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Zalicus AŞ Message Board

scistats 95 posts  |  Last Activity: 8 hours ago Member since: Apr 5, 2009
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  • "Heat-activated ‘grenade’ to target cancer

    Liposomes – structures built out of cell membrane - are used to carry drugs into cancer cells

    The team has fitted liposomes with a heat-activated trigger
    The trigger allows researchers to CONTROL when the drug is released to target the cancer

    Professor Kostas Kostarelos

    Researchers have developed cancer drug-packed ‘grenades’ armed with heat sensitive triggers, allowing for treatment to be targeted DIRECTLY AT tumours, according to two studies due to be presented at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool."

    Sentiment: Strong Buy

  • "Compounds of the present invention can also be administered in the form of liposome delivery systems, such as small unilamellar vesicles, large unilamellar vesicles, multilamellar vesicles and the like. Liposomes can be formed from a variety of phospholipids, such as cholesterol, stearylamine, phosphatidylcholines and the like."

    Sentiment: Strong Buy

  • scistats scistats 19 hours ago Flag

    That would be the liposome containing imetelstat merging and moving through the plasma membrane via endocytosis taking imetelstat with it or depositing it into the cytoplasm.

  • scistats scistats 19 hours ago Flag

    The membrane has the consistency of an oil and is dynamic, not hard or fixed like a shell. Simple diffusion facilitates the movement of small molecules such as oxygen. Imetelstat is far too large to diffuse across the membrane, to my knowledge. Maybe it could be moved in by a transporter, but I am sticking with merge and move through theory as in fusion and endocytosis. Regardless, Janssen obviously has some ideas of they would not be sticking around further investing in imetelstat's chemistry.

    Sentiment: Strong Buy

  • scistats scistats 20 hours ago Flag

    Liposomes can merge with and move through the membrane. There are several novel ways to package imetelstat into a liposome, and Janssen likely evaluated these before moving forward. In addition Geron has mentioned liposomes in detail in its patents.

    Naked imetelstat 1.0 is effective for the current two indications currently clinical trials, but Janssen obviously has bigger plans and want to tackle the problem of toxicity. Once this is overcome, look out.

    Sentiment: Strong Buy

  • scistats scistats 22 hours ago Flag

    Imetelstat is potent an must be put on target.
    JNJ intends to do just that!

    Sentiment: Strong Buy

  • Janssen knows this and plans to put imetelstat on target by liposome delivery.

    " Imetelstat demonstrated intratumoral and PBMC target inhibition; the regimen proved too toxic in children with recurrent CNS tumors."

    Sentiment: Strong Buy

  • scistats scistats 22 hours ago Flag

    Be advised.
    Be advised.

    Sentiment: Strong Buy

  • Reply to

    scistats

    by trailblazer1777 Sep 22, 2016 9:50 AM
    scistats scistats Sep 22, 2016 3:29 PM Flag

    No new safety signals were identified because the first list was unabridged to medical science. Insufficient number of patients meeting criteria but warranting further investigation due to "trends" is bloody scary without an explanation that 12 weeks actually tells us nothing, especially in a population that is so challenging to treat they have never before been studied per CEO Scarlett. A population medical science knows little about! Beside this it was an upbeat conference call.

    Come on now, I already said the Mayo Clinic found CR's and PR's, and Janssen is just circling our camp like hyenas making noises that sound very much like the conference call transcripts you just cited.

    Sentiment: Strong Buy

  • scistats scistats Sep 22, 2016 3:16 PM Flag

    Knight, I feel like MACK is back from the dead with today's signs of life!

    We have a range of possibilities for today's action. Let's just hope we get good news to back this up. Once the cash burn is addressed, look out.

    What could it be?
    1. Onivyde sales are up?
    2. The Allergan manufacturing agreement finally came through?
    3. A new partnership?
    4. EU Onivyde approval?
    5. Trial halted because results were too awesome to wait any longer?
    6. Silver Creek finally struck gold with their Smart Growth Factors?
    7. Buyout?
    8. Market correction..?

