Recent test batch challenges scientists
We’ve been happy to share our progress with you — and so much has been accomplished this year! But we also have found that research sometimes leads to more questions than answers.
One area that has challenged us is that the last test batch of Vasalgel made earlier this year turned out to be too thick (viscous). This might sound like a simple issue, but with a complex SMA polymer, nothing is simple! We brought in a number of international polymer experts to help us understand what was going on and have conducted a number of tests over the past months.
We think we’ve nailed down the issues, and have also learned a lot more about the complex chemical composition of Vasalgel in the meantime. The possible silver lining: We think the thicker recent batches may have something to do with the challenges in reproducing successful rabbit reversal results in larger animals, so sorting this out may solve a larger problem.
This work took time — and has held up our ability to move forward with manufacturing, testing and preparation for the clinical trial. Thus the bad news: we won’t be able to start enrolling clinical trial participants until 2017, rather than later this year as planned. For sure it won’t start in the first half of the year. We are very unhappy about the delays — we thought we’d be a lot further along by now — but are looking forward to moving forward with a ramped-up team hitting these issues on all fronts next year.
Medical device experts coming on board
This year we’ve been working to go from a scrappy team with its heart in the right place to a team of experts in manufacturing, quality control, regulatory strategy and clinical trial implementation.
One big success: The new manufacturing consultant got the Vasalgel social venture set up with a company that can successfully mix the thick gel and package/prepare it for use by clinicians. The team has also been comparing different regulatory pathways and creating our quality control program. We are grateful for the support of a major donor, which has allowed us to bring these experts on board. Look for further announcements in 2017 as we take Vasalgel development to the next level.