News & Events

2021

SEP 28, 2021

Genelux and Newsoara Announce Collaboration and License Agreement for Oncolytic Immunotherapies

Genelux grants Newsoara exclusive license to Olvi-Vec and to its oncolytic virus library in the Greater China Region

2020

DEC 11, 2020

V2ACT Therapeutics™, LLC Announces FDA Clearance of an IND Application to proceed with a Phase 1/2a Study of V2ACT for the Treatment of Pancreatic Cancer

V2ACT Therapeutics™, LLC today announced that the Company has obtained permission from the U.S. Food and Drug Administration (FDA) on an…

SEP 25, 2020

Genelux Announces Closing of a Strategic Financing Transaction

Genelux Corporation, a privately-held clinical-stage immunotherapy company, today announced that it has entered into a convertible note and warrant…

SEP 16, 2020

Genelux to Present Data from Phase 2 Trial of Olvi-Vec in Heavily Pre-treated Platinum-Resistant/Refractory Ovarian Cancer at ESMO Virtual Congress 2020

Genelux Corporation, a privately-held biopharmaceutical company, today announced that data from the Phase 2 VIRO-15 study evaluating its lead…

SEP 10, 2020

Genelux Announces Oral Plenary Presentation of VIRO-15 Phase 2 Trial Data at the 2020 xDigital Annual Global Meeting of the International Gynecologic Cancer Society

Genelux Corporation, a privately-held biopharmaceutical company, today announced that the abstract covering data from the VIRO-15 Phase 2 trial…

JUN 04, 2020

Genelux Announces Formation of Clinical Advisory Board on Gynecologic Cancers

Genelux Corporation, a privately-held, clinical-stage immuno-oncology company, today announced that it has formed a Clinical Advisory Board (CAB) on…

MAY 07, 2020

Genelux Corporation Announces Productive Type C Meeting with FDA

Genelux Corporation, a privately-held, clinical-stage immunotherapy company, today announced the outcome of a Type C meeting with the U.S. Food and…

“Being a part of the Genelux team means working every day to make a difference in the lives of patients and their families. The challenge, and the satisfaction of making a meaningful difference is what gets us out of bed in the morning.”  – Tony Yu, VP of Clinical Trials

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.