Zetagen is a private, clinical-stage biopharmaceutical company focused on developing breakthrough therapies, via local administration, for metastatic and primary bone and soft tissue cancers.
Expanded access, sometimes called “compassionate use,” is a pathway for a patient with an immediately life-threatening condition or serious disease or condition to potentially gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Currently, Zetagen makes its investigational therapies available for expanded access upon FDA approval. Zetagen believes that investigational therapies, following promising and safety in-vivo testing, should be available to patients with life threatening diseases and when all alternative and approved treatments have failed.
Zetagen will evaluate and respond to each request that it receives on a case-by-case basis. Any such request for expanded access to Zetagen investigational therapies must come from a patient’s treating physician and be approved by the FDA.
Our clinical trial programs are the primary way to get access to a Zetagen investigational therapy. Zetagen strongly encourages patients to speak with their treating physicians and when possible, to participate in clinical trials.
Information about our investigational therapies and ongoing clinical trials can be found on https://clinicaltrials.gov/study/NCT05280067.
As permitted by the 21st Century Cures Act, Zetagen may revise this Expanded Access Policy at any time. The posting of this policy by Zetagen shall not serve as a guarantee of access to any specific investigational therapy by any individual patient.
If you have additional questions about our investigational therapies, please speak with your treating physician or contact Zetagen at admin@zetagen.com.