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Sanofi Message Board

scistats 232 posts  |  Last Activity: Jul 2, 2015 3:28 AM Member since: Apr 5, 2009
  • Reply to

    Athersys Mentioned in Maxim Report Today

    by wall_street_titan Jul 1, 2015 3:43 PM
    scistats scistats Jul 2, 2015 3:28 AM Flag

    Nice find!
    But, yes, it is a mistake.
    It should be 0-24 hours.

  • scistats scistats Jun 30, 2015 12:00 AM Flag

    Chugai is an oncology company. They have now dropped Athersys for stroke like a hot potato. Get over it.

    Athersys now needs to think strategically which DOES NOT mean going it alone with a second phase 2. This would be pure stupidity.

    Gil can learn a lesson from Geron who had Mayo Clinic run their imetelstat trial first as an IST that was then picked up by Janssen when Mayo proved authoritative efficacy.

    This is how you do it!

    Let Erlanger run the damn stroke trial as an IST until they nail down the early infusion efficacy. This would be both cost effective and definitive. Then, a big dog in cardiovascular, like Abbott, will launch a world-wide phase 2 with hundreds of patients to get orphan status and early market approval.

    Athersys has no money, and the Chugai stroke deal is an absolute stinking pile of #$%$. They are not interested, so get over it. Chugai is not taking this forward. As I said, they are a freaking oncology company that is just going to give Multistem a bad name with their short sighted all or nothing hege bet they just took. They are not the least bit serious about seeing this through.

    What Chugai can do, if they have the sense, is use Multistem for oncology per the systematic review I have posted following Celgene's lead.

  • scistats scistats Jun 28, 2015 2:43 PM Flag

    If Athersys had maintained infusion at 24-36 hours following ischemic stroke, "we'd still be waiting for results".

    What does this say about enrolling the next trial, even with cells available 24/7 and focuing on the 24-36 hour group? Will we still be waiting?

    The problem:
    Erlanger, and other major stroke centers, have rapid response telestroke and very efficient clot removal teams. With this strategy in place, they are eliminating the need for Multistem BASED ON THE STUDY STROKE SCALE CRITERIA because more and more patients are recovering within 24 hours and fewer patients are available that have exceeded the 24 hour mark.

    Strategy:
    Multistem has to be given to ALL patients no later than 24 hours, and the enrollment size has to be larger to distinguish that the subgroup that normally does not recover with standard of care alone recovers with Multistem. Or that Multistem enhances recovery of the majority of all patients beyond standard of care.

    Multistem is an insurance policy for stroke victims:
    Then, we have to get dose costs down to below 5 thousand USD to justify dosing everyone who has a stroke.

    Doing this may be justifiable considering the cost burden of taking care of one incapaciated person runs into the millions. We need economies of scale here, and this means everyone gets a little Multistem to make it work. Think of Multistem as an insurance policy that cannot survive if standard of care recovery pateints do not also enroll. If Japan gets this and all patients undertand they may be the ones who need it, Athersys might just pull this thing off. But, it is going to take a collective effort on the part of Japan. In this sense, Japan is the best place in the world to achieve this.

  • scistats scistats Jun 28, 2015 3:13 AM Flag

    There are two sides to Athersys management, greed and pride. Greed pays inflated salaries and bonuses while pride actually wants to make a medical contribution.

    Perhaps is was greed that resulted in a change in the protocol to speed things up ? The extension to 48 was the kiss of death, but even 36 hours is too long.

    As far as needing to increase enrollment numbers for stroke, I already gave references about stroke variability and samples size calculations. Because of this, a small trial, even dosing at less than or equal to 24 hours, could eat ATHX's lunch. With stroke, you either go big or go home. I hope Chugai gets this and understands that 36 hours is too long.

    Lonza will take care of cell expansion, and the MAPC advantage will make it rise to the top for oncology applications. Apceth's dose was not high enough, as seen in their ASCO abstract. I think they will need Athersys' Multistem in addition to tweeking their system.

    Biggest mistake Athersys ever made...
    Before (Updated 2011_09_16)
    single infusion 24-36 hours following ischemic stroke

    After (Updated 2011_10_24)
    single infusion 1-2 days (24-48 hours) following ischemic stroke

  • SCALING UP AND MANUFACTURING CHALLENGES

    10:30 AM
    Overcoming Comparability and Scale-Up Challenges in Cell Therapy Production

    Robert DeansRobert Deans, Ph.D., EVP, Regenerative Medicine, Athersys, Inc.

    Advancing cell therapeutics to commercialization requires adapting early pilot scale clinical manufacturing to a scale meeting commercial expectations. Improvements and scaling cell processing can involve radical shifts in bioreactor format, often moving from 2D planar culturing to microcarrier based bioreactor formats. A case study will be presented for comparability analysis involving MultiStem®, an adherent adult stem cell product, in commercialization for cardiovascular and CNS indications.

  • Mesenchymal stem cells as vectors for lung cancer therapy.
    Respiration. 2013;85(6):443-51
    Lungs for Living Research Centre, University College London, London, UK

  • If Chugai and Athersys really are ignoring oncology...we have a major problem.

  • Athersys and Chugai getting beat!!!!!!!

    We also expect to initiate a Phase I/II trial for the allogeneic off-the-shelf version of Agenmestencel-T (Agenmestencel-L) in Q4 2015

  • Therapy loaded Multistem: Off-the-shelf for targeting tumors or metastases

    Yes Chugai and Athersys are playing catch-up, but Multistem has advantages.

  • scistats scistats Jun 25, 2015 12:04 AM Flag

    Multistem will be off-the-shelf engineered for targeting tumors or metastases at economies of scale that bring quality patient treatment at rock bottom prices.

