Early/Expanded Access Policy

Volastra Therapeutics is committed to developing safe and effective therapies for cancer. Our goal is to ensure access to our investigational therapies at the appropriate time and in a clinically appropriate manner for patients.

Volastra’s Early/Expanded Access Policy (EAP) refers to the use of an investigational therapy outside of a clinical trial. This is initiated when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient, which is different from a clinical trial where more comprehensive safety and efficacy data are collected. At Volastra, we recognize and understand the need for an early/expanded access policy for patients who have serious or immediately life-threatening disease and have limited available treatment options.

The decision to establish an EAP is dependent on a number of key factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies’ guidelines. These include, but are not limited, to the following:

  • The illness for which the investigational therapy is being considered must be serious or life-threating, with no other satisfactory treatment options (such as approved products or enrolling clinical trials);
  • There is sufficient evidence that the potential benefit of the investigational therapy to the patient would likely outweigh the potential risks, based on all available safety and efficacy information; and
  • Providing the investigational therapy as part of an EAP will not interfere with clinical trials that could support the investigational therapy’s development or marketing approval for the treatment indication.

At this time, based on these factors, Volastra believes that participation in one of our clinical trials is the only appropriate way to access our investigational therapies. We do not currently provide our investigational therapies for use through expanded access.

If you are a patient who is interested in accessing our investigational therapies, please speak with your physician. You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for Volastra Therapeutics. If you are a physician who is interested in learning more about our investigational therapies, or participating in our clinical trials, please submit a request to info@volastratx.com.