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Sucampo Pharmaceuticals, Inc. Message Board

dcaf7 14 posts  |  Last Activity: Jul 21, 2016 4:39 PM Member since: Apr 24, 2010
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  • Who is going to use this MB?

  • dcaf7 dcaf7 Jul 13, 2016 8:47 AM Flag

    "why didn’t they wait for the Korean P2 to finish in Dec and use those results as the basis of a P3"
    They need to have confirmatory data with non-Korean patients. I wouldn't start any phase 3 trial in US based on the results of phase 2 trial conducted in Korea.

  • dcaf7 dcaf7 Jul 12, 2016 12:11 PM Flag

    An unmet medical need simply means providing a therapy when none exists or providing a new therapy that may be superior to or less toxic than an existing one. For AA, Spectrum needs to convince FDA that Poziotinib is superior to Neratinib or safer. BTW, Lapatinib, another HER inhibitor, is already approved for metastatic BC and in current Ph3 trial Puma hopes to demonstrate that Neratinib plus Capecitabine is superior to Lapatinib plus Capecitabine . What kind of data Spectrum should bring to FDA to convince them to grant AA? Why Puma did not get AA for Neratinib from FDA?

  • Reply to

    Lymphomation for Zevalin

    by kyelion Apr 18, 2016 2:54 AM
    dcaf7 dcaf7 Jul 12, 2016 10:21 AM Flag

    Well said arguments there.

  • Reply to

    Professional views

    by bioblitz1 Jul 11, 2016 9:36 AM
    dcaf7 dcaf7 Jul 12, 2016 9:09 AM Flag

    "Powering the drug for superiority" is not what company did intentionally. Current study run by Spectrum is a non-inferiority trial and it requires many patients. It happens that the number of patients in non-inferiority trial allows them to make a superiority analysis. Many other non-inferiority trials are/were powered for superiority. It is not a special design of the trial from Spectrum although from what Raj/you said it sounds like something encouraging.

  • Juno Therapeutics, Inc. (JUNO) today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the “ROCKET” trial. The clinical hold was initiated after two patient deaths last week, which followed the recent addition of fludarabine to the pre-conditioning regimen.

  • Reply to

    O.K. So lets Assume the FDA will Approve

    by thirtysixred2001 Jul 5, 2016 11:57 AM
    dcaf7 dcaf7 Jul 5, 2016 6:38 PM Flag

    ARRY sees N-Ras metastatic melanoma market as $60 million in US and $100 million in Europe. In US, it is about 2000 patients a year, with about three-month duration of treatment.

  • Pralatrexate in Combination with Bortezomib for Relapsed or Refractory Peripheral T Cell Lymphoma in 5 Elderly Patients.
    Peripheral T cell lymphoma (PTCL) is a heterogeneous group of aggressive lymphomas with poor prognosis. Elderly (age ≥ 65years) patients generally have impaired bone marrow function, altered drug metabolism, comorbidities, and poor functional status. Thus, treatment of elderly patients with relapsed or refractory PTCL remains a challenge for clinicians. A recent study disclosed that pralatrexate has a synergistic effect in combination with bortezomib. Weekly pralatrexate and bortezomib were administered intravenously for 3 weeks in a 4-week cycle. Of 5 patients, one achieved complete response after 4 cycles which has lasted 12 months until now. Another patient attained partial response after 2 cycles. Only 1 patient experienced grade 3 thrombocytopenia and neutropenia. Two patients suffered from grade 3 mucositis. Combination therapy with pralatrexate and bortezomib may be used as a salvage therapy for relapsed or refractory PTCL in the elderly with a favorable safety profile.
    One CR and one PR out of five patients translates into 40% response rate. Good results.

  • Reply to

    XL-550

    by dcaf7 Jul 2, 2016 3:19 PM
    dcaf7 dcaf7 Jul 3, 2016 9:13 AM Flag

    EXEL should mention it in their presentations.

  • dcaf7 by dcaf7 Jul 2, 2016 3:19 PM Flag

    What is going on with this compound? Checked Clinicaltrials gov and found that CS-3150 (XL-550) is in 4 phase 3 trials.

  • dcaf7 dcaf7 Jul 2, 2016 9:11 AM Flag

    It was not a blinded study, patients had infusion of dacarbazine or pill of Binimetinib, obvious for everybody what arm are you in. Significant percentage of patients dropped out at a very start of study, mostly from dacarbazine arm, and switched to immunotherapy. Therefore, longer OS. FDA will consider it.

  • “Efficacy and Safety of Vincristine Sulfate Liposome Injection in the Treatment of Adult Acute Lymphocytic Leukemia” published in The Oncologist.
    It is a nice review with three individual patient cases. There is an interesting discussion on how the patient population for Marqibo will look like when CAR-T therapy is available. Marqibo will be used for:
    - patients with T-cell lineage ALL. CAR-T works only for B-cell lineage ALL
    - keeping the tumor from progressing during the time needed for CAR-T cells preparation in the laboratory
    - palliative treatment

  • Reply to

    News !

    by cancerspeculator Jun 29, 2016 2:28 PM
    dcaf7 dcaf7 Jun 29, 2016 5:39 PM Flag

    I am not losing my hope. Waiting for results from selumetinib phase 3 trial in NSCLC and from bini+enco phase 3 trial in B-Raf melanoma.

  • Reply to

    News !

    by cancerspeculator Jun 29, 2016 2:28 PM
    dcaf7 dcaf7 Jun 29, 2016 4:34 PM Flag

    "2 NDA FILING FIRST HALF OF THE YEAR". I know only about ONE NDA filing in 1H, it is for binimetinib in N-Ras melanoma. What is the second one?

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