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Zalicus Inc. Message Board

scistats 66 posts  |  Last Activity: 15 minutes ago Member since: Apr 5, 2009
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  • scistats scistats Aug 28, 2014 8:43 PM Flag

    Thanks, I will take a look!

    Sentiment: Strong Buy

  • scistats scistats Aug 28, 2014 4:48 PM Flag

    8 people received Multistem.
    Do the math. Gil knows the results.

    Furthermore, if a safety committee knows the results, a lot more people know.
    Unless you still believe in the tooth fairy.

    Third, the study is now a balanced design between placebo and Multistem.
    Moderate to severe stroke is scored 3-5 on the Rankin scale.
    We already know the outcome for standard of care in terms of the proportion to expect converting to less than or equal to 2, which is the primary outcome measure. So, once again, if you do the math with knowledge of the collective patient outcomes after 90 days, its not too difficult to determine if Multistem is working as the study progresses.

    As the trial moves toward completion of enrollment and more patients complete their 90 day period, the writing will be on the wall for those in the know.

    Sentiment: Strong Buy

  • Athersys recruited 10 stroke patients (Cohort 1 and 2) to evaluate the safety to of high dose Multistem before enrolling the remaining 120 for Cohort 3. More than likely 4 patients received low dose, 4 high dose, and 2 placebo.

    Athersys confirmed the high dose was safe and has moved on to Cohort 3, the large part of the phase 2 currently underway. The question is: Since Cohort 1 and 2 were unblinded to know that those receiving Multistem high dose is safe, what were the results of this preliminary safety evaluation which should give us an idea of whether Multistem is working or not. The 8 patients who received Multistem should have shown better than average progress. Was this the case. Gil has the results. So, what happened to these patients after 90 days???

    Experimental: Cohort 1
    Low dose MultiStem vs. Placebo

    Experimental: Cohort 2
    Low dose MultiStem vs. Placebo

    Sentiment: Strong Buy

  • scistats scistats Aug 26, 2014 12:55 AM Flag

    Not at all Dr. Sumitchawla, I am here, just like you, to debate both sides and seek the truth. You seem to think the odds of Multistem success are far from a slam dunk. Are you long or short this stock? Just curious. Stictly look at the odds, you should be short, so if you are, this is ok.

    I am sure you meant 'infusion' rather than 'injection' of Multistem, and Athersys does not have the resources to remotely beging to fund a phase 3.

    Regarding the current tiral desing. What I am saying is, 'hey lets give credit for a 2 point reduction from 5 to 3 on the Rankin scale in the current trial'. Right now, we do not do this, so I am not following your arguement above. If we can show 2 point reductions, one would assume 4 to 2 reduction will put patients back in the game even if this particular metric eludes us in this particual trial. Do you see the weak link here?

    Had we really rather address reimbursement potential now rather than demonstrate Multistem is effective for reducing stroke symptoms, even if we cannot definitively prove the strict defition of success as reduction equal to or less than a Rankin score of 2 or less with so few patients enrolled in this small overly ambitious phase 2 trial.

    I am a Strong prudent Buy. Bet no more than you can afford to gamble on this peculiar experimental design that insists on absolute perfection, ignores 5 to 3 successes, and accepts nothing less with total failure (just like the UC trial) a likely outcome. Cheers.

    Sentiment: Strong Buy

  • scistats scistats Aug 25, 2014 5:34 AM Flag

    I am long in the five digit range.
    I have about as much exposure as I stand.
    If there was a 'Strong Prudent Buy' option, I would select it.

    Sentiment: Strong Buy

  • scistats scistats Aug 25, 2014 5:11 AM Flag

    Sometime you really do have to laugh. I am pointing out literature references and debating sample size calculations and overestimations of Multistem efficacy and how Gil set the highest bar possible for success. You have to allow for some fun and games along the way. Although, the sinking ship video is a very real possiblity. This is a high stakes gamble.

    Sentiment: Strong Buy

  • scistats scistats Aug 25, 2014 5:06 AM Flag

    Did you see bar that Gil and Pfizer set for the UC trial? Impossible to succeed, and now the readily admit it.

    The most difficult patients with a decade of UC to be cured by a single dose of Multistem. Really?

