Today the EMA Approves Modification to Imetelstat PIP

[Commsman]

Sorry Biopearl. I didn't mean to suggest these trials are starting on Nov 13 2023 though I can see how my clumsy wording could be interpreted in that way. I meant to say these trials were officially approved in the EU by the EMA as of Nov 13, 2023.

[Commsman]

@mck. I don't have any further details other than the link I provided in the 3rd post of this topic chain which opens the official EMA document which sanctions and approves the investigatory use of Imetelstat in children between the ages of 28 days and 18 years with MDS, JMML, and AML. I don't think even the FDA has approved the use of Imetelstat in children with these diseases for investigatory purposes yet. The IMpress trial clearly states it is for people that are 18 years and older, but I wonder if they might expand it to include children in the France and Germany locations.

[Commsman]

IMpress Phase 2 is an investigator-led study being led by The European Myelodysplastic Neoplasms Cooperative Group (EMSCO) and Australasian Leukaemia & Lymphoma Group (ALLG).

Does this mean the primary funding for this trial comes from EMSCO and ALLG? Of course, I would presume the Imetelstat is donated by Geron.

[kmall]

I would echo Ryans last entry in this thread. While many of us can get overly enthusiastic when minor details occur during the Regulatory process, misinformation or drum beating an opinion doesn't necessarily make it a fact. This most recent modification that was "approved" appears to be a very minor detail..... I'm fairly certain they simply lowered the age from 6 months to 28 days for eligible pediatric AML patients. A VERY big deal if you have a very young child in the EU with AML. However it's not "approval" as we want/wish/and hope for, and it isn't the beginning of a Clinical Trial for pediatrics which has yet to be announced by Geron......we would most definitely see a PR should that be the case.

There is however, and pure SPECULATION/OPINION on my part, that the Australian version of the FDA known as the Therapeutic Goods Administration (TGA), might be moved towards approval for AML/MDS based on Dr. Lanes data - however, we most likely see a PR from Geron for their version of an NDA before that actually takes place. -Kmall