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FDA Grants Fast Track Designation to ONC201 for the Treatment of Adult Recurrent H3 K27M-mutant High-Grade Glioma


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)

 This is an exciting experimental treatment for gliomas that have the H3 K27M mutation, which is usually found in DIPG, brainstem glioma, Spinal Cord Gliomas, Midline Gliomas, And gliomas in the Thalamus.  The Musella Foundation has been supporting this treatment for years, giving 3 grants to help speed up the development!

 


Posted on: 11/22/2018

 

FDA Grants Fast Track Designation to ONC201 for the Treatment of Adult Recurrent H3 K27M-mutant High-Grade Glioma

 

Philadelphia, PA (November 12, 2018) – Oncoceutics, Inc., a clinical-stage drug discovery and development company with a novel class of compounds that selectively target G protein-coupled receptors for oncology announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Oncoceutics’ investigational cancer drug ONC201 for the treatment of adult recurrent H3 K27M-mutant high-grade glioma.
 
The FDA’s Fast Track designation is intended to facilitate the development of new therapies for serious or life-threatening diseases or conditions and with the potential to address unmet medical needs for such diseases or conditions. A company with an investigational medicine receiving Fast Track designation may be eligible for more frequent communications with the FDA and may receive an expedited review of the new drug application.
 
“It is exciting to see a therapeutic option emerge from translational research into a formal clinical development program for a devastating disease such as H3 K27M high-grade glioma,“ said Patrick Y. Wen, MD, Director of the Center For Neuro-Oncology at Dana-Farber Cancer Institute. “Novel therapeutic approaches are important for our recurrent midline glioma patients who currently do not have effective treatment options.”  
 
 
About Oncoceutics
Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds, i.e., the “imipridones”, that selectively target G protein-coupled receptors for oncology. The first lead compound to emerge from this program is ONC201, an orally active small molecule DRD2 antagonist. The company is supported by grants from NCI, FDA, Musella Foundation, XCures, Cancer Commons, and a series of private and public partnerships.
 
Visit Oncoceutics or contact Press@oncoceutics.com for more information.

 




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