Medivation's (MDVN) Pidilizumab Positive in Phase I/II Study
Medivation, Inc. MDVN announced preliminary data from a phase I/II study on pidilizumab (also referred as MDV9300) for the treatment of pediatric patients with diffuse intrinsic pontine glioma (DIPG).
The study evaluated the safety and tolerability of pidilizumab as well as key outcomes, such as event-free and overall survival in the pediatric population suffering from DIPG. In the study, patients were treated with the candidate following the completion of standard radiation therapy.
Data from the study revealed that pidilizumab demonstrated potential clinical benefit and safety in DIPG pediatrics patients. In addition, the reported mean event-free and overall survival estimates were 12 and 15.6 months, respectively.
Results were presented at the International Symposium on Pediatric Neuro-Oncology. Meanwhile, Medivation is still enrolling patients in the study.
According to the National Cancer Institute, approximately 300–400 pediatric brain stem tumors are diagnosed every year in the U.S., out of which approximately 75%–80% are DIPGs.
We note that in Dec 2014, Medivation in-licensed exclusive worldwide rights to pidilizumab for all potential indications from CureTech, Ltd. As per the terms of the agreement, Medivation is responsible for the development, approval, manufacturing and commercialization activities related to pidilizumab.
We remind investors that the company was evaluating MDV9300 in a phase II study for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, which was put on clinical hold after the company announced that the mechanism of action of the candidate was not an inhibitor of PD-1. Although the FDA lifted its clinical hold later, the company is planning to submit an amendment to its Investigational New Drug (IND) applications for MDV9300 to modify the production process to support its planned activities on the candidate. It also intends to treat patients with MDV9300 manufactured in accordance to the amended IND.
Medivation currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Bristol-Myers Squibb Company BMY, ANI Pharmaceuticals, Inc. ANIP and Pfizer Inc. PFE, each sporting a Zacks Rank #1 (Strong Buy).
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