NuvOx Expanded Access

NanO₂ is an investigational drug being studied by NuvOx Therapeutics. It has not been approved by the U.S. Food and Drug Administration (FDA) for any use. This record describes a way for a patient's own doctor to request NanO₂ for that patient outside of a clinical trial, through a pathway called "expanded access" (sometimes called "compassionate use"). This option may be considered for patients who have a serious or life-threatening illness, who have already tried other available treatments, and who cannot join an ongoing NanO₂ clinical trial. NuvOx's RESTORE study in glioblastoma has finished enrolling patients, and NuvOx does not currently have any other NanO₂ study open for enrollment in the United States. Under this pathway, the patient's treating physician - not NuvOx - applies to the FDA and manages the patient's care. NuvOx's role is to review each request, and if approved, provide the drug and the regulatory information the FDA needs to evaluate it. Each request is reviewed individually, and approval is not guaranteed.

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* Inclusion Criteria:

  1. Patients must have a condition that is serious or immediately life-threatening.
  2. Patients must have exhausted other treatment options or are ineligible to participate in ongoing clinical trials.
  3. The potential benefits of treatment with NanO₂ must outweigh the potential risks, as determined at the discretion of the treating physician and NuvOx.
* Exclusion criteria:

  1. Providing NanO₂ for the requested use will interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the use.

     * A request will be evaluated against the criteria of 21 CFR 312.305(a) and 312.310(a).

       * NuvOx will consider the totality of available information, including applicable nonclinical and clinical experience, the patient's condition, and the treating physician's rationale for use.