    Sentiment: Strong Buy

  • Allergan manufacturing agreement mentioned May 19, 2016 9:00 AM ET Merrimack 2016 R&D Day???

  • Reply to

    scistats

    by trailblazer1777 Sep 22, 2016 9:50 AM
    scistats scistats Sep 22, 2016 2:06 PM Flag

    No doubt about it, imetelstat 1.0 does have value. Dr. Tefferi demonstrated this, and Janssen knows the complete and the partial remissions (CR and PR) he identified are real. Imetelstat 1.0 addresses 20% of the MF population, but with some reversible side effects. Janssen can even identify the patients using biomarkers. Nevertheless, Dr. Tefferi will not be excited until we can get imetelstat on target with lower side effects to address substantially more patients with less risk.

    It is really sad for Janssen to pat CEO Scarlett on the bottom and send him out to read a premature, 12 week press release that planted seeds of doubt about the MF trial's chances of success MDS's trial subjective "cost benefit". What carefully crafted words they were! This came across as Janssen trying to play dirty pool with the both trials to low ball Geron PPS down and try to get imetelstat for little to nothing on "D-day" fear.

    Imetelstat 2.0 in liposomes is a mega blockbuster on the order of Imbruvica. Imetelstat 1.0 is good, but 2.0 will be stellar. Janssen knows it, CEO Scarlett knows it, we all know it.

    What amazes me is how the market is waiting for these trials with bated breath. The results are WHATEVER Janssen wants them to be in terms of the executive decision. It is entirely up to them to proceed or not, regardless of the results. This gives them leverage.

    The leverage Geron has is the 20% opt-in, and Abbvie knows what 20% of an Imbruvica can mean. "AbbVie Expects Imbruvica Revenues to Reach $5 Billion in 2020".

    So the market and Janssen's two "trials" which it has total discretion over with some of THE MOST CHALLENGING MF PATIENTS ON THE PLANET......pffffffffffffff...give me a break!

    With Mayo Clinic's proof that imetelstat works, this is just a dog and pony show that Janssen is running. Why don't they just fess up and tell us what is really on their minds...targeted imetelstat delivery which is already a go.

    Sentiment: Strong Buy

  • Reply to

    scistats

    by trailblazer1777 Sep 22, 2016 9:50 AM
    scistats scistats Sep 22, 2016 11:09 AM Flag

    I should also point out that Dr. Tefferi, in his latest video, said he was not excited about any of the candidates in his presentation, which included imetelstat. He said it take a lot more than this to get him excited.

    Having the most experience with imetelstat in the clinic, this means he is not excited about the current trials.

    So, Janssen takes an unexciting candidates like imetelstat and tests it on the most challenging MF patients. If you designed a trial to succeed, would you not simply test it on a population where it has demonstrated success instead of venturing to new frontiers of what Dr. Scarlett calls the unknown. Not exactly designed to win the battle but instead win the myelofibrosis war.

    If Dr. Tefferi is not excited with a population where imetelstat has show success, then why is Janssen excited. Is Janssen only excited about the Myelodysplastic Syndrome (MDS) trial that appears to be proceeding well for which they may submit a late breaking talk or poster at ASH 2016 per Dr. Tefferi?

    No, there is much more here that has sparked Janssen's imagination, and it is NOT imetelstat 1.0. It is imetelstat 2.0 in immunoliposomes putting drug only target and reducing side effects.

    This would excite Dr. Tefferi, I assure you. In the meantime, the market can do as it wishes.

  • Reply to

    scistats

    by trailblazer1777 Sep 22, 2016 9:50 AM
    scistats scistats Sep 22, 2016 10:43 AM Flag

    In its current form, imetelstat has off target toxicity.
    Everybody knows this. Dr. Tefferi has highlighted it in every paper published to date.
    But, Janssen is not here for off target imetelstat 1.0 are they?
    They are here, and everybody know it, for imetelstat on target 2.0 delivered by immunoliposomes.
    I concur with cheng_ho, and I also concur with Janssen. We have a winner.
    We have an on target, imetelstat 2.0 winner or Janssen would not be here extending their relationship into our imetelstat nuecleic acid chemistry platform.
    We maintain 20 percent opt-in rights and a lot of cash, but the latest agreement suggests an agreement has been determined.

