PDS Biotech is committed to developing new anti-cancer immunotherapies from our novel immune-activating Versamune® platform, to improve and extend the lives of patients. Our lead product candidate utilizing the Versamune® platform is PDS0101, which is being studied in the treatment of HPV-related cancers. Our current focus is to complete our ongoing clinical trials to demonstrate safety and efficacy in order to obtain regulatory approval and provide widespread availability of PDS0101.
Prior to regulatory approval by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory authorities, patients gain access to investigational treatments, such as PDS0101, by participating in clinical trials. Expanded access, also called compassionate use, enables some patients with serious or life-threatening diseases such as cancer, who would not have otherwise met the enrollment criteria for the clinical trials in progress, to gain access to investigational treatments. Unlike the use of an investigational new drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to gather data on safety, tolerability and effectiveness.
Currently, PDS Biotech does not offer an expanded access program, and does not accept expanded access requests. We believe that access to PDS0101 should be limited to controlled clinical trials until such time as its safety, tolerability and effectiveness for a particular indication has been determined and confirmed by the appropriate regulatory authorities. Patient access to PDS0101 outside of a controlled clinical trial may interfere with the conduct of our ongoing and future clinical trials, and may also disrupt the progress of our development program, which would, in turn, delay access to many patients in need.
Accordingly, while clinical trials are ongoing, we believe participation in our clinical trials is the only safe and appropriate way to access PDS0101.
To learn more about PDS Biotech’s ongoing clinical trials, please click here.
In agreement with the 21st Century Cures Act, PDS Biotech may revise this policy at any time.