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Wednesday, August 06, 2014 12:19:28 PM
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?
"evil flourishes when good people fail to act"
Recent GERN News
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- Form 8-K - Current report • Edgar (US Regulatory) • 06/07/2024 08:03:44 PM
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