  • scistats scistats Sep 22, 2016 9:24 AM Flag

    Janssen has designed its trials so that it can argue a lack of efficacy in the MF trial and side effects in the MDS trial.

    Janssen obviously chose the most challenging MF population for the current trial (NCT02426086). CEO Scarlett cautioned that little is known about patients who have, "Documented progressive disease during or after JAK inhibitor therapy". This is a risky, risky trial to say the least.

    The Myelodysplastic Syndrome (MDS) trial (NCT02598661) appears to be holding up much better, but Janssen threw the side effects zinger at the market by cautioning: "A decision on whether to move forward...will be based on an assessment of the benefit/risk profile". Basically saying, maybe, maybe not.

    So Janssen could threaten to drop theMF trial for imetelstat citing efficacy and the MDS trial because of a subjective benefit/risk equation that they alone decide.

    Meanwhile, both parties (Geron and Janssen) know that the entire imetelstat franchise as well as the related nucleic acid chemistry comes down to taking toxicity off the table with liposome delivery.

    This would turn what is a marginal drug into a blockbuster.

    CEO Scarlett did read their horrible, premature 12-week MF press release, but he still holds opt-in rights for 20%, and he is willing to call Johnson and Johnson's bluff if they threaten to walk. He knows he can re-partner with the liposome delivery. I think CEO Scarlett would be happy to tell Janssen not to let the door hit them on their way out, and they know this too.

    I think Johnson and Johnson wants to get started with the new delivery system to remove the limitations of imetelstat and turn it into a mega-blockbuster. If they fail both trials and try to low ball CEO Scarlett, I think he will sell the opt-in rights to the liked of Abbvie with the liposome details.

    I see JNJ paying 20 PPS if Geron plays it cards right, but in the face of two JNJ trials designed to failed, it may be difficult to endure.

  • scistats scistats Sep 21, 2016 10:24 PM Flag

    Black, think about it.
    Imetelstat is toxic as hell, but Janssen, for some reason, is Geron's best friend.
    Weird, uh?
    Well, not really.
    If they have a delivery system with specificity for cancer, and if you read the patents they do, the love affair makes a lot more sense.
    The trial results do matter, but a buyout will happen either way. One success, two successes, no naked imetelstat trial success.
    Janssen and Geron have a way of putting imetelstat on target (probably liposomes) which changes everything.
    To be on the safe side, the 20% royalty per the opt-in is just enough to hold Janssen over a barrel, and Abbvie would love to have access since they are already Imbruvica buddies. Of course it is for sale!

  • scistats scistats Sep 20, 2016 11:26 AM Flag

    Opting out would kill Geron's only leverage.
    Much better to sell out than opt-out!

  • These findings suggest that combination therapy of imetelstat and DNMT inhibitors may have synergistic anti-leukemic efficacy in high risk AML patients. Blood 2015 126:1267

    "Janssen has an industry-leading pipeline in heme malignancies," Pamela Van Houten, a spokeswoman for Janssen, told BioWorld Today. "The addition of imetlestat strategically complements our growing myloid portfolio, including Dacogen [decitabine]," a Janssen-backed therapy approved for the treatment of patients with myelodysplastic syndromes in May 2006.

    Sentiment: Strong Buy

  • scistats scistats Sep 20, 2016 10:30 AM Flag

    Why choose to opt-in?
    Much higher world-wide royalty, and if Geron does not opt-in they will have no further rights to conduct any independent imetelstat development.
    This is why they need to sell the opt-in rights to another big pharma or opt-in themselves because the mega pay will come when imetelstat is put in a liposome for delivery to put 95% of drug on target for higher efficacy and much better management of side effects.

    Sentiment: Strong Buy

  • scistats scistats Sep 20, 2016 10:00 AM Flag

    By put it in a liposomes, I mean that I think imetelstat is destined to be delivered inside an immunoliposome platform!

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