Now that we have 64 clinical trials that we have funded (plus a few dozen more where we supported the early stage research) it’s sometimes hard to remember the details of each trial. But there is one you never forget. The very first clinical trial you funded. And we just got some encouraging news about it.
Way back in 2011 CIRM funded a clinical trial with a company called Geron, targeting spinal cord injuries. It was not only the first clinical trial we funded, it was also the first clinical trial involving the use of embryonic stem cells that was approved by the US Food and Drug Administration (FDA).
But in November of that year Geron decided to change its business plan and canceled the trial. We got all our money back – plus interest – but it was still terribly disappointing to us and to everyone who had hopes the research would help people with severe spinal cord injuries.
Fast forward three years and a company called Asterias picked up where Geron left off, getting permission from the FDA to run a clinical trial using the same approach for spinal cord injuries. Once again CIRM funded the project.
The results from this Phase 1 trial were, to say the least, encouraging
But after the initial trial it felt like someone hit the pause button. Asterias was bought up by BioTime which changed its name to Lineage Cell Therapeutics and moved much of the OPC1 spinal cord injury program to Israel. Then last week Lineage announced it was unpausing the program.
In a news release they announced that by moving the program to their cGMP manufacturing plant in Israel they were able to make “process improvements” in the program and, more importantly; “ Lineage intends to meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program by the end of 2020.”
Brian M. Culley, Lineage’s CEO said: “We have worked diligently over the past year to transition all manufacturing activities for the OPC1 program to our in-house cGMP facility, where our experienced cell therapy production team could develop and deploy much-needed improvements and modernization to the production and analytical processes. This work has achieved significantly better efficiency and improved quality control, which we expect will enable a consistent supply of material to support a late-stage clinical trial of OPC1. With these necessary steps now completed, our focus turns to developing a “thaw-and-inject” formulation and superior delivery tools, to enable an easier surgical procedure and facilitate faster enrollment in the next clinical trial. We also are evaluating ways to return OPC1 to the clinic sooner than originally planned, reflecting our view of compelling clinical data which continues to read out from the 25-patient phase 1/2a SCiStar study.”
So, almost a decade after we first became involved with this project, we’re happy to say it’s alive and seemingly well and getting ready to take the next step in helping people with spinal cord injuries. We’ll let you know how it goes.
One last thing. One of the reasons we are such fans of the approach is Jake Javier. We have come to know and admire him and watch him fight back from his injury. He is a remarkable young man in many ways. He is now a student at Cal Poly where they made this video about him.