November 16, 2017 - DURHAM, NC: A Phase 1 clinical trial leveraging the re-engineered polio virus is now open for enrollment to children 12 years and older at the Preston Robert Tisch Brain Tumor Center, Duke University Medical Center. After years of following the progress of this promising therapy against adult glioblastoma and working with the research team on behalf of children, Solving Kids' Cancer teamed up with The Andrew McDonough B+ Foundation to help move this forward in a trial for pediatric brain tumor patients.
"We have seen dramatic responses in some of the adult trial participants who have universally fatal recurrent glioblastoma," said David Ashley, Director of Pediatric Neuro-Oncology, Preston Robert Tisch Brain Tumor Center at Duke. "We are grateful to Solving Kids' Cancer and The B+ Foundation for enabling us to expand our study and test the approach in pediatrics, where children with high-grade brain tumors often face an equally devastating prognosis."
In 2016, the FDA granted "breakthrough therapy designation" to prioritize research into the re-engineered oncolytic poliovirus (PVS-RIPO), citing evidence that the ongoing phase 1 study for adults has shown increased survival rates among some early study participants with grade 4 malignant gliomas. The treatment has already received a wealth of attention from the oncology research community and was featured on 60 Minutes twice (March 2015 and May 2016). Collaborative funding from Solving Kids' Cancer and The B+ Foundation will help cover the cost of the clinical trial, providing promising oncolytic virus therapy to eligible children with high-grade brain tumors.
The new pediatric trial will enroll 10-15 children with recurrent high-grade gliomas, and the PVS-RIPO poliovirus will be delivered directly to the tumor by convection-enhanced delivery (CED), just as it is in the adult trial. CED is an emerging technology that delivers agents directly to the tumor in the brain using a small, surgically inserted catheter.
"The childhood cancer community has been waiting for an opportunity like this for decades, and we are so proud to see it come to fruition," said Joe McDonough, Co-Founder and President, The B+ Foundation. "It brings hope to many families who are now able to enroll."
For more information about the PVS-RIPO pediatric clinical trial, visit clinicaltrials.gov.
To contact Duke about potential enrollment, you can call 919-684-0000 or email/call the clinical trial team below:
David Ashley, MBBS, FRACP, PhD
Eric Thompson, MD
Charlene Flahiff, MS