On July 19, 2021 Oblato, Inc. (the Company) reported that it has received an agreement from the FDA for its plan to submit an intermediate size expanded access protocol for use of OKN-007 in patients with high-grade gliomas (Press release, Oblato, JUL 19, 2021, View Source [SID1234584954]). The company is already developing OKN-007 as a treatment of glioblastoma multiforme.
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In a December 2020 meeting with the FDA, the agency agreed to Oblato’s plan to initiate a clinical trial for diffuse intrinsic pontine glioma (DIPG) pediatric patients, a rare and difficult to treat brain cancer. Currently, the Company is in discussion for this trial with a consortium consisting of pediatric cancer hospitals. The eligible patients who can participate in this clinical trial for pediatric DIPG must meet specific inclusion and exclusion criteria.
Unfortunately, there are many additional patients with similar aggressive gliomas with a poor prognosis and some of these patients will not have access this treatment as they are not eligible for the clinical trial or are unable to get to the clinical trial sites. Based on this difficult situation faced by many patients who have various life-threatening malignant gliomas including DIPG, Oblato recently received an agreement from the FDA that OKN-007 can be administered outside of the clinical trial to both pediatric and adult patients diagnosed with several types of high-grade gliomas under an intermediate size expanded access program (iEAP). The FDA recommended that the Oblato submit a complete protocol for FDA review and feedback. The Company will submit the protocol as soon as possible to initiate the iEAP.
Expanded access refers to a pathway in which patients with serious or life-threatening diseases with no available treatment options may gain access to investigational medical products, which are either under development or have not yet received marketing approved. In particular, iEAPs are used for a wide range of patients in a number of medical institutions. Pediatric and adult patients who will be eligible for the iEAP using OKN-007 include those with gliomas similar to DIPG involving the thalamus, hypothalamus, brain stem, pons, bone marrow, or spinal cord, or midline tumors including malignant gliomas, gangliocytoma, and anaplastic astrocytoma morphologies.
Regarding the iEAP, an official from the Company stated that "After we released the news regarding the development of our new DIPG treatment, several DIPG patient families reached out to the Company asking to participate in the clinical trial. Since DIPG and other gliomas progress rapidly, Oblato wanted to make the treatment available as quickly as possible and to as many of these patients as possible. The Company decided to use the iEAP first to give an opportunity for patients with either DIPG or high-grade gliomas for which there is either no effective treatment or they are ineligible to participate in a clinical trial. Using the iEAP, Oblato can administer our investigational medicinal product even before we initiate the clinical trial. Currently, we are in discussion with a firm experienced with the iEAP and plan to submit the protocol for the iEAP to the FDA as soon as possible."
"iEAP not only meets the target to provide treatment opportunities to patients, but accords with our company’s GBM and DIPG development strategy. There are a number of new orphan drugs that were approved using the clinical data obtained through an iEAP. An iEAP can also be one way to determine the potential benefit and risk through treatment outcomes with various types of patients," stated an official from the Company regarding the strategic background.