is way beyond me.

        I can tell you that the most sticky and financially damning problem with patents is one Zalicus is likely not to have. That's infringement. We're not stepping on anyone else's toes. I'm rather sure of that.

        Sentiment: Strong Buy

    • Sci--
      Of note in your post here is that Relevare is testing their Ca+ channel pain drug for cancer. This mirrors what Prialt is primarily used for. Do you think Z160 should have chosen cancer pain instead of LSR for phase 2? That is my fear-- that, despite Z160 being a great drug, they may have over-reached in choosing LSR as the disease to treat.

      • 5 Replies to ranger43a
      • Ranger that may be a signal their drug has side effects that will limit its use. Elan went after morphine resistant cancer patients because Prialt required a shunt and had adverse effects. Severe balance and psych disturbances limited Prialt's use to seriously ill patients. But those AE were acceptable in a cancer pop where the morphine dose had risen so hi that respiratory depression, confusion and constipation become a huge dose limiting problem. It can be so bad that some patients have to daily use their fingers to aid the process of elimination. Its a small market for JAZZ that brings in around $30 million.

      • Z160 targets lower back pain because that's a chronic, neuropathic pain, ranger. (I doubt you'll want to read the literature on this, but if you're interested see Vanegase/Schaible, 2000, "Effects of antagonists to high-threshold calcium channels upon spinal mechanisms of pain, hyperalgesia and allodynia")

        Contrary to what Scistats has posted, the location in the spinal cord of neurons affected by Z160 has nothing to do with why the drug has been selected for low back pain. Again, the firing of a subtype of N-type channels (CaV2.2) that is turned down by Z160 is associated with chronic, neurological and inflammatory pain as opposed to acute pain. Low back pain is a chronic, neurological pain, so Z160 should affect it. That's all.

        Sentiment: Strong Buy

      • Targeting CANCER instead of LSR? Cancer is a small-cap killer. That seems like an insane idea to me. Not saying it couldn't or doesn't work, but cancer is a space I'm scared to enter as an investor. Too many failures, too few successes. Especially when it comes to small-cap, of which there have been exactly ZERO successes in PIII trials. Look up the Feuerstein-Ratain rule.

        Sentiment: Strong Buy

      • It's late, pardon my grammar! I meant to say above "Did Zlcs choose the optimal disease --LSR-- for their phase 2 Z160 trial?"

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