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Thanks Peter, I asked specifically since the cancer stem cell hypothesis seems so compelling yet Geron has floundered with company sponsored trials testing imetelstat, a telomerase inhibitor. Recently an NCI sponsored study was posted and clinicaltrials.gov which is a phase II trial in pediatric brain tumors. I just wondered if more interest in the drug was reflected in this approach or whether it was simply a dollars and cents decision by the company to not fund where they don't have to. I suppose if there were no potential for the drug the various high power academic institutions participating would be less interested unless the compensation provided for doing the study trumped their pure interest in contributing to the general body of knowledge. bp
Thanks Dew.
General question for the board (read, Dew) Is there any qualitative difference between a company sponsored study vs one sponsored by the NCI? If the NCI is sponsoring a study does that imply some sense that the study is less hopeless (or more hopeful)? What percent of company sponsored trials go from phase II to phase III vs. NCI sponsored trials? Does the company supplying the study drug have ready access to the results or are the results the property of NCI? Is there any insight as to how the NCI selects drugs to test compared to what an individual company might do? Ok I am out of questions for the moment. Thanks for your consideration. Regards, bp
For those who follow GERN (all two of you) there is a new study in pediatric brain tumors and imetelstat Phase II posted on the clinicaltrials.gov site. Regards, bp
Dav, not sure this is the right take away considering there were very advanced NSCC patients. The graphs even with the Fish analysis show some pretty strong trends that might be pertinent if the drug were started in less advanced patients. Also progression free survival seemed to be impacted more that overall survival. Be interesting to see what Geron's PR looks like tomorrow. The real interesting stuff looks like it will be in some hematologic cancers. bp
Dew, any thoughts on the new TEVA MS study of their oral drug released today and the potential effect on copaxone sales? bp
I see Don kindly provided the link. Worth reading the Geron statements post ASH in Dec as well as a perusal of the slides from the presentation available on the Geron web site. It appears they are emphasizing the potential to modify the underlying disease and have molecular confirmation of JAK 2 suppression which may set them apart from current therapies. bp
iwfal, Agree Geron not good re disseminating info witness 8 years of phase I CLL data and solid tumor data never really discussed in any detail. Re your points: PV has never been put forward as an indication, only that there may be commonality in the precursor myeloid cell with ET. Therefore maybe not so very different even though eventual different differentiated cell lines. Agree Geron's data so far only relevant to ET at ASH but PV of interest because of potential effect on same myeloid precursor cell. Holy grail appears to be MF. Found an interesting article that you and Don Shimoda might be interested in: JAK inhibitors for myeloproliferative neoplasms: clarifying facts from myths by Dr. Ayalew Tefferi of Mayo. Dr. Tefferi emphasizes the issue of the importance of "disease modification" via future, more effective drugs and absence thereof with current therapies. Lots of overlap in language with Geron's description of the findings with imetelstat and ET. Worth a read. I am not defending Geron who have spent 20 years and a lot of money only to abandon their stem cell program and put it where? BTX who basically has no money. Their solid tumor program is a disaster. That said it looks to me like the reason they changed course was the potential for disease modification in myeloproliferative neoplasms, so far as I can see this would represent a unique approach the this set of diseases. Regards, bp
Who says they dropped PV? They just stated they had enough data to stop the study. This may not mean the 2 PV patients are not continuing to receive therapy. ButI may have missed something here. The elevated unconjugated bilirubin could be due to hemolysis or an effect on red cell precursors? As you recall the "problem" of throbocytopenia is not such a problem in primary thrombocythemia. Might neutropenia effect in some patients mean an effect on myeloid precursors? Can't speak to the LFT abnoralities but they didn't met Hy's Law so maybe not a huge problem, yet unknown but sure to be made clear as this cohort is followed. How many chemo agents don't have awful side effects? Most patients in the ET study remain on drug so the side effects can't be intolerable. I think the liquid tumor data is remarkable for ET, especially as it pertains to effects on precursor cells, hope it has just been seen through the (dirty) lens of the breast and lung studies so far. Pediatric tumor response who knows, there was some interesting early in vitro brain tumor data... Anyway the stock is a disaster right now but as a good friend reminded recently the enterprise value may reflect this especially since the stem cell assets must have some value too. Regards to all, bp
At least he didn't call it "Memento" ...
Will someone PALEEZE tell Mr. Wheeler the difference between appraise and apprise? Regards, bp
Not too big a risk at .99/share. bp Any ideas when the decisions from the jan 11 SC proceedings will be posted?
