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Cytokinetics, Incorporated Message Board

too_much_sunshine 10 posts  |  Last Activity: Dec 22, 2014 11:40 PM Member since: Apr 14, 2007
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  • too_much_sunshine too_much_sunshine Dec 22, 2014 11:40 PM Flag

    You're welcome, dr_lucid. I'm happy to chime in.

    As far as a partner, it is quite likely there was already interest in CCX-140. Now that randomized Phase 2 data is available, the value proposition is more clear. Thus I would expect partnership talks to accelerate. Even so, strategic discussions can be complicated, so it may be more than a couple of months before a deal is finalized. We’ll just have to wait and see.

    For a strategic transaction, the valuation is based on validation. There are two validations that have been provided by the CCX-140 results: the drug and the platform. Not only has CCX-140 been validated as a compelling drug candidate, but due to the continued progress with CCX-168, as well as the validation of Vircirnon in the Phase 3 "SHIELD-4 trial", I would argue that the Chemocentryx platform itself has been validated. A successful platform and a large pipeline make the company much more interesting than a single drug.

  • Reply to

    B/O TREMORS

    by koufax62 Dec 17, 2014 7:35 PM
    too_much_sunshine too_much_sunshine Dec 21, 2014 9:24 PM Flag

    I'm very interested in the details from the Prostate Cancer P2. It would be nice to see them at ASCO GU in February (if the data was available soon enough). The PFS increase was "highly statistically significant". Hopefully that trial provides a path to Phase 3 in PC, but with the trial being single agent versus placebo, I don't know. I still feel that the lung cancer Phase 3 data should be sufficient to pursue another Phase 3 in that indication, this time with the cMET high. It's really not that difficult; cMET is not just some biomarker, it's the target. So there is an obvious theoretical rationale as well as the strong empirical biomarker-based data from the previous Phase 3, both of which should be enough to go back and try again. Some movement in these areas could help put Arqule back on investors' radar. This may also solidify the value proposition for a potential acquirer.

  • too_much_sunshine too_much_sunshine Dec 21, 2014 2:11 PM Flag

    Addressing these points in order. (some of my arguments may hold more water than others):

    1. "No dose effect"- The kinetics of biological systems are non-linear. The 10mg did show a treatment effect, which suggests they were not randomly getting one dose to work. And as management alluded to in the CC, MCP-1 levels indicate that the 10mg dose may "contribute to a breakthrough effect".

    2. "acute effect in eGFR in first 12 week (bad or good?)" I don't know, except that it did not seem to cause any harm. As long as meaningful improvements are sustained I would think it's a non-issue.

    3. "UACR effect peaked at week 12"-Management pointed out that over the period of week 12 to week 52 the levels were comparable-no decline in treatment effect after 12 weeks. Halting progression would be the goal, so an anti-inflammatory mechanism should achieve it's part relatively quickly. But damage already done would not be remedied.

    4. "phase III need eGFR as primary endpoint"- It would seem so; points 2, 5 and 6 are relevant issues here.

    5. "no p value for annual slope of eGFR reduction (assume p not stat sig)"- The question is whether the improvements are clinically meaningful and whether they could be driven to significance by increasing the patient number (i.e. in Phase 3).

    6. "delta of eGFR is small (only 1 ml)"-as opposed to what? "1 ml" is a small number, but what matters is what is clinically meaningful. As stated to by lieinhart, a delta of 0.8ml was sufficient for Losartan approval.

    7. "high dropout rate 15% (initial 332, then protocol changed for 52 wk extension. 102 pt not eligible, so start n = 230. finished 196)"-Zheng makes an error here. His argument assumes no dropouts in the initial patients. The correct model would include "102 completed 12 weeks but not eligible, X number of patients dropped out, so start n = 230 MINUS X." From the "230 MINUS X" group more dropped out, giving 196 at 52 weeks. (Discussed on the CC starting at 29 min.)

  • too_much_sunshine too_much_sunshine Dec 19, 2014 8:58 AM Flag

    Two comments on the lower performance status subgroup. First, a KPS score below 80 as a cutoff is not arbitrary; below 80 a patient can be described as debilitated, as opposed to functioning normally. Second, with around 90 patients per arm, "more than one third" would mean 31 or more (not considering any imbalance) in each arm that would be included in the analysis for risk of death. That number of patients is actually a good number for a phase 2, as opposed to being a subgroup of say, 5 or 10 patients. So they use a legitimate KPS score cutoff which also provides a respectable number of patients for the subgroup analysis, indicating some value to that analysis as an assessment of the drug's potential.

  • too_much_sunshine too_much_sunshine Dec 18, 2014 8:22 PM Flag

    I don't really like price weakness approaching a milestone. I don't like Friday data releases either (not that we'll necessarily get one with CNAT). But take a look at CCXI. Very often there's no one who "knows something" and sometimes news comes out on a Friday because that's the next opportunity.

  • Reply to

    28% of float is short

    by dr_lucid Dec 12, 2014 8:02 AM
    too_much_sunshine too_much_sunshine Dec 12, 2014 8:22 AM Flag

    I agree, lucid. Better result than I hoped for, I'll admit. It's been such a long slog. I've thought for years that the platform and approach were elegant, but the stock performance has been abysmal. It's really nice to finally see this, to say the least.

    Or, put another way, and in answer to Motley Fool (I think) from 2013: "Platform problem, my #$%$"

  • too_much_sunshine by too_much_sunshine Dec 11, 2014 4:50 PM Flag

    Results will be discussed on a CC at 8:30AM.

  • too_much_sunshine by too_much_sunshine Dec 2, 2014 4:06 PM Flag

    Well, there it is...

  • Reply to

    looks like they took stops hit $1.98 wowowowow

    by apfappa Nov 6, 2014 10:16 AM
    too_much_sunshine too_much_sunshine Nov 6, 2014 10:21 AM Flag

    Indeed. People throw around the term "bear raid", but I think it's fair to say that was at least a mild one.

  • too_much_sunshine by too_much_sunshine Nov 6, 2014 10:09 AM Flag

    Wow-surprising no volatility halt with this. Though, admittedly, I'm not certain of the criteria for that.

CYTK
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