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Cyclacel Pharmaceuticals, Inc. (CYCC) Message Board

lifetolive7 166 posts  |  Last Activity: Dec 20, 2014 8:30 AM Member since: Dec 6, 2010
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  • lifetolive7 lifetolive7 Dec 20, 2014 8:30 AM Flag

    Winston, they are brilliant but in my opinion somebody made a big mistake. The effect of the entrance criteria on the early part of the curve should have been better analyzed and considered. After all Esai obviously did in 016.

  • lifetolive7 lifetolive7 Dec 20, 2014 8:20 AM Flag

    In the case of SEAMLESS we only had 46 patients from an un-randomized phase3 pilot/ Lead In which became irrelevant. In retrospect, I believe there should have been some RANDOMIZED data on the SAP DAC combination before SEAMLESS was launched.

    Sentiment: Hold

  • lifetolive7 lifetolive7 Dec 20, 2014 7:43 AM Flag

    In the case of RMDS, there will not be a futility analysis. However in the wake of SEAMLESS, investors should get an early view with a representative pilot/ lead in. There must be more transparency , and consistency.

    Sentiment: Hold

  • lifetolive7 lifetolive7 Dec 20, 2014 7:25 AM Flag

    Murdocs, I agree with what you are saying here and I think we have a good shot for approval with the end of curve data. I think investigators are seeing curve separation later as one would expect with SAP/ DAC. However, I think it was very poor scientific procedure to not keep the main trial participants more consistent with the pilot/Lead in population and visa versa. Clearly they are a different population. Many investors including myself based important decisions from the lead in /pilot. In the end, the pilot/ lead in data has been rendered irrelevant. This is a credibility issue with me. In RMDS development, investors should DEMAND a better controlled, randomized pilot/ Lead in so investors are not blindsided again. Steps should be taken to assure that the patients are taken from the same pool, in the same way, by the same institutions, in the same basic locations so that it is better representative of what will be seen in the main trial. After all, the Lead/ in Pilot is supposed to give a perspective view of the trial. I don't know who is to blame here, but by my perspective somebody did not follow good scientific procedure. In my opinion, If we had stayed with a healthier population such as 016 or the SEAMLESS pilot/ LeadIn, we would have had curve separation right out of the box at 60 days and we would have passed futility. This has caused a lot of harm. Steps should be taken to stop this from happening again in RMDS. In retrospect, I think if there have been provisions to filter out the really sick patients as they did in 016, we wouldn't be in this position now. Somebody at Cyclacel or MD Anderson made a poor decision that put investor capital at risk..

    Sentiment: Hold

  • So we learn to pick ourselves back up ( Alfred From the BatMan Movie).

    Sentiment: Hold

  • "At this stage all patients should stay on study," said Hagop Kantarjian, M.D., Chairman & Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and chair of the SEAMLESS study. "It is essential that we have complete follow-up of all patients to ensure that the mature survival data does not miss any potential survival benefit in the overall patient population or subgroup of patients."

    Sentiment: Hold

  • Reply to

    math/stats thought

    by valueinvestor411 Dec 18, 2014 11:15 PM
    lifetolive7 lifetolive7 Dec 19, 2014 7:59 AM Flag

    It's a basic principal at work here, once you get past the patients that have no chance, you can begin to see what the drug can do. I wonder if this was Dr K's idea to include everybody. I would like to know. Regardless a case could be made on humanitarian grounds in front of ADAC if the end of curve data is as strong as I suspect. It's a good move to finish SEAMLESS.

    Sentiment: Hold

  • Reply to

    math/stats thought

    by valueinvestor411 Dec 18, 2014 11:15 PM
    lifetolive7 lifetolive7 Dec 19, 2014 7:44 AM Flag

    A small filter to remove the patients with no chance at the beginning of the study would have been wise. This is why Esai had the "90 day expected survival requirement".

    Sentiment: Hold

  • Reply to

    math/stats thought

    by valueinvestor411 Dec 18, 2014 11:15 PM
    lifetolive7 lifetolive7 Dec 19, 2014 7:39 AM Flag

    We allowed the oldest, the sickest, and the weakest in the SEAMLESS study. That's probably why we enrolled quicker than 016. In hindsight, I think it was a mistake.

    Sentiment: Hold

  • Reply to

    math/stats thought

    by valueinvestor411 Dec 18, 2014 11:15 PM
    lifetolive7 lifetolive7 Dec 19, 2014 7:34 AM Flag

    Base, not meeting the SPA requirement would put us squarely at the discretion of the FDA and EMA. We always are but the outcome is far less certain.

    Sentiment: Hold

  • Reply to

    math/stats thought

    by valueinvestor411 Dec 18, 2014 11:15 PM
    lifetolive7 lifetolive7 Dec 19, 2014 7:23 AM Flag

    Value I understand that larger sample sizes are more valid . But data from 46 patients cut almost in half? Also, the numbers are low for 016 as well.

    Sentiment: Hold

  • Reply to

    math/stats thought

    by valueinvestor411 Dec 18, 2014 11:15 PM
    lifetolive7 lifetolive7 Dec 19, 2014 7:12 AM Flag

    Value, I agree , the tail data will have a much bigger impact in the back of the study. This why Dr K made comments about complete follow up.

