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I think Wheeler said 12-18 months for defining patent issue but any potential settlement (optimistically speaking) longer. bp
MTB, WRT gutting lovonox, it appears the litigation continues. During recent Q and A Wheeler made the point that Momenta lost the injunction appeal but not the case itself which apparently will now go back to the basic issue of the validity of the process patents themselves with a more complete data base (recall the material not turned over to the court from Amphastar). So anyway maybe its not over yet, would welcome the legal eagles take on recent Wheeler comments in this regard. Thanks, bp
Blade I certainly was not referring to Dew when I made my offhanded comment. His input is the input I sought in trying to understand the abstract in the first place. I agree the wording was not as clear at it might have been and only took issue with those who used harsh language to criticize rather than seek clarity. As my esteemed friend Ryan likes to say"surround yourself with those who seek the truth and run like hell from those who have found it" Regards, bp
Nuere, blade and others, quite an interesting week for Geron. More background from at least two patients who seem credible posters on blogs, both with spouses in the program for MF at Mayo and both apparently doing well, one w CR and one with CI. The harsh criticism levied on our interpretation of ASH data seems to have been unfounded as objections re spleen effect, night sweats etc seem to have been laid to rest with NO mea culpas from the hubristic unrepentant perpetrators. Resolution of bone marrow effects in PR and CR patients said to be durable. We should have data from a full forty patients soon. Best wishes, bp
Dew, I am curious as to the logic of Geron issuing new stock at 4.00 today (ran to about 5.50) knowing that the Mayo Clinic would be presenting full data on 40 Patients with myelofibrosis some time in the near future (Dr. Tefferi of Mayo did present at the last ASH 22 patients per recent posts). If the upcoming data is as impressive as intimated and will be used to design a new phase II study in MF why not wait for the data and the anticipated stock run up to issue the new stock at a higher price? Usually when new stock is issued for less than the market price my limited (unpleasant) experience is that the stock usually falls to the level of the issuing price. Clearly not the case here. Anyway your thoughts as to why they didn't wait would be appreciated. On the surface it would mean to me they thought the future data might adversely effect the stock price. They did have over 50 million in cash so I think could have afforded to wait. I suppose they might have just wanted to get started on the new multicenter Phase II study ASAP but in so doing gave up the possibility of issuing at a substantially higher lever. TIA bp
Dew I have no point of reference to know what data dissemination via just an 8k means. Could they be shielding data if in discussions with partners? If Dr. Scarlett is to be believed, he says he actually doesn't know the data until Dr. Teferri chooses to share it with him, is this disingenuous? I do think the 8k telegraphed that the data would be presented in a scientific meeting next (ASCO? June). If the data were great one would think publication in a widely read prestigious journal would be the way to go with 50 plus patients to report. Not sure how to interpret all of this. bp
Iwfal, the data is not their's to report (Geron) it belongs to Dr. Teferri and the Mayo so there is probably some agreement as to who gets to report and where. That is conjecture on my part. The 8K mentions a presentation but I do wonder if it is so groundbreaking as implied why on a publication first like the NEJM? So your reservations are duly noted. Regards, bp
Dew, I think the reason is, this study is a single center (Mayo) IST that was to be (and apparently is) a segue into a larger multicenter study, if data was supportive and it appears to be. The study was to have target completion date in March of this year. The original design called for 29 patients but was expanded when the data was (according to management) "unprecedented" . I think to give credit where due although very early there do appear to be cases of complete reversal of bone marrow fibrosis to the chagrin of the Jak2 believers. There are also cases of symptom abatement and extra marrow effects. Furthermore there may be some effect on other related diseases such as MPD and AML, yet to be shown. According to Geron they just wanted to wait until they got enough data from a single site to know they wanted to commit to a multi center trial. I am not sure I see the irregularity associated with this decision. It is surely material, hence the 8K? Your thoughts as always appreciated. There is certainly bone marrow suppression and at least one death associated with the drug probably due to aggressive dosing to push for remission. The terminology for some on the board is a little different than for solid tumors for example CR means complete remission not complete response. Dr Teferri and other world experts have worked out a careful and complete grading system to assess drug effect. I am not seeing the bad news here others have made out so I do appreciate your take on this greatly. Regards, bp
