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Aeterna Zentaris Inc. Message Board

dcaf7 127 posts  |  Last Activity: 3 hours ago Member since: Apr 24, 2010
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  • Reply to

    AZ bought 2 biotech firms last year

    by nptimothy May 2, 2016 11:38 AM

    May be MEK inhibition in cell lines showed dismal responses but MEK inhibition with selumetinib in KRAS mutation-positive patients demonstrated 37% response rate (vs 0%) and prolonged PFS. Perhaps inhibition of both EGFR and MEK is a better strategy and will be explored in future but Phase 2 data indicate that inhibition of MEK only could be beneficial for patients.

  • Reply to

    AZ bought 2 biotech firms last year

    by nptimothy May 2, 2016 11:38 AM

    It has a good rationale. Trial's population is KRAS mutation-positive patients. How can you say "No "driver" mutations in the MAPK pathway"? What do you know?

  • Reply to

    ARRY at ASCO 2016

    by dcaf7 Apr 20, 2016 3:11 PM

    One more abstract
    Abstract 3544
    Phase 2 results: encorafenib (ENCO) and cetuximab (CETUX) with or without alpelisib (ALP) in patients with advanced BRAF-mutant colorectal cancer (BRAFm CRC).

  • He is correct. PFS in a single arm study cannot be used for any approval, including accelerated approval. Marqibo, Folotyn and Belinostat were all approved based on response rates. When you see a response, you know that it is a drug's effect. When you see a PFS curve with no control, what do you know? Placebo will also produce a curve.

  • dcaf7 dcaf7 May 2, 2016 2:46 PM Flag

    I would pay attention to what is going on with Neratinib. Compare titles for Poziotinob and Neratinib trials: "Poziotinib in Patients With HER2+ Recurrent Stage IV BC Who Have Received at Least 2 Prior HER2-directed Regimens" and "A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting". Same patient population and Puma runs a 600-patient Phase 3 study with PFS and OS as primary endpoints. I don't see how Spectrum is able to negotiate accelerated approval, especially, if the results of Neratinib trial are positive.

  • dcaf7 dcaf7 May 2, 2016 10:22 AM Flag

    ASH is American Society of Hematology. Why should they accept any abstract on breast cancer? And I don't understand why everybody is so excited about Raj's excitement. He is a specialist in hematologic oncology and does not have any experience in breast cancer and HER inhibitors. We need to hear about how exciting is a new Korean data from more knowledgeable person.‎

  • Immunotherapy Puts 93 Percent of Advanced Leukemia Patients in Remission
    Friday, 29 Apr 2016 12:20 PM

    An astounding 93 percent of patients with advanced leukemia that was resistant to multiple other forms of therapy went into remission after their T-cells were genetically engineered to fight their cancers.

    Researchers at Fred Hutchinson Cancer Research Center worked with the University of Washington Cancer Consortium to enroll patients with B-cell acute lymphoblastic leukemia. All of the patients had advanced disease that had relapsed and were immune to other therapies.

    The patients received genetically engineered versions of their own T-cells — disease-fighting immune cells — with a synthetic receptor molecule called a CAR (chimeric antigen receptor) that allows T-cells to recognize and kill cancer cells that carry a specific marker called CD19.

    T-cells were extracted from patients, and a specialized virus delivered the DNA instructions for making the CAR into the cells. Then, the cells were multiplied to the billions in the lab.

    After chemotherapy, the reengineered cells were infused back into the patients they came from about two weeks after they were first extracted.

    A few weeks after the infusion, highly sensitive tests could find no trace of cancer in the bone marrow of 27 of 29 patients. CAR T-cells eliminated cancers anywhere in the body they appeared.

    wwwDOTnewsmaxDOTcom/Health/Health-News/immunotherapy-leukemia-patients-remission/2016/04/29/id/726461/

    Great results, do not bode well for Marqibo.

  • Reply to

    The Fool on the hill is back

    by wilderguide Apr 27, 2016 5:41 PM
    dcaf7 dcaf7 Apr 28, 2016 9:21 AM Flag

    Read the comment from Barry H Kaplan to this article. It is an oncologist view on Cobi, Cabo and Opdivo. He said that "Opdivo's benefits have been outrageously overstated".

  • $16.7M, 10% higher than in 1stQ15

  • It was $7.6 on Aug 28, 2015 but other closing prices were lower.

