Serious adverse event on Pfizer's Phase 1B gene therapy trial: Statement from Duchenne UK CEO
Last night we heard news from our friends at PPMD in the US that a young man has died while participating in Pfizer’s Phase 1B Open-Label study. This study is evaluating PF- 06939926 which is Pfizer’s AAV9 Gene Therapy candidate for Duchenne.
Pfizer issued this community letter informing PPMD of the tragic news.
Duchenne UK is deeply upset and heartbroken for this family who made a brave and courageous choice to take part in research. There will be much to learn around what has happened.
Please take a moment to read the letter below from Pat Furlong, founder of PPMD.
“Today we learned that there has been a devastating loss of a young man that was participating in Pfizer’s Phase 1B Open-Label study. This study is evaluating PF- 06939926 which is Pfizer’s AAV9 Gene Therapy candidate for Duchenne.
According to the company, “At this time, we do not yet have complete information and are actively working with the trial site investigator to understand what happened. Screening and dosing in our Phase 1b clinical trial have been paused and we are working closely with the independent External Data Monitoring Committee to review the data. Regulators have been notified and the U.S. FDA has placed the Investigational New Drug (IND) Application on clinical hold. The safety and well-being of the patients in our clinical trial remains our top priority, and we are committed to sharing more information with the medical and patient community as soon as we can.”
Pfizer issued this community letter informing us of the tragic news.
We are heartbroken for this family and know that there is much to learn around what has happened. As a community, we will come together to get through today, and tomorrow.”