iwfal, of course it has advantages over coumadin, I do not love Pradaxa, let me be clear on that but the absolute bleeding risk does seem to be lower on Pradaxa (if dosed properly, see rest of message before reacting) and many bleeds are not life threatening and can be handled conservatively. Patients like it since less blood work is required and dose adjustment (in the absence of renal dysfunction) is not required. Older patients are precisely those who have the greatest difficulty in adjusting their doses of coumadin properly. Having said that I use only coumadin in patients who will need to be anticoagulated during their procedures because of the need to be able to reverse if there is a problem. Cost is a factor also in favor of coumadin. I agree with Dew that once an agent is available that is reversible this will all probably be moot. My statement about not "seeing" the reduction is thromboembolic events was not meant as in comparison to coumadin, it was meant to state that one does see the bleeding complications in the ER but the much greater advantage in reduction of thromboembolic events is (not) "seen" by their reduction. In other words the risk of bleeding is significantly outweighed by the benefit of stroke reduction. The bleeding risk you cite in the elderly may in part be explained by failure to adequately adjust dose for reduced renal function in this population (now being increasingly recognized as very important.) Also the non coumadin oral anticoagulants have a relatively rapid onset and their use can often avoid the need for bridging heparin which carries its own risks. bp
Dew, partially true. With coumadin the options of Vit K and fresh frozen plasma remain viable treatment options to reverse adverse bleeding. With Pradaxa the only treatment option so far is "tincture of time" (and a drug with a much shorter half life.) What really is important is what you don't see and that is a substantial reduction in thromboembolic events. Regards, bp
Rick Shea said they filed for an en banc hearing in todays presentation. Regards, bp
While a legislative approach could present a long term remedy wouldn't it be "after the fact" such that the potential for damage compensation in this case to be much less likely? That is it would change an existing law and prevent a future issue but not apply retrospectively to this case? While an en banc review might result in a different outcome based on current law and allow awarding the damages Momenta seeks. I wasn't sure what would trigger an en banc review since it seemed that a majority of judges had to approve this approach if my reading is correct. Thanks for responding. bp
Marthambles, thank you for your posts. The Chief Judge was quite eloquent and forceful in his dissent. Is his recommendation for en blanc consideration enough to make it happen? If it were to happen would the remand back to the lower court happen first and have to run its course? It appears there was support for summary judgement from from the other two judges. If summary judgement were granted by a lower court would that be the end of it or would there then be a mechanism for further review or appeal? Any idea of a timeline? An en blanc review would give one hope of a fair review and resolution were it to occur. I realize these questions are from one with a non legal background so thanks for your patience in advance. bp
Dew can you please remind us when these three come off patent and if IVG is subject to patent controls as opposed to the known supply issues. Thanks, bp
i beg to differ, not the egg of the curate but of the golden goose. Its good to know they have such resources available since it seems to me a bad idea on their part to thumb their noses at a court order. They will need resources to pay for damages to MNTA. I guess that was probably your point anyway! bp
Dew, thank you for sharing your thoughts. Regards, bp
Dew, I know MNTA is one of your largest holdings. Are you comfortable sharing with the board how this most recent court decision affects your view of things going forward and what your plans are regarding a potential shift in your portfolio? Clearly the stock will take a huge hit tomorrow as all short to mid term drivers of price seem to be disappearing. Fortunately the Bax partnership appears solid and will be a long term driver, Is anyone planning to sell in the hopes of buying back in at a later time once the dust settles? This decision is a pretty big blow to our hopes for a generic copaxone in the near future. Until the court documents can be read I suppose it is impossible to see if an appeal has a prayer of a chance of success, either way we get back in the queue and wait some more. I am considering selling and am looking for arguments for or against from fellow board members. Thanks bp
Any sense if 402 will cross the blood brain barrier? Thanks, bp
Hi Dew, does anyone know if Watson/Amph is selling any product? Should be an interesting conf call. Bp
Dew, sorry i could not reply privately, this is exactly why we no longer do our pulmonary vein isolation procedures on patients on Pradaxa but routinely switch them to coumadin for these procedures. Thanks for the update. bp
I agree, the "beef" will be in the rates of recurrence. There is some evidence however that imetelstat also makes bulk tumor cells less likely to metastasize successfully and also targets rapidly dividing bulk cells that express telomerase and have short telomeres. Nonetheless it make take a long time to see efficacy since the progenitor cells may divide infrequently. bp
A qualified yes in that "normal" stem cells are quiescent in the adult and appear (if I understand it correctly) to divide very infrequently while cancer progenitor cells express high amounts of telomerase (and have very short telomers) that provides the target for imetelstat. Not sure if megacariocytes are an exception as thrombocytopenia is a DLT. bp
Easy for you to say...I don't think my work would look like your work! I'll just post now and then if I see something interesting. Regards, bp
Agreed on all points. Reversibility of these agents as yet an issue. bp
Mcbio, True dat. No compelling clinical data. Some phase I studies of interest and preclinical lab studies but no "compelling clinical data". But it is a new class of drug and is very interesting especially with the Nobel prize recently acknowledging the potential importance of telomerase and cell immortality. gerntalk.com is a pretty good site if you want to read more. Regards, bp
