OKN-007 for patients with Diffuse Intrinsic Pontine Glioma (DIPG)
Oblato Inc. will consider individual single patient access to OKN-007 in the United States for patients with Diffuse Intrinsic Pontine Glioma (DIPG), who cannot be treated by currently available drugs or clinical trials.
The primary option for patients to get access to investigational drugs is to participate in a clinical trial. Patients and physicians can learn more by reviewing information on current or planned clinical trials that is maintained by the U.S. National Institutes of Health.
We recognize, though, that there are extraordinary circumstances where access to these investigational drugs outside of a clinical trial is appropriate. Under our Access to Investigational Drugs Policy, a patient’s physician can request consideration for access if five basic criteria below are met:
- Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.