  • CHUGAI AND ATHERSYS' MULTISTEM ARE NEXT!!!

    *****************************************************************************************************************
    *****************************************************************************************************************
    apceth begins Agenmestencel-T Phase II clinical trial in gastrointestinal cancer patients
    Published on March 27, 2015

    Successfully Completed Phase I Clinical Study and Regulatory Approval Enable World’s First Genetically-Engineered Cell Therapy to Enter Phase II

    apceth, a global leader in engineered cell therapies, today announced the successful completion of the Phase I and initiation of the Phase II part of its ongoing monocentric Phase I/II clinical trial TREAT-ME 1 with the engineered cell therapeutic product Agenmestencel-T, at the Klinikum Grosshadern in Munich. To the company’s knowledge, this is the first time that a genetically engineered Mesenchymal Stem Cell (MSC) treatment has successfully completed a Phase I clinical trial and been approved to initiate a Phase II trial. The first patient in the Phase II trial has already been treated.

    apceth’s proprietary Agenmestencel-T next-generation MSC therapy is based on cells harvested from the patient's own (autologous) bone marrow, which are processed, genetically modified, and re-infused into the patient. The cells specifically target tumors or metastases, and, upon reaching the target tissue, the cytotoxic gene product is selectively activated, increasing local efficacy with reduced systemic toxicity.
    *****************************************************************************************************************
    *****************************************************************************************************************

  • scistats scistats Jun 24, 2015 3:05 PM Flag

    I think a lot of people, like dr_sumitchawla, who used to follow ATHX felt the stroke analysis was a stretch. I think there is something there myself, but Gil needs to dial back to no later than 24hr infusion and the next trial has to have massive enrollment to statistically prove anything because of spontaneous recovery and clot removal advancements that keep improving daily. So, maybe another stroke trial might happen, but Chugai seems to want to say, "it not you its me" for stroke. I think they want Multistem for cancer myself.

  • Reply to

    scistats are you becoming a basher

    by jmcleod_2000 Jun 24, 2015 10:11 AM
    scistats scistats Jun 24, 2015 2:57 PM Flag

    I am simply pointing out the facts and potential of cancer targeting and therapy using stem cells.
    In light of Chugai's wet dish rag response to the stroke data, I think they have more in mind for Multistem, which better aligns with what they do, oncology.

    In my opinion, this is a good thing, and if Chugai also continues the stroke program, even better. Spontaneous recovery and advances in clot removal, however, both muddy the water and show more affordable bang for buck, respectively.

    I think Athersys has the right partner but the wrong indication, but this equation is about to change.

  • scistats scistats Jun 24, 2015 2:46 PM Flag

    Celgene and Mesoblast are now close behind, pursuing this novel approach of using cancer seeking stem cells to deliver therapy. Chugai has seen the light...

  • "These studies demonstrate that not only are MSCs present in sites of prostate cancer where they may contribute to carcinogenesis, but these cells may also potentially be used to deliver cytotoxic or imaging agents for therapeutic and/or diagnostic purposes." Oncotarget. 2013 Jan; 4(1): 106–117

    Phase I proof of concept is currently recruiting to prove this out in humans.
    Principal Investigator: Samuel Denmeade, MD, Johns Hopkins University

    ClinicalTrials.gov Identifier: NCT01983709

  • JOHNS HOPKINS RECRUITING: HOMING MSCs TO PROSTATE CANCER
    ATHERSYS AND CHUGAI ARE NEXT!
    *********************************************************************************************************************
    *********************************************************************************************************************
    ClinicalTrials.gov Identifier - NCT01983709 (This study is currently recruiting participants.)

    The objective of this study is to determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate. This trial will provide the foundation for future studies aimed at ENGINEERING MSCs TO DELIVER A TOXIN TO SITES OF METASTATIC PROSTATE CANCER.
    *********************************************************************************************************************
    *********************************************************************************************************************

  • Reply to

    PREIMENENT STATISTICIAN COUNSELS INVESTORS

    by nervous_hospital Jun 23, 2015 7:39 PM
    scistats scistats Jun 23, 2015 7:44 PM Flag

    Celgene is doing the same thing with Mesoblast cells, so this is not novel or surprising.

  • Reply to

    PREIMENENT STATISTICIAN COUNSELS INVESTORS

    by nervous_hospital Jun 23, 2015 7:39 PM
    scistats scistats Jun 23, 2015 7:43 PM Flag

    Chugai's primary focus is oncology.
    What do you think is on their minds?

  • scistats scistats Jun 23, 2015 7:39 PM Flag

    Yags, I think that Chugai is suffering from being overextended into therapeutic antibodies. Their primary indication is cancer. I think they understand the advantages of an off-the-shelf MAPC or MSCs for therapeutic delivery at the site for tumors and, much more important, micrometastases.

    They see the competition around them at places like Takara.

    Gil made a visit, and they said, sure, we will go along with your stroke story, but we also have something else in mind. If you agree, we will pay you $10 million upfront with this understanding. Regardless of stroke, we want to also pursue oncology indications with your MAPC platform.

    Meanwhile, Celgene is doing the same thing with Mesoblast cells, so this is not novel or surprising.

    With all the spontaneous recoveries that muddy the waters of stroke beyond hope, Athersys is about to become an oncology company. I believe that Chugai does not buy the stroke story. During the conference call, they said it did not reach its goal of efficacy. We likely have to accept this.

    What Chugai does believe, and what others believe is MAPC/MSC cancer therapy delivery, and I think this is where we are going.

    Having said this, Gil and the rest of the Athersys team have no clue about oncology. So, I think management is in trouble. If Chugai progresses stroke, I will be very surprised. What I see is oncology regardless of another stroke trial.

SNY
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