Possibly but maybe not if they come equipped with an "antidote" that is relatively cheap and readily available. Since basic mechanisms of action may be different also it is hard to speculate what the bleeding risk during procedures might be until we get more experience. I have been surprised at how little bleeding we get on coumadin (compared to heparin--worlds apart) during procedures including pacemaker, defibrillators etc. It took a long time for the EP community to abandon "bridging heparin" and just continuing the coumadin but once adopted it sure cut the complication rates. Regards, bp
Dew, Electrophysiologists have developed a comfort level doing complex procedures like Afib ablations on full dose coumadin (INR 2-3) including transseptal puncture. Coumadin is reversible with fresh frozen plasma and (eventually) with vit K. Pradaxa at least so far is not reversible except by time. The importance of this is that if a disaster occurs during a procedure the bleeding risk is higher with the latter drug. Attempts to stop Pradaxa and use heparin bridging can be done but presents its own set of problems which I can outline if you wish. Also some theoretical and maybe not so theoretical rebound hyercoagulation states might also occur (not proven, just suspected by some). In my limited experience with patients withdrawn from Pradaxa for catheter based procedures small clots occurred in two patients on catheter tips (which were fully retrieved) despite adequate heparinization during the procedure. I prefer to do some catheter based procedures with the patients fully coumadinized and rarely have bleeding problems. I agree with this study's findings. For our patients on Pradaxa who anticipate certain procedures, we actually stop the Pradaxa and switch them to coumdin before their procedures. Many switch back at a later time. Hope this helps. Regards, bp
For those board members interested in cancer stem cells. Geron announced today the completion of enrollment in their phase II breast cancer study. They seem to have evolved from referring to the perviously referenced "cancer stem cell" to the perhaps less controversial "cancer progenitor cell" as the target for the agent imetelstat. This is said (by the company) to be the only anti cancer stem cell chemotherapeutic agent in clinical trials that targets this cell population (via telomerase inhibition). I posted previously about this but there was no interest so will not pursue on this board if no one (besides me) wants to discuss. Best regards to all, bp
Hi Peter, don't know if the articles referenced by Dew (have not had time to go back and review them) mentioned imetelstat, a telomerase inhibitor currently in phase II trials (Geron). Geron as you probably know took a hit when they decided to no longer support their stem cell research and essentially shut down their phase I study using stem cells for spinal cord injuries. It seems that there was some benefit in understanding CSCs as a spin off of this research as it appears that telomerase is specific to cancer stem cells (and embryonic cells) and the telomerse inhibitor apparently shows some promise in targeting these cells. DLT is thrombocytopenia (probably a direct effect on megacaryocytes making thrombocythemia a possible clinical target as well). Several phase II studies in progress: myeloma, breast, lung. Worth checking out. Please let me know what you think. Geron has basically decided to refashion themselves as an oncology company. The telomerse story includes Elizebeth Blackburn and colleagues Nobel prize and makes for some interesting reading. Oh, and also some work on antitelomerase vaccines too, using embryonic stem cell derived dendritic cells as a delivery systerm. Wish Dew would consider this companies work as a candidate for the RMF section. Best Wishes, biopearl.
Many here were pleasantly surprised by the PI in favor of MNTA and the increased likelihood they will succeed in doing exactly what they said the would namely defend the patents fully. Since their patent(s) were so wantonly and blatantly violated held up under fire (realizing the legal process to be a lengthy one) I wonder if they might just go for treble damages and move very aggressively to counter the losses imposed by the entry of AG. I don't think its just about reaching a business agreement, but about extracting compensation and damage. I would not think MNTA will be conciliatory and they will bull dog it the same way I expect them to deal with TEVA now they have strengthened IP firepower.. I expect a very aggressive undertone to next Mondays call and maybe a hint as to how they might creatively put the AG genie back in the bottle. bp
Peter, you gave md good advice. Having been burned by the "going concern" issue previously your caution is justified. Looks like he is not prepared to take your advice, not wise in MHO. It was kind of you to look into and respond to his request. Just an observation from the sidelines. Waiting for the judge today in MNTA case...Regards, bp
Zip so why can't Amphastar start at the same place Sanofi does and end at the same place too would that violate Sanofi patents? thanks, bp
Who foots the bill for the legal fees, Novartis or MNTA? bp
Thank you Dew as always. Boy the last thing I would want to see is a corporate buyout especially in a company with such potential for high drama and such a hammered stock value. Regards, bp
Re Geron:Can a fellow boarder help me make sense of something that happened recently re Geron. They have allowed a "poison pill" provision to lapse. The stock has been hammered. They have pretty big cash reserves around 190 mil as quater close but are burning through the cash with multiple phase II studies evaluating imetelstat, a telomerase inhibitor for cancer treatment. Geron has been discussed on this board before and I know Dew has not been too interested in it when I have skirted the subject in the distant past. The embryonic stem cell therapies look very promising but are a long way off with only one cell type in phase I for spinal cord injury. From a practical point of view what does it actually mean that the poison pill provision is no more. Does it mean the company is inviting a take over? They have an extensive patent portfolio and would be very attractive but surely the telomerase therapies/stem cell therapies have considerable value. Any help would be appreciated. Regards, stay cool during the melt down. bp
Dew, post anticipated Copax approval for MNTA your sense that there will be a settlement implies that you don't think MNTA could have an outright litigation win. Do you think MNTAs case not "ironclad" and therefore vulnerable or is it just simpler and shorter (and still lucrative) to just get a good settlement when the time comes. Regards, bp