    The front wheels of the bust have already run over us, now we await the back end as the next high bar stroke trial is set to fail because of being "grossly overoptimistic in their expectation of treatment effect" Stroke. 2004 May;35(5):1216-24

    Sentiment: Strong Buy

  • Reply to

    couldnt help answering scistats as he is wrong

    by isaacandromeda Aug 24, 2014 11:27 PM
    scistats scistats Aug 25, 2014 5:01 AM Flag

    Sorry, Yahoo chopped my message the publication is Stroke. 2004 May 35(5)1216-24.

    "Most [Stroke] trials were underpowered, ie, power less than 0.90, used inappropriate assumptions for event rates, and were grossly overoptimistic in their expectation of treatment effect. These deficiencies will together have resulted in trials being far too small and reduced their chance of being able to detect real treatment effects."

    I think Athersys is both overoptimistic and moving forwad with too small a sample size.

    This is why I want Gil to accomodate all the successful mRS reductions due to Multistem and not just those resulting in reductions to less than 2. Now we have to datamine to prove this, and it is not part of our stated outcome measure. So by definition, Gil has set the highest expectation for success with a relatively small sample size.

    Sentiment: Strong Buy

  • scistats scistats Aug 25, 2014 4:54 AM Flag

    No, Dr. Sumitchawla, this is not what I said at all. Also, your are wrong about spontaneous recoveries. The Athersys trial is waiting 24-48 hours to remove the spontaneous recoveries (the 40% you mention), so we are dealing with the more difficult cases of people mostly over 65 years of age. I am NOT saying a mRS of 2 or less is impossible to achieve, I am saying the number will be few in this difficult group. I am saying we cannot ignore the 5 to 3 mRS reduction successes which Gil threw out with his bogus primary outcome measure. These 5 to 3 reductions may in fact highlight the benefit of Multistem that cannot be revealed by the small patient numbers we have in this small phase 2 study. This trial is, "grossly overoptimistic in its expectation of treatment effect" Stroke. 2004 May 35 1216 24 Furthermore, your eagerness to move on to reimbursement based on phase 2 data is folly. What we need is first, proof of efficacy. Then let the phase 3 prove a 2 or less Rankin for possible reimburesment. You are getting way ahead of yourself when what we want here is a successful phase 2 that survives to even have the chance of moving on to a phase 3.

    Sentiment: Strong Buy

  • Reply to

    couldnt help answering scistats as he is wrong

    by isaacandromeda Aug 24, 2014 11:27 PM
    scistats scistats Aug 25, 2014 4:40 AM Flag

    isaacandromeda, Google the 'Edison Athersys multipotent stem cells report' which is a pdf. It details what dr.sumitchawla is explaining. We have lost some n value to low dose infusions to confirm high dose safety.

    We are on to Cohort 3 which is using the highest safe dose in a 1:1 randomisation to placebo or MultiStem as single IV infusion 24-48 hrs (ideally 24-36 hrs) following ischaemic stroke.

    The primary endpoint is the % of subjects with a modified Rankin Scale (mRS) score of 0-2 after 90 days.

    dr.sumitchawla spoke of sample size. Lets refer to a publication:
    "Inadequate trial design, especially low sample size, may partly explain failure." "Most [stroke] trials were underpowered, ie, power

    Sentiment: Strong Buy

  • scistats scistats Aug 24, 2014 10:03 PM Flag

    Ok, I will contact Athersys and ask them if Multistem achieving any level of statistically significant reduction in Rankin score relative to placebo, is considered a success? Everyone else is welcome to do the same.

    Or, is Multistem achieving a statistically significant reduction in Rankin score relative to placebo considered a success only if that statistically significant reduction relative to placebo results in a score between 0 and 2?

    We know the study will be Multistem (low dose/high dose) vs. Placebo

    I am afraid that the "Measure Title" will be "Number of Patients With a Modified Rankin Scale (mRS) Score of 0-2 at 3 Months." I think this phase 2 study can afford to be broader at this point in terms of defining success because of the small number of patients being evaluated.

    What we need is a breakdown to the following groups and liberty to define success as simply a reduction in mRS relative to placebo, assuming that in the greater population, some patients will reduce to 2 or below, even if this small trial with a split low and high dose treatment cannot demonstrate this subgroup.

    In other words, this study may be too small to prove the primary outcome measure as it is defined, but in reality, some percentage of people will achieve the desired reduction, perhaps 20%? Multistem is more affordable than others because of cell amplification, so benefiting a smaller % is feasible from a insurance reimbursement/cost standpoint.

