Interesting posts from yahoo board...
John's Phase I IST Mayo Cohort
The IST conducted by Dr. Tefferi since 2012 under IND NCT 01731952 - the IST that saved his life - is now transferred to Geron as of September 30th. This does not mean John will be flying to Menlo Park. It does mean Geron will collect and report his cohort's data (the Phase I Arm A and B data) starting 9/30/14 with Dr. Tefferi remaining as the principle investigator for Geron instead of Mayo. Lucky Geron!
Dr. Tefferi still works for Mayo (not Geron) so Mayo is not "walking away" from anything . Mayo transferred ownership of the MF study IND NCT 017319 sponsorship to Dr. Tefferi so he could then transfer it to Geron so Geron could sponsor the last 4 months of the Phase I IST MF study still on-going (John's study) and also sponsor Phase II that will include John and many others (closer to home - yeah!) now without any delay (as would be the case if Geron had to wait to proceed under the "old" ET IND on hold). However, the Geron ET IND is now a moot issue and completely irrelevant now! Whether that hold eve comes off or doesn't - makes no difference.
Geron has a "new" IND NCT 01731951 not on hold and can begin Phase II after informing FDA of it's intentions regarding any new studies. That is, that there intention to study MF/ AML/MDA and not ET.
Most importantly, the MF IST at Mayo "ceased enrolling patients in January 2014". "...patients remaining in the study - which includes patients with MF (myelofibrosis), blast phase MF, and refractory anemia with ringed siderobalsts, as sub-type of the rare myelodysplastic syndromes (RARS-MDS) - will continue to receive treatment". This means that - given even latest possible enrollment in January 2014 - some patients have very likely exceeded their prognosis. John's IST Phase I MF patients and other patients are still alive and still in treatment at least 9 months later and most much longer. Don't you now believe the ASH data will be awesome?
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ASH will determine the future of Imetelstat and Geron. Either Imetelstat is a great drug (with future potential), or we have been misled. There is no way to hide the truth after the ASH presentations. I have not seen any negative papers to date (anywhere), so I am hoping for the best.
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Advanced Partnership Discussions Under Way
The reason Geron wanted full control of the Mayo IST data is they are in advanced stages of partnership discussion for Imetelstat. The Mayo IST, while only a single center study, is a large enough proof-of-concept to satisfy any partner, especially considering it was conducted by the number one expert in the world, Dr. Tefferi.
Remember, the first Jakafi Phase I/II trial (154 MF/ET/PV patients) was conducted principally by Dr. Tefferi at Mayo Rochester with help from Dr. Verstovsek at MD Anderson (NCT00509899). A smaller Phase II in 41 MF patients was later conducted by Dr. Mesa at Mayo Arizona and Dr. Verstovesek at MD Anderson (NCT01340651). It was Tefferi’s data that Incyte used to convince Novartis to partner with them on Jakafi back in 2009. And it will be Tefferi’s data that Geron uses to partner Imetelstat.
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I believe you are correct. ASH will bring forward all the information about Imetelstat that has been processed, and is in publishable form. The year between ASH 2013 and ASH 2014 has not diminished the science and medical successes for Imetelstat, and the amount of information available has dymacically increased. Most of all, the "negatives" that could defeat Imetelstat in the future do not seem to exist. Dr. T's new position as the coordinator of all Mayo-Geron data and trails is significant, and will lead to new paths and partners for Imetelstat, probably before ASH. As others say, "of course, IMO".
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"There is little chance Geron has the wherewithal to advance Imetelstat on its own. The Mayo data proves the drug works and the side effects are manageable. This is exactly what big pharma wants and Geron has noted in most of its road shows its interest in partnering Imetelstat"
This is most of us believe. Scarlett is there to the best deal possible for Imetelstat, and that will be after the revelations of ASH.
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Tefferi's trial proved the palliative value of Jakafi with reduction of symptoms and spleen size. That's proof of concept. When a drug works and side effects can be managed, big pharma takes notice. Tefferi chose not to participate any further in Jakafi trials because the drug proved unable to modify the disease. If Jakafi were able to eradicate or suppress the disease, Tefferi would have been thrilled to participate further as the drug's side effects are manageable just like Imetelstat's are.
There is little chance Geron has the wherewithal to advance Imetelstat on its own. The Mayo data proves the drug works and the side effects are manageable. This is exactly what big pharma wants and Geron has noted in most of its road shows its interest in partnering Imetelstat.
"evil flourishes when good people fail to act"
