Expanded Patient Access Policy

Patients are our partners, our inspiration, and are behind our commitment to Celsion’s mission, goals, and development of GEN-1.

Celsion Corporation believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. For more information, visit ClinicalTrials.gov.

At this time, Celsion Corporation is not offering GEN-1 or any other investigational products under the Expanded Access program.

 Expanded access, sometimes referred to as compassionate use, refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected.

A number of factors consistent with the US Food and Drug Administration and other regulatory agencies’ guidelines should be taken into account when considering expanded access.

 They include:

  • The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
  • There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
  • Whether we have the ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients

If you have additional questions, please speak with your physician or contact us.

Celsion may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active. We anticipate acknowledging receipt of requests sent to this email within fifteen business days.