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Pidilizumab Shows Potential Clinical Benefit and Safety in Children with Diffuse Intrinsic Pontine Glioma (DIPG)

Yavne, Israel 16/6/2016:   Results from a Phase I/II study of pidilizumab in pediatric patients with a rare form of brain cancer termed diffuse intrinsic pontine glioma (DIPG) were presented this week in an oral symposium at the International Symposium on Pediatric Neuro-Oncology (ISPNO) by the study's lead investigator Iris Fried, M.D., Attending Physician, Pediatric Hemato-oncology, Hadassah Medical Center, Jerusalem, Israel. The study, which was exploratory in nature, was designed to assess the safety and tolerability of pidilizumab, as well as key clinical outcomes, such as event-free and overall survival, in this pediatric population. Preliminary data were presented this week

Diffuse intrinsic pontine glioma (DIPG) is a rare and aggressive pediatric cancer which is responsible for the highest brain tumor mortality in children. Approximately 300-400 pediatric brain stem tumors are diagnosed per year in the United States, approximately 75%-80% of which are DIPGs.Children with DIPG experience a median overall survival between 9-12 months and a two-year survival rate of less than 10%. Despite more than 30 years of clinical research, there have been no improvements in clinical outcomes and there are no approved treatments for DIPG.

Data from nine pediatric patients with DIPG who were treated with pidilizumab following completion of standard radiation therapy were presented. The median age of the study population was 6.5 years (range: 3-19 years): eight patients had intermediate risk features and one patient had high risk features. The reported median event-free and overall survival estimates were 12 and 16.5 months, respectively. Three patients with DIPG remained progression-free at 16.3, 22, and 24 months following diagnosis, with one patient experiencing a partial response. Adverse events of any grade reported in at least one treatment cycle include neutropenia, fatigue, loss of appetite, hypertension, nausea, and lymphopenia; only neutropenia and hypertension were reported as grade 3 adverse events. The study continues to enroll patients.

In an announcement made by Medivation, David Hung, M.D., Founder, President and Chief Executive Officer of Medivation., said  "Separate studies have revealed the potential of pidilizumab in hematological malignancies, and these results, while in a small cohort in a rare disease, suggest its potential activity in other conditions,"  Dr. Hung further indicated "We are especially encouraged by these results in a devastating disease that typically leads to such rapid and certain mortality, and we remain committed to advancing the clinical development of pidilizumab as we continue to characterize its unique and differentiated mechanism of action."

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