Oblato’s first-in-class small molecular OKN-007 will be available through a newly opened compassionate use protocol.
xCures, Inc., a clinical study platform provider, and Oblato, Inc., a biotechnology company, are pleased to announce 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). Oblato is currently developing OKN-007 as a treatment for glioblastoma multiforme (GBM).
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.”
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.
Oblato, Inc., a wholly-owned subsidiary of the Korean biotech company HLB Therapeutics, is incorporated in Delaware and has its principal place of business in New Jersey. Since 2016, the Company has been developing a new drug, OKN-007, to treat brain cancers, especially, GBM as a rare disease and DIPG as a rare pediatric disease. Currently, clinical trials are ongoing to investigate the safety and efficacy of a combination therapy with both OKN-007 and temozolomide for patients with both newly diagnosed and recurrent GBM. Oblato has received both rare pediatric disease and fast track designations for DIPG. For additional information about Oblato, please visit www.oblatoinc.com.
xCures Inc. provides clinical study platforms that use AI/ML algorithms to support tumor boards with the allocation of cancer patients to optimal treatment programs and clinical trials. The xCures platform prospectively generates Real World Evidence for investigational and approved therapies. Patient EMR data is continuously collected, stored, and structured into a regulatory-grade format that is ready for use in submissions to the FDA. For more information, contact firstname.lastname@example.org.
This was first released on EINPresswire