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Cyclacel Pharmaceuticals, Inc. (CYCC) Message Board

lifetolive7 512 posts  |  Last Activity: 45 minutes ago Member since: Dec 6, 2010
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  • 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).

  • lifetolive7 lifetolive7 19 hours ago 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.

  • I want everybody to know that I spent a tremendous amount of time and energy studying this investment but I have obviously been blindsided by this outcome of futility. If there is an explanation, I haven't found it. The only thing that comes to mind is that the 46 patients of the lead in / Pilot are not accurately representative of what we are enrolling in SEAMLESS. I want people to know that I have a very substantial investment involved here. The company has discussed their plans going forward and discussed the prospects from here. Is there still a chance for SEAMLESS approval? Yes, particularly in the EU. RMDS also has significant potential. However, there is no doubt this was a disappointment and puts us in a position of seeking approval outside the provisions of the SPA. There are many here that will gloat and make comments of hatred here because that's who they are. I made a commitment not to post here if we failed futility, so I am keeping my word.

    Sentiment: Strong Buy

  • A remarkable and unprecedented early separation at the beginning of the curve. At 60 days I see 13% versus 26% mortality rate. At the middle of the curve (MOS), an unprecedented 10 + months survival in the SAP/DAC arm of this challenging elderly population . The DAC control should come in under 6 months. At the end of the curve, an unprecedented 18% survival at 30 months while all the patients in the DAC control will have died.

    Sentiment: Strong Buy

  • Reply to

    could company PR 212 events?

    by valueinvestor411 Dec 10, 2014 10:46 PM
    lifetolive7 lifetolive7 Dec 12, 2014 6:16 AM Flag

    Value, I believe the Valor 60+ pre-planned subgroup (HR=.75) is what the DSMB predicated their decision on to continue Valor at interim analysis. It appears the reason they increased the size of the trial was to give that subset adequate power at top line. The slightly deficient HR of .025 doesn't bother me so much, however I don't like the considerably higher censor rate in the active arm over control (19.9% vs 10.7 %). To me this suggests a higher drop out rate due to the higher toxicities of the VOS/ CYT regimen versus CYT/PLA.

    Sentiment: Strong Buy

  • Reply to

    Hang on to that pipe dream l2l

    by invest_a_mint Dec 11, 2014 11:13 PM
    lifetolive7 lifetolive7 Dec 12, 2014 5:05 AM Flag

    Remember Jk, if we pass Futilty you AND your alias' leave.

    Sentiment: Strong Buy

  • Reply to

    could company PR 212 events?

    by valueinvestor411 Dec 10, 2014 10:46 PM
    lifetolive7 lifetolive7 Dec 11, 2014 4:49 PM Flag

    Value you are WAAAAAAY off.

    Sentiment: Strong Buy

  • Reply to

    L2L has been blowing smoke up

    by jk4763 Dec 11, 2014 9:23 AM
    lifetolive7 lifetolive7 Dec 11, 2014 9:28 AM Flag

    Jk, futility is probably coming within weeks. We are all looking forward to banishment from this board.

    Sentiment: Strong Buy

  • Reply to

    DACO-016 criteria

    by lifetolive7 Dec 11, 2014 5:14 AM
    lifetolive7 lifetolive7 Dec 11, 2014 6:39 AM Flag

    We have some tremendous, quality people that read this board. I had the amazing complement of meeting one of them this past Sunday, the gentleman is a kind, honest, intelligent and sincere businessman that flew across the country just to spend Sunday with me. Our entire day was completely spent discussing Cyclacel. I will leave him un- named.

    Sentiment: Strong Buy

  • Reply to

    DACO-016 criteria

    by lifetolive7 Dec 11, 2014 5:14 AM
    lifetolive7 lifetolive7 Dec 11, 2014 6:32 AM Flag

    Thanks Michael, a couple of weeks ago some poster asked me "what are you, some type of do gooder"?. He struck me as a #$%$ off short. I have a lot of friends and associates in this stock. I have a personal sense of responsibility to keep things real here. Everything is pointing our way in SEAMLESS. For once in this world, I want the good hard working honest people to win.

    Sentiment: Strong Buy

  • lifetolive7 by lifetolive7 Dec 11, 2014 5:49 AM Flag

    Weak DAC control.

    Sentiment: Strong Buy

  • Reply to

    DACO-016 criteria

    by lifetolive7 Dec 11, 2014 5:14 AM
    lifetolive7 lifetolive7 Dec 11, 2014 5:37 AM Flag

    I believe the "12 week life expectancy requirement" had a definite effect of raising the quality of patients in 016. It basically shifts the whole DAC curve to the right in 016 and particularly lowered the 60 day mortality rate. It places investigators in a position of "Patient cherry puckers". Since "12 week expected survival" is largely a subjective judgement, this introduced a variable into the 016 study that destroyed P value.

    Sentiment: Strong Buy

  • lifetolive7 by lifetolive7 Dec 11, 2014 5:16 AM Flag

    Inclusion Criteria:

    Newly diagnosed AML based on WHO classification
    Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
    ECOG performance status 0-2
    Adequate renal function
    Adequate liver function
    Able to swallow capsules
    Agree to practice effective contraception
    Ability to understand and willingness to sign the informed consent form
    Exclusion Criteria:

    AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
    Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding MDS or MPD
    Known or suspected central nervous system (CNS) involvement by leukemia
    Uncontrolled intercurrent illness
    Known hypersensitivity to decitabine
    Known to be HIV-positive

    Sentiment: Strong Buy

  • lifetolive7 by lifetolive7 Dec 11, 2014 5:14 AM Flag

    Criteria
    Inclusion Criteria:

    Must have diagnosed acute myeloid leukemia.
    Must have a life expectancy of at least 12 weeks.
    Must sign informed consent.
    Exclusion Criteria:

    Must not have acute promyelocytic leukemia (M3 classification)
    Must not have any other active systemic malignancies.
    Must not have inaspirable bone marrow.
    Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
    Must not have chronic respiratory disease that requires continuous oxygen use.
    Must not have received any experimental drug within 4 weeks before randomization.
    Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
    Must not have known HIV.

    Sentiment: Strong Buy

  • Reply to

    could company PR 212 events?

    by valueinvestor411 Dec 10, 2014 10:46 PM
    lifetolive7 lifetolive7 Dec 11, 2014 4:34 AM Flag

    FWIW, I believe we passed 212 events already and are now waiting for the analysis.

    Sentiment: Strong Buy

  • Reply to

    Winston you said you were contacting IR

    by jathman Dec 10, 2014 8:46 PM
    lifetolive7 lifetolive7 Dec 11, 2014 4:31 AM Flag

    It's not a big concern for me , but I do have it on a list along with my more important clinical questions.

    Sentiment: Strong Buy

  • Your garbage isn't fooling anybody. The longs here see success that awaits us dead ahead. Go pound sand.

    Sentiment: Strong Buy

CYCC
0.74+0.06(+8.81%)Dec 17 4:00 PMEST

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