Expanded Access Policy

Purpose:

Theriva Biologics, is dedicated to developing innovative treatments for patients with cancer. We have developed this Expanded Access Policy to provide a pathway for patients who may benefit from treatment with our investigational product VCN-01 outside of clinical trials. As provided by the 21st Century Cures Act, we may revise this policy at any time.

Criteria for Expanded Access:

  • Patient must have a confirmed diagnosis of a serious or life-threatening illness for which our investigational product is being investigated.
  • Patient must have exhausted all standard treatment options and have no other viable treatment alternatives including participation in clinical trials.
  • Patient must meet any additional criteria established by our Company to ensure the safe and appropriate use of our investigational product.
  • There is sufficient evidence that the potential clinical benefit to the Patient of treatment with our investigational product outweighs the potential risks.

Process for Access:

  • The Patient’s healthcare provider must submit a request for Expanded Access to our Company, including all relevant medical information and rationale for requesting access to our investigational product.
  • Our medical team will review each request on a case-by-case basis to determine if the patient meets the criteria for expanded access.
  • If approved, the Patient must provide written informed consent and our Company will work with the patient’s healthcare provider to facilitate access to our investigational product, including providing necessary information and support for administration of the drug.
  • We will monitor the Patient’s response to treatment and report any adverse events to regulatory authorities as required.
  • Expanded access does not guarantee a positive outcome and the patient must be informed of the potential risks and benefits of our investigational product.

Limitations:

  • Expanded access may only be considered in circumstances where VCN-01 is available, and such expanded access will not compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings that are designed to make the therapy available to many more patients.
  • Our company reserves the right to make final decisions on granting expanded access based on medical necessity and available supply of the drug.

Contact Information:

For more information on our Expanded Access Policy or to request access to our oncolytic adenovirus therapy, please contact our medical team at medicalmonitor@therivabio.com.

Approval:

This Expanded Access Policy has been approved by our Company’s executive team and will be reviewed periodically to ensure compliance with regulatory requirements and ethical standards.