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Zalicus Inc. Message Board

rul6t2 237 posts  |  Last Activity: Feb 7, 2014 12:53 PM Member since: Jun 16, 2010
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  • Reply to

    Price movement

    by market_ace Feb 7, 2014 11:16 AM
    rul6t2 rul6t2 Feb 7, 2014 12:53 PM Flag

    With any luck it's a leak. I'm hoping for info on the FDA hold being cleared very soon. If news comes out tomorrow, we'll know that was it.

  • Reply to

    IMUC CEO - where is he now ??

    by johnkkhenderson Dec 18, 2013 1:13 PM
    rul6t2 rul6t2 Dec 18, 2013 2:39 PM Flag

    Um, he's buying the company's stock on the open market. That's where he is.

    Sentiment: Buy

  • rul6t2 rul6t2 Dec 11, 2013 2:45 AM Flag

    There's no doubt that Dr. Frost is impressed and is putting some skin in the game too. That's the right read on the whole matter.

    But RXi is not listed as one of OPKO's strategic investments on their website for a reason. We invested in their tech, not the other way around. (Except to the extent that Frost is making a personal bet on Rxi.)

    The only other thing to understand here is that Frost owns 20% of RXi now, and that's put him in a good position to buy Rxi out (at a premium, of course). Which would give him all his previous RNAi IP right back again. Not a bad position to be in.

    Sentiment: Strong Buy

  • rul6t2 rul6t2 Dec 10, 2013 9:55 PM Flag

    The Opko deal is an inlicence deal from the POV of Rxi. We pay THEM, and only IF we succeed in developing and commercializing applications related to their patents.

    In terms of this particular deal then, they are the tail. We are the dog. Nothing they do on their end can make us succeed at turning their patents into products. So nothing they do or say should ever affect our stock price.

    Sentiment: Strong Buy

  • With all the necessary caveats that apply to animal models and what they can or can't tell us regarding human application of a therapy or drug, here's a good study to check out--

    search for the terms: hypertrophic scarring CTGF sisco

    You'll find at the top of your results list an abstract of the study "Antisense inhibition of connective tissue growth factor (CTGF/CCN2) mRNA limits hypertrophic scarring without affecting wound healing in vivo."

    This study is good proof of concept. This standard rabbit model (which has been used for preclinical work on human scarring in a number of studies) is reliably predictive. Again, with the usual caveats. Weird #$%$ happens from time to time with animal models.

    I have read the full paper. In this study, the hypertrophic scarring was reduced significantly by a 55% knockdown of the same gene, i.e., CTGF, targeted by RXi. That compares very favorably to the RX-109 knockdown rate of up to 50%.

    Interesting to note that in vitro knockdown rate for the antisense agent used here was 92%. The in vivo, rate was therefore much lower (probably a good thing for reasons well addressed on this board already). And yet scar reduction was still very good. One timing strategy for injection (similar to one being used by RXi in current PII design) reduced scar height by 53%.

    All very good signs

    Sentiment: Strong Buy

  • Reply to

    News out! Phase I complete

    by sumtin14nic Dec 5, 2013 9:29 AM
    rul6t2 rul6t2 Dec 5, 2013 12:37 PM Flag

    "Exactly cobra"?

    Cobra, just explained why and how you were wrong. You wrote that you were disappointed in the 50% knock down rate. Cobra just pointed out that it would be unproductive to have a higher rate for this indication.

    What's your game?

  • Reply to

    News out! Phase I complete

    by sumtin14nic Dec 5, 2013 9:29 AM
    rul6t2 rul6t2 Dec 5, 2013 12:34 PM Flag

    If your'e "quite disappointed" in the latest data, it's because you don't understand them. That's all. Do a bit more research my friend. You'll feel better.

    Sentiment: Strong Buy

  • Reply to

    secondary endpoint in the PI trials

    by thalio Nov 26, 2013 12:49 PM
    rul6t2 rul6t2 Nov 26, 2013 3:17 PM Flag

    Put in a call to Ms. McGrillen. I'll update the board when I get clarification.

  • Reply to

    secondary endpoint in the PI trials

    by thalio Nov 26, 2013 12:49 PM
    rul6t2 rul6t2 Nov 26, 2013 2:03 PM Flag

    Your point about PI trials being safety trials is accurate. I've wondered, though, if we don't get a little something more from incision investigations like these.

