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Cyclacel Pharmaceuticals, Inc. (CYCC) Message Board

  • valueinvestor411 valueinvestor411 Sep 28, 2013 4:28 PM Flag

    CNN article mentions Ovarian cancer, brca mutation and md anderson

    Mentions brca and MD anderson; I'm sure they have sapa/seli on the shelves there too.

    lifetolive7: Seems like sapa or sapa+seli should be considered in addition to the drug mentioned?


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    • Value, just as a means of comparison, the phase 1 SAP/SEL in vivo study by Dr.Shapiro yielded the following results as of 4/13...... Of 16 patients in a heavily pre-treated population of patients with "advanced solid tumors" (3 month life expectancy) there were SO FAR 4 partial responses, and 8 cases of stable disease(activity in 75% of the patients). The number of cycles received ranged from 4 cycles up to 29 cycles. The patient with 29 cycles has almost achieved complete tumor shrinkage. We eagerly await updates on this trial as the patients undergo more cycles. I believe the SAP/SEL combination will become a powerful tool in treating multiple forms of cancer.

      Sentiment: Strong Buy

      • 2 Replies to lifetolive7
      • lifetolive: thanks for extremely detailed response. And I think you illuminated the point I was going for. The focus of this cancer patient is on one therapy in phase 1 when there is another therapy that has stood a better test of time in terms of its safety profile and at least equivalent in terms of its efficacy against this particular mutation in this particular indication.

        Especially in light of the fact she's receiving care at MD Anderson, who we believe to be a big sapa advocate.

        Why should this patient not include Cyclacel and the seli / sapa combo in her attempts to gain access to chance at survival.

        In addition to the clinical evidence, cycc just issued a PR on preclinical ovarian cancer cells potential efficacy against ovarian cancer cells.



        Sentiment: Hold

      • I want to correct an error, Of the BRCA1 and BRCA2 population (16 patients in Shapiro's study), there were SO FAR 4 partial responses, 3 stable disease, and 4 progressive disease. So, 44% of this extremely sick, heavily pre-treated population, were either stable or getting an ongoing partial response from SAP/SEL therapy. This patient population is significantly more advanced more pre-treated than the referenced PARP study population.

        Sentiment: Strong Buy

    • Value, on the CNN article. As I have discussed before, PARP inhibitors are a BRCA1 and BRCA2 targeted attempt to disable the HR pathway by targeting PARP1. In addition, PARP2 may be targeted which can cause cytotoxic conditions for cancer cells. As you know, Selicilib works by another mechanism, specifically by CDK inhibition and acts on both the HR pathway and the NHEJ pathway. I like our approach better for a few reasons. At first glance, it looks like their drug has more toxicity so I don't think people will want to stay on it very long. The PARP inhibitors work better if used with a DNA damaging agent (such as Sapacitabine). If you already have significant toxicity with the PARP inhibitior, the DNA damaging agent combination will be even more challenging from a toxicity stand point. In addition, from the very limited data that has come through, the response rates don't look overwhelmingly impressive. It is however another tool in the bag for this multifactorial disease. Dr.Shapiro's (Dana Farber) work on SAP/SEL in advanced solid tumors, yielded some really impressive data. However, It should be noted that was a combination and not a single agent study. The important point is, the SAP/SEL COMBINATION is highly effective and highly tolerable. As a DNA damaging agent , Sapacitabine appears to be second to none in HR deficient populations. In the article below, note they had about activity in 25% ( 8 / 31) of the HRD selected ovarian cancer population in Vivo. In an HRD unselected population, Sapaciabine (as a single agent) was active in 75% of the ovarian cell lines in Vitro. Although one obviously cannot compare in vitro against in vivo results, it is interesting that SAP as a single agent was able to achieve almost double the activity of Cisplatin in vitro.

      Sentiment: Strong Buy

      • 1 Reply to lifetolive7
      • A dual-action PARP inhibitor has shown sufficient clinical activity to continue its investigation in women with recurrent BRCA-mutant ovarian cancer, preliminary results from an ongoing phase II trial showed.

        Eight of 31 evaluable patients had partial responses to veliparib, which inhibits both PARP-1 and PARP-2. An additional 20 patients have not reached the follow-up period necessary to assess response, Robert Coleman, MD, reported at the 2013 Annual Meeting of the Society of Gynecologic Oncology.

        Most of the 51 patients enrolled had minimal hematologic toxicity, whereas a majority had one or more types of nonhematologic adverse events, particularly nausea.

        “Although early for overall assessment, veliparib, at this dose and schedule, is tolerable in this population,” said Coleman, professor of Gynecologic Oncology at the University of Texas MD Anderson Cancer Center in Houston. “The clinical activity in this phase II trial has met the minimal efficacy benchmark to be considered ‘of clinical interest.’”

        “The overall response rate is unknown at this point, as too few patients have been on treatment long enough to assess response.”

        Follow-up duration is insufficient to assess secondary outcomes, which include progression-free survival (PFS) and overall survival, he added.

        Veliparib is one of almost a dozen PARP inhibitors in various stages of clinical evaluation. The agents are being tested in several types of solid tumors, including primary, recurrent, and platinum-sensitive/resistant ovarian cancer.

        Veliparib is an oral drug that inhibits both isoforms of the targeted enzyme. Inhibition of PARP-1 disrupts the DNA-repair process that cancer cells require for continued development and progression. Inhibition of PARP-2 induces a toxic intracellular environment that enhances cell killing.

        Sentiment: Strong Buy

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