June 2019

Clinical Trial for Gregory Friedman, University of Alabama at Birmingham, to test a less-toxic approach to treat progressive malignant pediatric cerebellar (brain) tumors

Current therapies for childhood brain tumors like surgery, chemotherapy and radiation are very damaging to the developing brain and can result in significant long-term brain injury. Furthermore, approximately 30-40% of children with brain cancer do not survive. Novel therapies are desperately needmprove outcomes and lessen toxicities. Therapy with a cold-sore virus (HSV) offers an innovative, targeted, less-toxic approach for children with brain tumors. HSV has been successfully engineered to introduce mutations in the virus that prevent infection in normal cells while maintaining the virus’ ability to kill cancer cells and stimulate the child’s immune system to attack to the tumor. We are currently conducting a first-in-children Phase 1 trial of HSV G207 in brain tumors located in the upper part of the brain (cerebrum). We have safely treated 10 children and have seen evidence of significant responses. Our preclinical data indicates that tumor types that arise in the lower part of the brain (cerebellum) are more sensitive to killing by G207 than tumors in the cerebrum. Furthermore, few effective options exist for children with progressive cerebellum tumors. Therefore, we propose to conduct a first-in-human Phase 1 trial of HSV G207 in progressive malignant pediatric cerebellar tumors to determine the safety and tolerability of the therapy. Our secondary goals are to determine the effectiveness of the therapy and the immune response to the therapy. We will also explore specific features of the tumor and in the patient’s blood that may predict a treatment response to oHSV.

The novel drug administration of first-in-children viral immunotherapy in this research study has the potential to impact up to 15 patients with recurrent or refractory disease from brain tumors, which are the deadliest childhood cancers, and the study will be accessible in Alabama. [$200,000]

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