I have projected for some time now the strong possibility of Prochymal for AMI being submitted for drug approval with Phase 2 data. Basic reasons, it was a large trial with much technology used to collect and monitor data and then the extension of the trial to 5 years to collect survival and CHF prevention results. Here's the rub. OSIR knows the effectiveness of Prochymal for AMI from the data received. They also know if the 5 year data overwhelms, it's a slam dunk for approval. Instead of a Phase 3, wait for the 5 year data. Then the FDA will have to approve with a follow-on confirmatory trial.
Is OSIR going to sit tight with all the Prochymal processes until a partner signs on? Quite possible the delay with Canada defining Prochymal for GvHD reimbursement prices would be OSIR being unable to construct a Confirmatory trial that would satisfy all the countries (those with Expanded Access Programs) that potentially would approve Prochymal for GvHD. Canadian sales need to start happening along with New Zealand.
Friday's news about a sales force for Grafix was a "sight for these sore eyes". Ovation and Cartiform hopefully will be marketed directly by OSIR.
I hope many here share the same outlook...."with the prospect of near term sales execution, things do appear significantly more positive".
The Prochymal confirmatory trial and reimbursement price in Canada will be settled soon, regardless of a partner, and the AMI needs a phase 3 to incorporate the addition of MSC supernatant and start immediately.
There is no time to sit on AMI if Athersys moves forward into phase 2 and aligns directly with Osiris and Mesoblast...don't forget Mesoblast.
Positive Results from Phase 2 Trial of Mesoblast's Adult Stem Cell Therapy Presented at the American Heart Association Annual Meeting
Revascor™, Mesoblast’s proprietary Mesenchymal Precursor Cell (MPC) product for cardiovascular diseases, was safe and well-tolerated at all doses, with no clinically relevant immune responses to donor cells
Revascor™ therapy significantly reduced cardiac mortality and major adverse cardiac events (MACE) in patients with congestive heart failure over a mean follow-up of 22 months
Highest dose of Revascor™ completely prevented any episodes of heart failure hospitalization over 18 months of follow-up.
Search the following if you wish to read what Stats is talking about:
"mesoblasts revascor demonstrates blockbuster potential"
Also here's the trial for mesoblasts AMI study, NCT01781390. It is all foreign and the time to treatment is within 12 hours of AMI. There doesn't seem to be anything anywhere about phase 2b trial for those with CHF, as mentioned with Stats' post.
Considering all the competition, timelines and AMI/CHF trials around the world, it becomes a bit of a mystery why OSIR has extended their trial to include 5 year data. Too many reasons to begin with, however when the 5 year data overwhelmingly prevents CHF, obviously things resolve. OSIR does have the new patent that addresses the ability to produce more effective isogenic stem cells. It is key to manufacture cells and reliably predict efficacy. That in itself, even if we dismiss OSIR's other IP advantages, separates OSIR from its competitors.