Pipeline

Overview

We are dedicated to developing safe and effective oncolytic viruses for cancer patients, either as monotherapies, or in combination with other therapies. Information about our investigational products and clinical trials can be found here and clinicaltrials.gov

 

A robust clinical pipeline advancing two programs with significant potential: an Ovarian Cancer program (regional delivery into the abdominal cavity) and a Systemic delivery program (IV delivery)

  • Regional (IPE) route maximizes pharmacokinetics (PK) & tumor tissue exposure
  • Systemic (IV) routes maximize the addressable indications
Pipeline Header

Clinical Trial Phases:

Phase 1

A phase of research to describe clinical trials that focus on the safety of a drug.

Phase 2

A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (the drug’s effectiveness).

Phase 3

A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA).
Genelux Policy

“Our work focuses on patient benefit.  It’s about finding solutions for cancer patients with difficult to treat diseases, and committing long-term to ensure that our solutions ultimately improve patients’ experiences and outcomes.”  – Rob Holloway, M.D.

Expanded Access Policy

Outside of our clinical trials, we 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 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
  • We have adequate supply of investigational drug

 

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.