Spark Temporarily Suspends New Enrollment in Study

Industry News
The following is a letter provided by Spark Therapeutics.


“In the unprecedented time of the COVID-19 (novel coronavirus) pandemic, Spark Therapeutics has closely monitored this evolving situation and taken steps to protect the well-being and safety of both our workforce and the patients and families we serve.
In reference to our ongoing gene therapy clinical program in hemophilia A (SPK-8011 and SPK-8016), Spark Therapeutics has consulted with investigators and infectious disease consultants about the impact of COVID-19 on study activities. As our primary concern is the safety of patients, Spark has made the decision to temporarily suspend new enrollment in our ongoing hemophilia A studies.
The decision to temporarily suspend enrollment in our ongoing hemophilia A studies is being done solely out of concern for the overall safety and well-being of clinical trial participants who may receive immunosuppressive regimens as part of gene therapy protocols, and to minimize risk of exposure to COVID-19 for participants who would have been traveling to and from investigational sites.
Spark strongly recommends hemophilia patients adhere to their care put in place by their doctor and care team during this unprecedented time. We also encourage members of the community to follow guidance from the Centers for Disease Control (CDC), the World Health Organization (WHO), local institutions and hemophilia healthcare providers, including practicing social distancing.
As a leader in the field of gene therapy, we have always placed patient safety first and foremost in our research.  During this unprecedented time, we feel this voluntary enrollment suspension is the responsible way to safeguard the well-being of individuals living with hemophilia A and their caregivers who were planning to join our clinical research programs. Spark Therapeutics remains committed to investigating a potential gene therapy for hemophilia A and resuming the SPK-8011 and SPK-8016 studies as soon as safely possible for participants.”

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