(Total Views: 592)
Posted On: 10/16/2020 1:54:44 PM
Post# of 149265
Here's an interesting PR tidbit from Medicenna, a company I follow but am not invested in at the moment, which will use external study results as a control arm. It makes all the sense in the world when you are trying to test a life-saving or life-extending drug. People shouldn't have to miss out on the trial drug if there's a way to avoid it. I could see this happening with Covid as more and more data comes out from trials to make it viable. Coincidentally, this is a company working on a treatment for Glioblastoma. We have some skin in that game too. Might come into play down the road for us.
“We believe that this approach may provide us with the opportunity to deliver high integrity, robust overall survival data for MDNA55 in rGBM while minimizing the number of patients randomized to standard of care in this difficult to treat population. Conventional randomized control trials have been routinely required for registrational studies for new oncology therapeutics, and to our knowledge this groundbreaking design may be the first in oncology to include a substantial external control arm in a trial designed to support regulatory approval. This is expected to reduce overall enrollment requirements, expedite the time to study completion and invigorate our efforts to execute on a partnership strategy for future development. We look forward to providing additional updates on our clinical timelines and partnership discussions as our plans progress.”
Here's the full link if you're interested:
https://seekingalpha.com/pr/18046252-medicenn...of-phase-2
“We believe that this approach may provide us with the opportunity to deliver high integrity, robust overall survival data for MDNA55 in rGBM while minimizing the number of patients randomized to standard of care in this difficult to treat population. Conventional randomized control trials have been routinely required for registrational studies for new oncology therapeutics, and to our knowledge this groundbreaking design may be the first in oncology to include a substantial external control arm in a trial designed to support regulatory approval. This is expected to reduce overall enrollment requirements, expedite the time to study completion and invigorate our efforts to execute on a partnership strategy for future development. We look forward to providing additional updates on our clinical timelines and partnership discussions as our plans progress.”
Here's the full link if you're interested:
https://seekingalpha.com/pr/18046252-medicenn...of-phase-2
(3)
(0)
Scroll down for more posts ▼