At Genprex, our mission is to develop life-changing gene therapies for patients with cancer and diabetes through unique, innovative science. We are committed to offering new options for cancer patients by combining our lead product candidate with approved targeted therapies and immunotherapies to treat large patient populations who would otherwise not be candidates for those therapies or who have become resistant to them.
An expanded access policy, also known as compassionate use, allows investigational medical products that have not yet been approved or cleared by the U.S. Food and Drug Administration to be provided to patients with immediately life-threatening conditions or serious diseases when treatment within a clinical trial or comparable or satisfactory alternative therapy options are not available.
We understand that certain patients meet the unique needs of expanded access requirements and that patients and families are interested in receiving Genprex’s drug candidates prior to FDA approval.
After carefully reviewing considerations for expanded access, Genprex has determined that it cannot offer its drug candidates for expanded access at this time. We believe that continuing and focusing on our clinical trials is the most appropriate path forward for bringing our drug candidates to patients as quickly and safely as possible. This will enable us to generate the safety and efficacy data needed to determine whether our investigational drug should be approved, helping the many patients who could benefit from our therapies.
We believe in responsibly transforming the lives of those affected with cancer, and we remain focused on bringing our therapies to patients. As we work through our clinical trials and continue to weigh safety and efficacy data, along with determining the risk-benefit of offering our drug candidates through expanded access, we may make updates to this policy in the future.
If you or a family member would like to learn more about Genprex’s clinical trials, we encourage you to work with your physician to see if you are a candidate for one of our trials. You may also find helpful information regarding Genprex’s clinical trials by visiting www.clinicaltrials.gov.
If you have questions about Genprex’s expanded access policy please email us at [email protected].