    This is where I feel Gil is dropping the ball. He is hanging us out to dry with a strictly defined primary outcome measure. I want him to change this and explain why the study was designed in such s threatening way.

    90 day mRS score of 0 overall
    90 day mRS score of 1 overall
    90 day mRS score of 2 overall
    90 day mRS score of 3 overall
    90 day mRS score of 4 overall
    90 day mRS score of 5 overall
    90 day mRS score of 6 overall

    Sentiment: Strong Buy

  • scistats scistats Aug 24, 2014 5:37 PM Flag

    Ohmtaxi, it depends on your definition of success. Lets say Multistem on average reduces Rankin by 1 point. For some patients, going from 4 to 3 would not meet the outcome measure (although still a success in reduction), but for others going from 3 to 2 would meet the trial's definition of success.

    Now, lets say that the Rankin 3 to 2 scenario happens for 25% of those receiving Multistem. For 75% of people, they did not reach the primary outcome measure , but for 25% it is a miracle therapy.

    Ok then, is the trial itself, as a whole, a success? Keep in mind we have 70 patients receiving treatment and split this because we have two doses, high and low.

    Because of all of this, demanding a Rankin score of less than or equal to 2 is the wrong approach and stacks the odds against us when this was not necessary for a phase 2.

    So Ohmtaxi, define what you consider success, compare it to Gil's definition, and hope that he genuinely has our best interest at heart.

    Sentiment: Strong Buy

  • scistats scistats Aug 24, 2014 4:22 PM Flag

    Was he pre-paid in his contract by a means that is yet to unfold or just his high salary to run the circus? Bernie-Land looks to be spot on. I concur. The goal here is to wash, rinse, and then actually move what is likely successful to the market, without the current shareholders. It is as if they are buying time with our money as part of the grand plan.

    Sentiment: Strong Buy

  • scistats scistats Aug 24, 2014 4:18 PM Flag

    Ohmtaxi, I point you to Zalicus and Dr. Mark Corrigan for a historical perspective of what is going to happen to you here. I posted the same video there. Again, please be careful with whatever you do.

    Sentiment: Strong Buy

  • Reply to

    Outcome measure of Rankin 2 or less is TITANIC

    by scistats Aug 23, 2014 7:48 PM
    scistats scistats Aug 24, 2014 4:12 PM Flag

    I posted this same video early on for a company called Zalicus. You can look it up. It was a warning that ZLCS management was taking its stockholder to the cleaners. They bombed two trials of a drug they knew was bogus, and then the CEO slipped into the board of a new company with a nice salary and more shares in exchange for the cash infusion.

    Stockholders were diluted to infinity. Left with nothing. Ohmtaxi, if you are short, it may be the right move. If you are long, invest only what you can truly afford to lose. I genuinely would like to see success here, and I am currently a prudent long and have never shorted a stock in my life. I encourage debate. This is my cheap, desperate, agenda. Honest debate and seeking the truth. I can see a case for being short or long, but mostly for being extremely careful as management maneuvers for themselves.

    Sentiment: Strong Buy

  • scistats scistats Aug 24, 2014 4:02 PM Flag

    The agenda is to debate why failure of the phase 2 Athersys stroke and UC trials were planned and highlight viable alternatives that could have led to success. Then, to further debate why these alternatives were not pursued and the possible motives for designing trials that were highly unlikely to succeed. Then to assign negligence, guilt, or innocence. The only reason such a debate would not be encourage is if one is shorting this stock and likes what is happening, one genuinely believes in miracles, or is in management with a golden exit strategy. I am desperate to shine some light on this matter. This is my agenda. If Gil had left of some room for hope that this trial would succeed, we would not be having this conversation. My opinion is that Multistem can beat placebo but cannot always achieve 2 or less Rankin which is demanded for success. This gives room for the company to dilute and move on under another name with vastly more skin in the game thanks to the destruction of ATHX shareholders. Mesoblast and others are moving forward, MSCs will be used for stroke, the question is who is rewarded for their investment. A snake sheds its skin.

    Sentiment: Strong Buy

  • Lets forget about the impossible goal of achieving a Rankin Score of 2 or less in patients 65+ years of age who failed to recover on their own between 24 and 48 hours, with likely additional underlying health conditions.