  • Reply to

    Apaziquone trial update

    by dcaf7 Apr 21, 2016 10:15 AM
    dcaf7 dcaf7 Apr 22, 2016 3:11 PM Flag

    I think that the logic for the second instillation was following: although the difference between placebo and Apaz groups after 90 min was not significant, it was in favor of Apaz. You may need more patients to reach lower p value. It is possible that Apaz works on floating cells better, but it still works on attached cells. Therefore, you may expect an additive effect from two instillations.

  • Reply to

    Apaziquone trial update

    by dcaf7 Apr 21, 2016 10:15 AM
    dcaf7 dcaf7 Apr 21, 2016 12:54 PM Flag

    My question was rhetorical.

  • Reply to

    Apaziquone trial update

    by dcaf7 Apr 21, 2016 10:15 AM
    dcaf7 dcaf7 Apr 21, 2016 11:51 AM Flag

    Do we know from whom?

  • Reply to

    Apaziquone trial update

    by dcaf7 Apr 21, 2016 10:15 AM
    dcaf7 dcaf7 Apr 21, 2016 11:27 AM Flag

    It could be an error. I don't want to think about other possibilities.

  • Reply to

    ARRY at ASCO 2016

    by dcaf7 Apr 20, 2016 3:11 PM
    dcaf7 dcaf7 Apr 21, 2016 10:53 AM Flag

    Two more abstracts
    Abstract 2544
    A phase I study of MEK162 and FOLFOX in chemotherapy-resistant metastatic colorectal cancer.
    Abstract TPS2607
    SELECT-4: Phase I dose escalation trial of selumetinib (AZD6244, ARRY-142886) in combination with durvalumab (MEDI4736) in patients with advanced solid tumors.

  • Only one recruiting site is listed instead of 12 shown in the previous update. Also, they have a new contact person.

  • Abstract 9500
    Results of NEMO: A phase III trial of binimetinib (BINI) vs dacarbazine (DTIC) in NRAS-mutant cutaneous melanoma.
    Abstract TPS2609
    A Phase I/Ib study of MEK162 (binimetinib), a MEK inhibitor, in combination with carboplatin and pemetrexed in patients with non-squamous NSCLC.
    Abstract TPS2596
    Phase II trial of the MEK1/2 inhibitor selumetinib (AZD6244) in adults with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PNs).
    Abstract TPS10586
    Phase II Study of the MEK 1/2 inhibitor selumetinib (AZD6244, ARRY-142886) in children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN).
    Abstract 513
    Efficacy results of a phase 1b study of ont-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases.
    Abstract 5017
    Randomized phase II study of AKT blockade with ipatasertib (GDC-0068) and abiraterone (Abi) vs. abi alone in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel chemotherapy (A. MARTIN Study).
    Abstract TPS1105
    FAIRLANE: A phase II randomized, double-blind, study of the Akt inhibitor ipatasertib (GDC-0068) in combination with paclitaxel as neoadjuvant treatment for early stage triple-negative breast cancer.
    Abstract TPS2599
    A Phase II Basket Study of the Oral TRK Inhibitor LOXO 101 in Adult Subjects with NTRK Fusion-Positive Tumors.
    Abstract TPS10583
    A pediatric phase 1 study of LOXO-101, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family.

  • Reply to

    Folotyn at ASCO 2016

    by dcaf7 Apr 20, 2016 1:46 PM
    dcaf7 dcaf7 Apr 20, 2016 2:46 PM Flag

    I am not sure what Spectrum needs to do with Folotyn/leucovorin combo. I don't think they keep in mind a phase 3 trial. Most likely, they want to publish data and hope that doctors will use leucovorin off-label.

  • Reply to

    Folotyn at ASCO 2016

    by dcaf7 Apr 20, 2016 1:46 PM
    dcaf7 dcaf7 Apr 20, 2016 1:59 PM Flag

    Two things are important:
    1. Seems like leucovorin reduces incidence of mucositis caused by Folotyn. Otherwise why to present?
    2. I did not know that Folotyn is used against CTCL. Is it off-label?

  • Abstract 2552
    Development of novel backbones for the treatment of peripheral T-cell lymphoma (PTCL): The pralatrexate/ romidepsin doublet.
    Poster Board: #252
    Jennifer Effie Amengual, MD - Presenter
    Columbia University Medical Center

    Abstract 7558
    Impact of leucovorin on mucositis and skin reactions in pts with peripheral t-cell Lymphoma (PTCL) and cutaneous t-cell lymphoma (CTCL) treated with pralatrexate.
    Poster Board: #114
    Francine M. Foss, MD - Presenter
    Yale Cancer Center

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