The following video involves a discussion of the ongoing OnPrime clinical study (NCT05281471) of the investigational drug Olvi-Vec which has not yet been approved for marketing by the U.S. Food and Drug Administration. It is intended for information purposes only for current OnPrime investigators, clinical staff and those interested in becoming an investigator. No representation is made as to the safety or effectiveness of this product candidate for the use for which it is being studied.
Genelux Corporation is committed to developing safe and effective next-generation immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Our goal is to ensure access to our investigational therapies at the appropriate time and in a clinically appropriate manner for patients.
Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. This is initiated when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient, which is different from a clinical trial where more comprehensive safety and efficacy data are collected. At Genelux, we recognize and understand the need for an early/expanded access policy for patients who have serious or immediately life-threatening disease and have limited available treatment options.
The request for access to a Genelux investigational drug will be considered only if the patient is an eligible patient, meaning:
In addition, prior to setting up an expanded access program or granting a request from an eligible patient’s physician, Genelux will consider whether:
At this time, based on these factors, Genelux believes that participation in one of our clinical trials is the only appropriate way to access our investigational therapies.
If the investigational drug is approved by a regulatory agency for commercial use, including provisional approval, existing expanded access programs will be phased out or modified accordingly.
Patients interested in seeking an expanded access to a Genelux investigative drug should talk to their physician. All requests must be made by the patient’s treating physician by email at EAP@genelux.com. We will, in general, acknowledge receipt of a request for expanded access within five business days. We may ask for more detailed information to fully evaluate a request.
The request for access to an investigative drug can only be considered if the requesting physician agrees to obtain applicable regulatory and ethics committee approvals. We may deny access if the treating physician cannot guarantee an appropriate storage and handling of the investigative drug, which typically requires a temperature controlled deep freezer and follows Biosafety Level 2 safety procedures and precautions. The treating physician must agree to comply with regulatory obligations, including safety monitoring and reporting.
For more information on expanded access from the FDA, click here.
