Response from Anna Krassowska (Geron) on questions about recent CC

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Fishermangents
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Response from Anna Krassowska (Geron) on questions about recent CC

Post by Fishermangents » Fri Sep 16, 2016 12:10 pm

(From Nosy, posted on SA, 15 September 2016)

Thank you for your email and commentary.

We did put out a press release with information we can include. We stated that encouraging trends were observed in the efficacy data of the 9.4mg/kg arm in the myolefibrosis trial. We will now wait for longer follow up at the important 24 week time point, as per the primary efficacy endpoints, also including the most recently enrolled patients (and not just the first 20 per arm as in the 12 week review). Note that clinical trials of other agents tested in myolefibrosis report data at 24 or 48 weeks and not 12. The early days review was for an early assessment of dosing, and we were able to determine that 4.7 mg/kg was not an adequate dose.

We have also stated in the past that enrollment was occurring at the expected pace for the study, with over 90 patients in this Jak inhibitor relapsed or refractory population.

Also note that the data from the internal review of the MDS study was also encouraging.

But I thank you for your feedback.
Kind regards,
Anna

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