Expanded Access Policy
A promising new area of cancer treatment is oncolytic virus immunotherapy which exploits a virus’s ability to preferentially infect and destroy tumor cells while eliciting innate and adaptive immune responses against cancer. Genelux Corporation is dedicated to developing safe and effective oncolytic viruses for cancer patients, either as monotherapies, or in combination with other therapies. Information about Genelux investigational products and clinical trials can be found here and clinicaltrials.gov>
Outside of our clinical trials, Genelux may provide physician-requested expanded access to its investigational products under limited situations. The request for access to a Genelux investigational drug will be considered only if all of the following criteria are met.
- The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies;
- The patient is not eligible for or unable to participate in a clinical trial;
- The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition;
- A benefit-risk analysis suggests that the benefit from using of the investigational drug outweighs the known or anticipated risks based on evolving clinical data;
- Genelux has adequate supply of investigational drug;
Once 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. Genelux will in general acknowledge receipt of a request for expanded access within 5 business days. Genelux may ask for more detailed information in order 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. Genelux may deny the 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.