Dew, not like you to make such a statement without a background check. Initial Mayo study was slated to stop in March 2014 with 29 patients. Study was expanded to include current 79 (!) patients (expansion presumably due to unprecedented CR and PR not to mention CIs and a good ORR). New cohorts were added (not part of original study design) to include AML and another subgroup of also sicker patients (those with ringed sideroblasts). 20 patients who dropped out of study in keeping with proportion of patients who dropped of study when the initial 22 were presented at ASH in Dec (I think it was 5). I am not sure I can agree with your conclusions. On the contrary, new data from AML cohort may soon be available. Consider the JAK2 inhibitors had a fairly substantial drop out rate and did not provide the potential for CR and PRs seen with imetelstat. Drop out rate could be because of advanced disease and potential for recognition that some patients would not likely respond (negative spliceosome mutations?) CRs included resolution of bone marrow fibrosis and the objections of some regarding improvement/resolution of splenomegaly, constitutional symptoms such as night sweats and also the issue of transfusion requirements have been addressed (impressively). Anyway please review in light of these ideas and re comment if you would. Best Regards, bp
Read your response Dew, thanks. Still even if Natco does some tweaking should't it set their clock back that much further? bp
Trouble for Natco? http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0083757
Regards, bp
Re Gern: Scarlett made the point the some patients were advanced enough in their disease to have already undergone splenectomies prior to imetelstat treatment or did not have much in the way of constitutional symptoms when treatment began, so these could not be used as endpoints. My read of the study (criticized harshly by some on the board) is that this is about some fundamental aspects of MF--blood counts, molecular response and reversal of BM fibrosis--everything else as the sages said "is commentary." I don't think the yard stick of JAK2 inhibitors can be used to measure the responses being reported with imetelstat. I do think the company will "unparse" on Monday. Regards, bp
John your post makes excellent sense and helps to understand the wording of the abstract. When one looks at the definition of CR by the working group if, for the purposes of the abstract, BM and peripheral criteria are met for the "CR" group what's left?:
"Clinical: Resolution of disease symptoms; spleen and liver not palpable; no evidence of EMH" by the definition of "true"CR
After only a few months of therapy for some of these patients it seems reasonable to expect these would lag (and some patients did not have constitutional symptoms to begin with). If the bone marrow is made whole, evidence for EMH might certainly lag and surely splenic size and liver enlargement would take some time to resolve. With JAK 2 inhibitors its almost as if the sequence were reversed, improved sx, resolution of splenomegaly etc but no bone marrow effect. First comes love then comes marriage...I'll go with the bone marrow. It doesn't seem too far a leap to get to a "true" CR from here this early in the game. Please let me know what you think. Regards, bp
Blade and others, it seems unlikely Dr. Teferri will face that elite of his subspecialty and have to backtrack his presentation. I think the message is evidence for disease modification not prev described with any other drug. bp
Blade and neure, agree completely-- an abstract by definition is very condensed, uses a lot of abbreviations by convention and also assumes the readership is conversant with the subject presented. There may be a strict word count that limits inclusion of relevant data. This means for example that the definition of CR will not be spelled out within the body of the abstract but certain important aspects of it will be emphasized. For that the reader must look elsewhere and you have. Why the push back from others is purely about denial or failure to review the clear criterion for CR, PR and CI which has been crafted and adapted by a well respected working group of heme/onc specialists to allow for assessment of response rates to treatment that are not subject to interpretation but represent objective data assessment. Dr. Tefferi will be making an electrifying presentation at ASH. Thanks for sharing info Regards and best wishes, bp
Nuere and Blade, time to bring in the reinforcements. The International Working Group for Myeloproliferative Neoplasms clearly states (in addition to other criterion) that CR and PR include "Resolution of disease symptoms, spleen and liver not palpable, no evidence of EMH." If some on the board won't believe you and won't do their homework so be it. I hope you are well and make a lot of money. I enjoy this board a lot. With best regards, bp
Question for Dew: How often have you seen an 8K filed upon acceptance of an abstract for a medical meeting? Geron filed one upon acceptance of an investigator sponsored study in myelofibrosis for upcoming ASH meetings in Dec. I've not seen them do this before (had positive results from ET phase II study last year) so wonder if any import should be attached to this event or is it just routine. If routine it doesn't seem consistant. Has there been a rule change or does it imply something material? Thanks as usual, Regards, bp
