BioMarin has released an update on the impact of COVID-19 on the clinical trial program for their investigational hemophilia A gene therapy valoctocogene roxaparvovec, developed for the treatment of adults with severe hemophilia A.
The release lays out the challenges associated with managing these trials in a pandemic, including burdens placed on patients and support staff travel to study sites, and on the capacity and functioning of the hospitals in which these trials are conducted. The company continues to work in close coordination with health authorities and governmental regulatory agencies globally, following their guidance to ensure the safety of all, including study participants, investigators, and staff.
“For the BioMarin Gene Therapy Clinical Trial program, where possible, and without putting study participants and site staff at risk, study visits are continuing. Where this is not possible, some parts of sample collection and some assessments are being performed in a manner that is in-line with local, regional, and/or national directives and with the utmost attention paid to maintaining appropriate safety precautions for study participants who may have an alternative option to the usual study visits available to them.” states the release.
The company is also encouraging study participants who are in self-isolation to maintain communications remotely with the appropriate staff at their trial site.
For more information BioMarin has referenced the following:
- Visit www.clinicaltrials.gov and type in the study code BMN 270
- Contact BioMarin Medical Information toll free at 1.800.983.4587 or firstname.lastname@example.org
Source: BioMarin, Clinical Development Program Update, April 2020