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Zalicus AŞ Message Board

scistats 75 posts  |  Last Activity: Aug 9, 2015 1:54 PM Member since: Apr 5, 2009
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  • 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.


    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 Identifier: NCT01983709

    ********************************************************************************************************************* 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


    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


    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.

  • In summary, our results suggest that rMAPCs can be efficiently recruited by vascularized tumors and differentiate to endothelium and thus may represent a useful vehicle for delivery of therapeutic genes to sites of active tumor neovascularization.

    Biochemical and Biophysical Research Communications 364 (2007) 92–99

  • "it is clear that systemically administered MSCs can be recruited and migrate toward tumors. These findings are important because they can be used as a basis for initiating studies to explore the incorporation of engineered MSCs as novel anti-tumor carriers, for the development of tumor-targeted therapies."

    MINI REVIEW ARTICLE - Front. Genet., 27 November 2013

  • Int J Hematol. 2014 Apr;99(4):377-82 (2014)

    Cancer gene therapy using mesenchymal stem cells.

    Uchibori R(1), Tsukahara T, Ohmine K, Ozawa K.
    Author information: (1)Division of Immuno-Gene and Cell Therapy (Takara Bio)

    Cellular and gene therapies represent promising treatment strategies at the frontier of medicine. Hematopoietic stem cells, lymphocytes, and mesenchymal stem cells (MSCs) can all serve as sources of cells for use in such therapies. Strategies for gene therapy are often based on those of cell therapy, and it is anticipated that some examples will be put to practical use in the near future. Given their ability to support hematopoiesis, MSCs may be useful for the enhancement of stem cell engraftment, and the acceleration of hematopoietic reconstitution. Furthermore, MSCs may advance the treatment of severe graft-versus-host disease, based on their immunosuppressive ability. This application is also based on the homing behavior of MSCs to sites of injury and inflammation. Interestingly, MSCs possess tumor-homing ability, opening up the possibility of applications in the targeted delivery of anti-cancer genes to tumors. Many reports have indicated that MSCs can be utilized to target tumors and to deliver anti-cancer molecules locally, as tumors are recognized as non-healing wounds with inflammatory tissue. Here, we review both the potential of MSCs as cellular vehicles for targeted cancer therapy and the molecular mechanisms underlying MSC accumulation at tumor sites.

  • Reply to

    Gil wondered why the deal with Chugai was so easy.

    by scistats Jun 22, 2015 11:36 PM
    scistats scistats Jun 23, 2015 12:57 PM Flag

    I think Chugai probably saw stroke as a long shot that would get Athersys over a barrel. I would like to know what is behind Exhibit 10.1

    Athersys, Inc. submitted an application under Rule 24b-2 requesting confidential
    treatment for information it excluded from the Exhibits to a Form 10-Q filed on May 11,

    Based on representations by Athersys, Inc. that this information qualifies as
    confidential commercial or financial information under the Freedom of Information Act,
    5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly
    disclose it. Accordingly, excluded information from the following exhibit will not be
    released to the public for the time period specified:
    Exhibit 10.1 through May 11, 2025

  • Reply to

    Gil wondered why the deal with Chugai was so easy.

    by scistats Jun 22, 2015 11:36 PM
    scistats scistats Jun 22, 2015 11:38 PM Flag

    Mesoblast, Intrexon and ZIOPHARM to Target Cancers:
    Oct 23, 2013
    Under the terms of the agreement the companies will combine Mesoblast's proprietary Mesenchymal Lineage Cells (MLCs) with Intrexon's RheoSwitch Therapeutic System® (RTS®) platform to co-develop complex transgene enabled cell-based treatments for oncology applications.

  • Now, Chugai will negotiate on their terms a deal better than or equal to Celgene's deal with Mesoblast for cancer.

    The prolific dealmaker [Celgene] paid A$3.82 per share for 15.3 million shares of Mesoblast stock, gaining in return the right-of-first-refusal on a group of stem cell programs that [includes]...certain oncologic diseases...

    Chugai's #1 area of focus according to their CEO is: ONCOLOGY

  • Recent pre-clinical and clinical studies have shown that stem cell-based therapies hold tremendous promise for the treatment of human disease. Mesenchymal stem cells (MSC) are emerging as promising anti-cancer agents which have an enormous potential to be utilized to treat a number of different cancer types. MSC have inherent tumor-trophic migratory properties, which allows them to serve as vehicles for delivering effective, targeted therapy to isolated tumors and metastatic disease. MSC have been readily engineered to express anti-proliferative, pro-apoptotic, anti-angiogenic agents that specifically target different cancer types. Many of these strategies have been validated in a wide range of studies evaluating treatment feasibility or efficacy, as well as establishing methods for real-time monitoring of stem cell migration in vivo for optimal therapy surveillance and accelerated development. This review aims to provide an in depth status of current MSC-based cancer therapies, as well as the prospects for their clinical translation.

    Shah K.
    Massachusetts General Hospital, Harvard Medical School, Boston
    Adv Drug Deliv Rev. 2012 Jun 1;64(8):739-48

  • "The timing of the new partnership with Japanese drug maker Chugai is a bit odd, however, coming just one month before Athersys is expected to announce results from an important mid-stage study." "Chugai's decision to license MultiStem for Japan will look prescient or foolish depending on the stem cell therapy's performance in an ongoing phase II study of stroke patients." -A. Feuerstein

    Chugai has NO interest in stroke.
    It bought into Athersys stroke to access Multistem for oncology.

    Stroke is NOT among Chugai CEO's stated strategic areas:
    #1 Oncology
    #2 Renal diseases
    #3 Bone and joint diseases

    Key reference:
    "Mesenchymal stem cells engineered for cancer therapy."
    Shah K
    Massachusetts General Hospital, Harvard Medical School, Boston
    Adv Drug Deliv Rev. 2012 Jun 1;64(8):739-48