    Normally PI is done with healthy volunteers. But you can't do that if you're trying to assess the safety of wound closure. You have to make an incision. And that will or will not leave a scar to some degree. No way around it.

    We already have pictures and analysis from an earlier PI that shows some scar reduction. I don't know if that was a secondary outcome of that trial. If anyone does, please chime in.

    What I'm still very curious about is whether scar reduction as such is a secondary outcome of the two current trials. Again, the photos are going to be "captured and assessed by a masked, independent, expert panel."

    Assessed for what? Just wound closure, or also scar reduction? It would be helpful to know with some certainty if that is at all possible.

    Maybe this is a question for the company, as this detail surely isn't meant to be obscured from the public.

  • Reply to

    anecdotal results and photos

    by thalio Nov 25, 2013 4:14 PM
    rul6t2 rul6t2 Nov 26, 2013 12:32 PM Flag

    Thanks, rmsacc.

  • Reply to

    anecdotal results and photos

    by thalio Nov 25, 2013 4:14 PM
    rul6t2 rul6t2 Nov 26, 2013 2:55 AM Flag

    Right. And that would also be the kind of anecdotal data that could really get people charged up.

  • Reply to

    anecdotal results and photos

    by thalio Nov 25, 2013 4:14 PM
    rul6t2 rul6t2 Nov 25, 2013 6:44 PM Flag

    Sorry, that should read "could't be accepted by the FDA"

    Not sure why this question rates several thumbs down. Did I miss something?

  • Reply to

    Sorry for our losses, everyone.....

    by ranger43a Nov 11, 2013 10:19 AM
    rul6t2 rul6t2 Nov 11, 2013 10:51 AM Flag

    I made my bet. And given all the indicators that this pathway was promising and this molecule was hitting it solidly. Can't forget that this was always a possibility despite all the positive indicators.

    I will have to reevaluate for the future what having all those preclinical data, data on a similar already approved drug, and data from earlier clinical data all add up to. Clearly it didn't spell success.

    I wish all investors well in going forward.

  • Reply to

    new article on Xcnomy

    by dotcom55 Nov 11, 2013 2:25 AM
    rul6t2 rul6t2 Nov 11, 2013 4:37 AM Flag

    We will not know how "powerful" Z160 is until trial results. There ARE no extant studies that could that anyone that. I know. I have studied them all. The animal studies suggest very powerful analgesia, but we still have to wait for human confirmation.

    LSR patients for this study, probably for the very first time, were tested beforehand to zero in on neuropathic pain as the true etiology. In the past, other company's LSR studies most likely lumped in all kinds of pathology that resulted in lower back pain. For that reason Z160 has a real shot at treated this subjects in this trial. It's a tribute to Dr. Versavel's expertise that these tests were done to help cull out patients the Z160 might be less likely to help.

    Sentiment: Strong Buy

  • rul6t2 rul6t2 Nov 10, 2013 10:23 PM Flag

    (PART TWO)

    WHAT WERE FACTORS THAT CONTRIBUTED TO HIGH PLACEBO EFFECT IN PHN TRIALS?

    With post-herpetic neuropathy there was a correlation between having had recent outbreaks of shingles and those patients with high placebo response. The pain of a recent outbreak can diminish on its own.

    In the Z160 study ANY PATIENTS WITH LESS THAN SIX WEEKS TIME POST OUTBREAK HAVE BEEN EXCLUDED FROM THE STUDY. Again, this is a smart design, and more evidence of Dr. Versavel knowing his stuff.

    ARE THERE CERTAIN PAIN PARAMETERS THAT HISTORICALLY REDUCE PLACEBO RESPONSE IN CLINICAL TRIALS?

    Yes, they are--

    Pain that is rated as very high or rather low. Both tend to respond well to placebo. You don't want either. The Z160 studies require pain scores (PI-NRS) BETWEEN 3 AND 8.

    High fluctuation in pain for lower back pain (LSR). You don't want it. Z160 trials for LSR inclusion criteria states subjects must have had STABLE LEVELS OF PAIN for the preceding two weeks.