nuere, at least its not a poster presentation which implies something substantive. I think they started enrolling only a year ago. I would love to know how to "weight" their contention that the ET study (100%response rate) provides true proof of concept. Are ET and MF similar enough regarding the progenitor cells involve to make such a statement. If so the results could be impressive. This is a single agent trial and my suspicion is the there will be encouraging results but some statement about the need to find more effective combinations etc. bp
Polly, thanks for responding. I of course can't make a strong case there was cause and effect between the article and the price rise as clearly other factors beyond my level of understanding appear to be at play. My main point was that a statement that was apparently not true found its way into public media and there is no overt way to correct it or rebut it. It just seems irresponsible if true. Regards, bp
Dew, I am struck by how easily a "mistake" (Momenta and Cymbalta) finds its way into an article with wide circulation (SA), the following day the stock goes up .60 yet there is no objection or correction (besides your own clarification which I appreciated). It does seem an intentional manipulation that can take place with no ramifications to the author of the article with little or no journalistic standards in place. Its not a clean game is it. Regards, bp
Thanks Dew. bp
I stand corrected, my mistake. Maybe your diagnosis is correct. bp
Dew, recent SA article made mention of Celexa off patent in 2014 and Momenta as a generic competitor. Do you know anything about this? Thanks and Regards, bp
Nuere and other Gern followers: This was quite a remarkable delivery by Dr. Scarlett for a few reasons I think. Lost in the presentation was the information that Dr. Tefferi has expanded the cohort of the second group of MF patients (not just the new cohort of patients with post MF AML) to an undisclosed number, my guess as to this number is "everyone" he is seeing with the disease. This will end up being a fair number of patients since the enroll rate was approx 11 patients every two months. This would suggest if true that he likes what he sees. Also it it is interesting in that unlike blinded phase II studies in which neither the investigators knew all the results nor did Geron until safety monitoring board reviewed and stopped prematurely the solid tumor study, Geron knows the results to date and so does the investigator, Dr. Tefferi from Mayo, who plans to present at ASH. Dr. Scarlett's practiced smugness (I've got a secret but I can't tell you) at todays conference would be very unethical, unprofessional and very misleading (but probably not illegal) unless he had good news indeed, even then it could be argued that we did not get a completely objective presentation, which shareholders deserve. Dew, since you have heard a million of these presentation and can usually parse out the BS from the meat, I wonder if you could be enticed to listen and give us your take. I would really value that. Soon, (within days) Geron will part with its ESC IP to BTX. Interestingly BTX hasn't budged in anticipation but Geron is up about 80% over its yearly low. Will be traveling so might not be able to reply for a few days but will follow any responses which are appreciated in advance. Regards, bp
1984 sounds about right. Halcion days then. bp
nuere, 1 uM conc of imetelstat was used. Cmax 1.4 to 4uM in other pharmacokinetic studies so could have real clinical relevance. No one cares about Geron anymore. It is certainly worth following. bp
Hmmm, must have been before that! I go back a long way. bp
I remember (I think I remember) when it was aluminium. bp
nuere, just read the primary article on pub med. One wonders "why now" as surely imetelstat was tested in combination with multiple agents at Geron central. The last CLD study started in 2005! Also I may be incorrect in posting that Dr. G left Geron. That does not appear to be the case according to the author list. I got the info from a totally unreliable YMB source. Apologies if it is not accurate. Bet there is going to be a lot of "revisiting" imetelstat in the lab coming up. Regards, bp
nuere, you've done it again with a good article that gives (albeit faint) hope to long suffering Geron holders. Of interst is on clinicaltrials.gov there is a CLL study that started several years ago (as a phase I/II) study later downgraded to phase I that has never been "completed". When I asked Geron about this they never committed as to why the study had not been up dated as completed. Perhaps this? Perhaps we might see a modification to the current "inactive" protocol" now that would be interesting. I think Geron in the days of Tom Okarma was expecting a dramatic result with CLL and imetelstat. Clearly this did not happen. I believe Sergi left the company which I found disappointing but am pleased to see him publishing from a first class institution where he apparently landed and has pursued the imetelstat story. Are you able to access the whole article and extrapolate whether the doses of imetelstat used in vivo have clinical relevance? One problem is that while the drug seems to "work" the doses required for effect could be problematic. Perhaps in combination with fludarabine lower doses could be used. I have seen NO benchwork to support the current MF trial and the ET trial allegedly was seen as proof of concept but its hard for me to see ET and MF as the "same disease" although clearly clonal precursors seem to have a commonality. Best regards, please keep relevant articles (and commentary) coming. I think Geron has about 50 million left. If good data then dilution or acquisition or partnership, if bad data, company death. Best Regards, bp
