Philadelphia, PA (November 5, 2020) – Oncoceutics, a clinical-stage drug discovery and development company, announced today that it has received grants from Michael Mosier Defeat DIPG Foundation, Dragon Master Foundation and The ChadTough Foundation to fund an Expanded Access program for ONC201 in the United States.
The program will allow Oncoceutics to work with physicians practicing in the United States to provide ONC201 to patients with H3 K27M-mutant glioma, including DIPG, who meet certain eligibility criteria and who cannot otherwise access ONC201 by participating in an ongoing clinical trial. The Expanded Access program has been made available to select hospitals across the United States, though accrual is not yet open to patients. A list of centers that are in the process of initiating the program can be found on clinicaltrials.gov along with their contact information: click here. Patients and their families can reach out directly to these centers to discuss treatment options and enrollment timelines, as enrollment activities must be completed by the treating physician and their respective institutions in collaboration with Oncoceutics before a patient can be treated.
“At Oncoceutics, we have made it our mission to help patients with advanced cancers such as H3 K27M-mutant glioma and DIPG, and we are dedicated to advancing the clinical and regulatory development of ONC201 so that many more patients will have access to the treatment,” said Lee Schalop, MD, Chief Executive Officer of Oncoceutics. “We are grateful for the philanthropic support from the Michael Mosier Defeat DIPG Foundation, Dragon Master Foundation and The ChadTough Foundation as it enables us to provide ONC201 to more patients today while we are working towards our goal of obtaining regulatory approval to help brain tumor patients with ONC201 as a novel therapy.”
“Patients with DIPG and other brain cancers face the devastation of a challenging prognosis coupled with very few treatment options,” said Mark Mosier, Chairman of the Board of Directors of Michael Mosier Defeat DIPG Foundation. “Defeat DIPG, Dragon Master Foundation, and The ChadTough Foundation are funding the ONC201 Expanded Access program to help ensure patients have access to as many options as possible.”
Expanded Access – sometimes called “compassionate use” – provides a pathway for patients to receive an investigational medicine for a serious disease or condition. Expanded Access is often made available when: there are no comparable or satisfactory alternative therapies to treat the disease or condition; patient enrollment in clinical trials is not possible; potential patient benefit justifies the potential risk of treatment; and providing the investigational medicine will not interfere with investigational trials that could support the medicine’s marketing approval for the treatment indication.
ONC201 is an investigational medicine that is being evaluated in Phase I and Phase II trials. Investigational products have not yet been approved or cleared by FDA, and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.
Requests for Expanded Access to ONC201 must be made by a U.S. licensed physician. Oncoceutics does not currently supply ONC201 outside of the U.S. Physicians can request access for a patient by sending an email to email@example.com. For more information about the Expanded Access program, please refer to Oncoceutics’ Expanded Access Policy. FAQs about accessing ONC201 can be found here.
Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds called imipridones that selectively target G protein-coupled receptors for oncology. ONC201 is an orally active small molecule DRD2 antagonist and ClpP agonist in late-stage clinical development for H3 K27M-mutant glioma with additional indications under clinical investigation. ONC206 is the second clinical-stage imipridone that is under clinical investigation for central nervous system tumors. The company is supported by grants from NCI, FDA, The Musella Foundation, Michael Mosier Defeat DIPG Foundation, Dragon Master Foundation, The ChadTough Foundation, the National Brain Tumor Society, and a series of private and public partnerships. Visit Oncoceutics.com or contact Press@oncoceutics.com for more information.
About Michael Mosier Defeat DIPG Foundation
Michael Mosier Defeat DIPG Foundation works to find a cure for brainstem tumors known as diffuse intrinsic pontine gliomas (DIPG), the deadliest form of childhood brain cancer. The Foundation focuses on funding innovative research to find treatments for DIPG and raising awareness of this devastating disease. Visit defeatdipg.org for more information.
About Dragon Master Foundation
Dragon Master Foundation’s mission is to find and accelerate cures for cancers and other diseases by fostering and rewarding a community of collaboration and innovation. We seek to spread awareness, expedite research and kinder treatments, and improve the quality of life for patients and their families. We invite your engagement at www.dragonmaster.org. Dragon Master Foundation’s support included contributions from Friends of Emily Hood, Mithil Prasad Foundation, Musella Foundation for Brain Tumor Research, National Brain Tumor Society, Storm the Heavens Fund, and Team Cozzi Foundation.
About The ChadTough Foundation
The mission of The ChadTough Foundation is to inspire and fund game-changing research to discover effective treatments for pediatric brain cancer, with an emphasis on Diffuse Intrinsic Pontine Glioma (DIPG). Visit www.ChadTough.org for more information.