    Instead, what if Multistem can simply at least beat placebo in Rankin score OR at least help these people live longer over 2 years relative to placebo?

    Right now, if we reach one or both of these goals, the trial is still considered a failure.

    Success, as currently defined, is not keeping people alive or improving their function somewhat, but curing them with a Rankin score of less than or equal to 2, which means they have to be entirely independent in daily function by 90 days...or else the trial fails as defined by the Primary Outcome Measures.

    Folks, this stinks. This is the only trial design where beating placebo and living longer mean nothing. This will wash us out, dilute us down, and reissue massive shares to management behind the firewall of a new name.

    Sentiment: Strong Buy

  • Reply to

    Outcome measure of Rankin 2 or less is TITANIC

    by scistats Aug 23, 2014 7:48 PM
    scistats scistats Aug 24, 2014 2:46 PM Flag

    Ohmtaxi, they do give you a link 'allowance'. Try it. Post a relevant link, like a sinking ship in this case, and ignore the link warning. It should post.

    I think that you know that I sincerely want Multistem to succeed, but the only way I see this happening (for you and I anway) is to set realistic goal. Achieving a Rankin score of less than or equal to 2 with a study size of 140 split equally with placebo and then split again between high and low dose Multistem, dilutes the statistical power for an already enormously ambitious goal in patients 65+ years of age, who do not show any signs of recovery between 24 and 48 hour (most difficult patients), with likely additional underlying health conditions.

    Keep in mind the definition of success here. A single does of Multistem must return the aged people to complete independence (essential full recovery), regardless of their other health condition compromised or occurring with the stroke, all within 90 days. We are not just charged with beating placebo, Multistem must beat Holy Water. Got it?

    What I am asking for Ohmtaxi is for Athersys to set a reasonable bar for success rather than deliberately wash out stockholders for some pre-arranged strategic alliance whereby Gil is appointed a board member with lucrative pay by some company who buys the "failed" Multistem, only to re-set the bar for success lower and quickly move the platform forward, without the current stock holders. They can achieve this through dilution and issuance of new stock to Gil under the new company name to essentially take a larger piece of the pie. Based on the UC and current trial design, I expect something like this to happen. Gil is taking us to the cleaners, and with the failed UC trial, he already has a lot of stockholder money locked in. The stroke trial will take the rest, and he will walk away with everything. There is no way he loses here.

    Sentiment: Strong Buy

  • scistats scistats Aug 24, 2014 2:25 PM Flag

    Thanks for everyone's responses. In my opinion Ohmtaxi points to the crux of the issue. Can Athersys meet the primary outcome measure or not? Dr. Sumitchawla says Multistem must achieve what is commercially and socially viable by the end of the 90 day observation in the trial design. My question is, what if Multistem is statistically superior to placebo but does not produce a modified Rankin Score of less than or equal to 2?

    Lets say the advantage of Multistem is a solid 1.5 superior outcome on the Rankin scale, with the hope of additional improvement over time, using multiple doses instead of one, or using Multistem in combination. As a patient, I would take the 1.5 lower (better) Rankin score, regardless of the ability to be independent at the 90 day mark. Would you?

    I believe Gil can work with the CRO's to develop the design and decide a primary outcome measure. He is the CEO, and I know CRO managers, they can and do work together, so Gil can contribute input to the trial design. In fact, the limitation to any trial design is usually funding, and Gil has to approve the budget which reflect the number of patients and trial enrollment sites.

    Right now we either achieve 2 or less RS and make miracles happen by putting 65+ (75% of stroke) victims back into society to contribute productively. Keep in mind, Athersys waits 24 to 48 hours before treating to identify the cases that do not improve on their own, so more than likely, we are enrolling aged people with other underlying health conditions, treating them with a single dose of Multistem (either high or low dose) and expecting them, within 90 days, to be able to carry out all usual duties and activities or be able to look after their affairs without assistance...within 90 days. Osiris used to try to spin their Prochymal MSC data, highlighting positive data of a trial but not disclosing the results of the primary outcome. They did this with their heart attack trial. This may be the best we can do here as well.

    Sentiment: Strong Buy

  • scistats scistats Aug 24, 2014 2:48 AM Flag

    Yes, we can fail and STILL have efficacy by beating placebo.
    This is what sucks!
    Why did Gil set the bar so high when there was NO NEED to.

    Sentiment: Strong Buy

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