nuere, Am on the clinical side of things (cardiology), got interested in Geron because of cardiac stem cells. Looks like I will be following BTX too these days. Best wishes, bp
nuere, thanks for your kind reply. I was looking for an explanation as to why in other "high telomerase expression" hematologic malignancies, imetelstat was not particularly effective, at least clinically, e.g. CLL and myeloma and the abstract you found might provide a partial explanation if some TERT variants are more sensitive to imetelstat than others and perhaps that's how they should be screening patients rather than looking at telomere length. If PV, ET and MF has a common germ-line gene variant than perhaps the results of the phase II ET study (quite impressive I thought, but not terribly clinically relevant unfortunately because of other well established treatments for ET) might truly extrapolate to other MPNs. Is your background genetics? You seem pretty well grounded here. Thanks for your response. Interesting the the Mayo study has been expanded to include a third cohort of patient with post MF leukemia. It would be wonderful for these patients if some effective therapy could be found. Regards, bp
nuere, what did you take away from this that had relevance to Geron? Thanks, bp
Re Geron: Thanks for abstract. Pretty thick stuff. Imetelstat is not a JAK2 inhibitor so clearly works by different mechanism (telomerase inhibition). TERT variants associated with CLL and breast interesting as both failed to respond to telomerase inhibition in other studies. Any thoughts as to why no data reported in the two PV patients on imetelstat? I estimated that these patients received therapy for at least six month. The ET cohorts showed responses at one month or so, so I was a little concerned that the failure to report data suggested suboptimal response in PV and might put a dent in the proof of concept claim for targeting the common malignant clone in MPN. One hopes it will do so for MF. Geron claimed at least 2 of 11 patients had to have pre specified responses required to take the study forward and the study did move forward so this is positive but any ideas from anyone as to how response is defined? In Gerons myeloma study there were responses as well but no PR or CR which would indicate the long sought remission in the case of MF. Clearly Geron is all in on this one and will soar or destruct when (and if) the MF data from Mayo Clinic (Investigator Sponsored Study) is presented at Dec. ASH. Regards, bp
Judicial equilibrium? I don't think so. Major Kudos to Momenta for winning on indefiniteness. But judicial equilibrium implies to me some sense of fairness. I read the HW rules re enox, and the clear intent was was distorted by the current ruling to include support for abusing the patents required to manufacture the product after approval not before (when Ampha was protected by the Act.) This confidential (or then patent protected information) appeared to shared by the FDA with Amphastar (and the world) in a public way as to undermine MNTA. And it appears Ampha may not have played fair with making all the info avail to the court that they should have. I don't feel equilibrium has been achieved yet and I hope now that there is summary judgment that is clearly wrong headed the USSC will finally set this to rights. I know the chances are low but I doubt MNTA will give it up yet. I hope not. When an ump makes a bad call (enox) sometimes he tries to make it up later in the game (356) in the name of fairness. Regardless a second generic after 356 that is not interchangeable may find significant delay from the umpires at FDA but for entirely valid reasons (non interchangeability) . It is clear that we don't live in a world of equilibrium or complete fairness but a judicially driven political drive to reduce medical costs that includes strange interpretations of law to facilitate competition at the expense of patent protection and the law (which is changeable). Just my opinion. Regards, bp
Oy, I totally missed it. Dew thank you for being non judgmental in kindly pointing out my oversight. Pretty funny actually. Regards, bp
Dew, A timber company? Does this mean you have changed your view on MNTA or is it the three year timeline (?MNTA is a never sell stock). Regards, bp
Hear, hear!! Thank you Dew, bp
Thanks Blade, so far no takers.
How do you think this compares with the Incyte/Novartis Comfort 3 data? Seems they are chasing the same goals and Novartis just reported disease modification which was the Geron holy grail. Am a little leery of Geron these days. Also of note was the absence of data from 2 of Geron's PV patients who had been on med for <6mo. I found that troublesome. Any opinions welcome. Thanks, bp