    Reports of somatic or body pain. For whatever reason these people tend to be correlated with higher placebo response. You don't want them. Z160 trials SCREEN OUT APPLICANTS WITH HIGH SELF-REPORTED SOMATIC PAIN.

    The take away is this. There are known problems with placebo effect in neurological pain trials. But there are also known procedures in trial design for reducing them. Zalicus has those procedures in place. That is no doubt the doing of Dr. Mark Versavel and not surprising given his excellent track record of previous successful drug trials over several decades.

    Sentiment: Strong Buy

  • The responsibility for minimizing placebo effects that could skew results in Z160 trials is that of Dr. Mark Versavel.

    Dr. Versavel rates as a world class central nervous system (CNS) drug trial designer based on experience and success rate. He has stewarded a number of drugs through successful trials at stages from one through four (stage four trials are for extended application of licensed drugs). This includes the blockbuster drug Lyrica. Dr. Versavel was responsible for the trials that extended Lyrica's on label use to certain neuropathic pain indications.

    I won't go into any more detail on Versavel's background in part because it's already been covered on this board and also because it's very easy to look that up yourself. That's the kind of DD you ought to be doing anyway. Let's just look at what he's done.

    CHALLENGES IN NEUROPATHIC PAIN TRIAL DESIGN

    We heard through Mr. Jason Napodano last week about the difficulties inherent in rising above the noise of placebo effect in neuropathic pain trials. It's a real concern, and well known in the pharmaceutical industry.

    But some things have been learnt in the last five years about this challenge, including ways to help surmount it. And the good news is these design factors appear to have been included in the Z160 trials. Being familiar now with Dr. Versavel's record of excellence this is no surprise.

    WHAT FACTORS CAN CONTRIBUTE TO FAILURE IN PAIN TRIALS DO TO HIGH PLACEBO EFFECT?

    Longer pain drug trials have higher placebo effect. Why? We don't know. It's just a statistical fact that shows up when meta-analysis is done on numerous pain studies. Pregabalin failed a fourteen week study for diabetic peripheral neuropathy (DPN) back in 2009 due to unexpectedly high placebo effect.

    Z160 PAIN TRIALS ARE SHORTER TRIALS. The Z160 studies are not twelve or fourteen week studies. They are SIX WEEK STUDIES. I have little doubt this was done to reduce the chances of high placebo effect.

    Sentiment: Strong Buy

  • Reply to

    HAS MARK VERSAVEL GOT HIS GAME ON?

    by tabecounted1 Nov 9, 2013 12:35 PM
    rul6t2 rul6t2 Nov 9, 2013 3:38 PM Flag

    We've talked a lot on this board about what we can and can't say fairly about the chances of trial success here. Maybe it's time to do a summary. Give me a little time on that.

    You want to know my bottom line? There's no way for anyone to confirm this so you'll have to take my word on what I write next. I tend to be conservative in my biotech investments, but I'm making an uncharacteristically large (long) play based on the success of these trials.

    That said, people shouldn't invest what they can't afford to lose betting on the outcome of ANY drug trial. Nor should they take anyone else's judgement or advice as a substitute for due diligence.

    Sentiment: Strong Buy

  • Reply to

    HAS MARK VERSAVEL GOT HIS GAME ON?

    by tabecounted1 Nov 9, 2013 12:35 PM
    rul6t2 rul6t2 Nov 9, 2013 1:44 PM Flag

    Dr. Versavel joined Sunovian after Lyrica approval, but he was involved in trials on that drug for further indications including neuropathic pain. His credits are extraordinary, and I'll get to them.

  • Reply to

    HAS MARK VERSAVEL GOT HIS GAME ON?

    by tabecounted1 Nov 9, 2013 12:35 PM
    rul6t2 rul6t2 Nov 9, 2013 1:20 PM Flag

    I've been looking into Dr. Versavel. What I find on this CNS expert and designer of the Z160 trials is extremely encouraging. I'll post something at length tomorrow on him and also trial design challenges for neuropathic pain and what's been learned (and incorporated into the Z160 trial).

    Sentiment: Strong Buy

  • Reply to

    Z160 results date confirmed.

    by amit_rathii Nov 5, 2013 9:52 PM
    rul6t2 rul6t2 Nov 6, 2013 12:03 AM Flag

    Who is this guy and what's he up to, ino? No one has that intel.

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