On August 25, 2022 xCures, Inc., a clinical study platform provider, and Oblato, Inc., a biotechnology company, reported the availability of OKN-007 through an intermediate size expanded access program (iEAP) for eligible patients with pediatric diffuse midline glioma (DMG), inclusive of diffuse intrinsic pontine glioma (DIPG) (Press release, xCures, AUG 25, 2022, View Source [SID1234618665]). Oblato is currently developing OKN-007 as a treatment for glioblastoma multiforme (GBM).
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Pediatric diffuse gliomas are rare but have a very poor prognosis, and current treatment options show little benefit. Because pre-clinical research and emerging clinical data support the potential for OKN-007 in this population and the life-threatening nature of malignant gliomas including DIPG, Oblato is making OKN-007 available to qualified physicians through the iEAP.
"xCures is pleased to continue our efforts to bring pre-approval access to investigational medications for pediatric cancer patients. We are excited about the underlying science behind OKN-007 and the opportunity to use our platform to generate evidence and accelerate OKN-007 development. Our platform offers an efficient solution for physicians and patients seeking access to promising therapies when clinical trials are not an option," says Mika Newton, CEO of xCures. "xCures’ has a track record of delivering high-value real-world evidence from expanded access programs."
Ki -Hong Ahn, CEO of Oblato comments, "We are pleased that xCures will serve as the partner for the iEAP. With the new protocol now in place, we look forward to initiating this important program for pediatric cancer patients. We will expand the investigation into OKN-007 for DMG and DIPG patients as well as GBM patients."
Interested patients or physicians can learn more at xcures.com/details/okn007/.
About Expanded Access:
Expanded access, which is often called "compassionate use," is the use of an unapproved drug for treatment of patients with serious or life-threatening illnesses outside of a clinical trial. Expanded access is subject to oversight from the US FDA in accordance with the regulations outlined in 21 CFR 312.305.