    Sentiment: Hold

  • Reply to

    math/stats thought

    by valueinvestor411 Dec 18, 2014 11:15 PM
    lifetolive7 lifetolive7 Dec 19, 2014 3:47 AM Flag

    The 30% survival number at 6 months is pretty supportive of the low metric geographic tendencies of the US. I think the underlying MOS for Dacogen could be around 3.5-3.8 months in the SEAMLESS population compared to 4.6 months in DACO-016. This is age adjusted down for the older population and adjusted down for the tougher SEAMLESS population. If 50% of patients are dead in the DAC arm at 3.5-3.8 months, it is conceivable ( considering that slope) that 75% of DAC patients are dead at 6 months. To average 30%, that would place SAP/DAC at 35%. I think this is what we are possibly seeing. So this would give us a 40% improvement in survival at 6 months. However the much sicker population enrolled in SEAMLESS may have delayed the curve separation. Perhaps this is why we failed futility but the DSMB suggested the trial continue because of this separation. What we lost in the beginning of the curve, may be gained at the end of the curve.

    Sentiment: Hold

  • In an effort to leverage the low toxicity profile of the SAP/ DAC regimen, investigators wanted to include the sickest oldest patients. Unfortunately, this approach has distanced results too far from the lead in pilot data and caused uncertainty. However, the only thing that matters in the end is relevance to control. In retrospect it might have been more prudent to include a "90 day survival requirement" similar to DACO-016 to eliminate the weakest patients from SEAMLESS.

  • Reply to

    What has happened in SEAMLESS

    by lifetolive7 Dec 18, 2014 7:58 AM
    lifetolive7 lifetolive7 Dec 18, 2014 4:49 PM Flag

    IceMan, they did not say Success was unlikely. They are saying HR .725 is unlikely. Big difference.

    Sentiment: Strong Buy

  • Clearly, a sicker population has been selected out by dropping the "12 week life expectancy requirement of DACO-016". It is also obvious that SEAMLESS is a sicker population than the Pilot Lead In ( which I am not happy about). I also believe the weak geographic trends of the US are in play. Since European data is not mature at this point, what we are primarily observing here are US results. Since we are dealing with a sicker population, I believe the spread between the arms has narrowed at the front end of the curve due to higher early mortality risk. As the curve progresses and more SAP// DAC cycles are administered relative to DAC cycles, the curves should separate and favor SAP/DAC . In Addition as Western European data matures, we will see more advantage to the SAP/DAC arm. We most like will not achieve HR.725, but it might be enough for approval (particularly the EU).

  • Reply to

    FROM DAY ONE CYCC SEEMS A HECK OF A SCAM!

    by jagan1961 Dec 17, 2014 1:05 PM
    lifetolive7 lifetolive7 Dec 17, 2014 1:35 PM Flag

    Ice, Daichi only had the "composition of matter patent". The price was pretty " reasonable and customary".

    Sentiment: Strong Buy

  • Forty-six patients were treated with alternating cycles of sapacitabine and decitabine, which is the treatment regimen in the experimental arm of SEAMLESS. Median age is 77 years (range 70-90). Thirty-three patients (72%) are 75 years or older. Median overall survival is 238 days, or approximately 8 months. The number of patients still alive at 3 months was 38 (83%), at 6 months 30 (65%), at 12 months 16 (35%) and at 18 months 12 (26%). Sixteen patients (35%) survived 1 year or longer. Among 33 patients who are 75 years or older, median overall survival is 263 days, or approximately 9 months, and 1-year survival is 36%. Nineteen patients (41%) responded with 10 complete responses (CRs), 4 partial responses (PRs) and 5 major hematological improvements (HIs). Median time to response is 2 cycles, i.e., one cycle of decitabine and one cycle of sapacitabine (range 1-10). Twenty-seven patients (59%) received 5 or more cycles of treatment. Two dose-limiting toxicities (DLT) were observed (lung infection/sepsis, typhlitis). Thirty-day mortality from all causes was 4%. Sixty-day mortality from all causes was 13% with one death from typhlitis considered to be possibly related to decitabine by investigator assessment. The sequential combination of decitabine and sapacitabine is safe and active. 65% were living at 6 months. This equates to 35% pooled deaths at 6 months What is going on?

    Sentiment: Strong Buy

  • lifetolive7 lifetolive7 Dec 17, 2014 5:35 AM Flag

    Iceman, Because much of the European data hasn't matured yet, most of the geographical variance has yet to be observed yet.

    Sentiment: Strong Buy

  • lifetolive7 lifetolive7 Dec 17, 2014 2:54 AM Flag

    Jathman, I criticized management on how the $3.00 offering was handled. Other than that. I was pretty happy with management's handling of clinical development. I respect them, however I am concerned about the pilot /lead in numbers not holding up to my expectations in the main trial. I think all my assumptions about the weak DAC control arm in the US are holding up. That being said, Europe (that will be more visible in the back end of the trial) should add nominally and comparatively to SAP/DAC MOS for reasons previously discussed. We should also prevail at the end of the curve. So I do believe SEAMLESS results will improve comparatively and nominally as the study progresses. That could play well with regulators.

CYCC
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