NuvOx Expanded Access

Program Overview

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.

Description

This expanded access record is published by NuvOx Pharma to satisfy the public-availability requirement of Section 561A of the Federal Food, Drug, and Cosmetic Act, in accordance with Subpart I of 21 CFR Part 312 (§§ 312.300-312.320). Publication of this record does not obligate NuvOx to grant access to any individual patient, nor guarantee that a request will be approved.

NanO₂ is an investigational systemic oxygen therapeutic under evaluation across multiple indications. It is not approved by the FDA for any use. NuvOx's Phase 2b glioblastoma study (RESTORE, NCT03862430) has reached its enrollment target and is closed to new participants, and NuvOx currently has no other NanO₂ clinical study enrolling patients in the United States. For patients who are not eligible for or able to participate in an ongoing trial, individual-patient expanded access may be a route to receive NanO₂ outside of an approved indication.

Mechanism: Access is structured as individual-patient expanded access under 21 CFR 312.310. The patient's licensed treating physician - not NuvOx - serves as the sponsor of the individual-patient IND, submits the request to the FDA, and holds ongoing sponsor responsibilities, including preparing the treatment plan (dose, route, schedule, duration, monitoring, and toxicity management), obtaining IRB review and approval, obtaining informed consent under 21 CFR Part 50, and meeting IND safety reporting obligations to both the FDA and NuvOx.

NuvOx's role, if a request is granted, is limited to (a) evaluating the request, (b) supplying NanO₂ in a quantity sufficient for the authorized treatment, and (c) providing a Letter of Authorization permitting the FDA to cross-reference NuvOx's existing IND for the chemistry, manufacturing, controls, and nonclinical/clinical information supporting use of the drug, regardless of the specific condition for which access is sought.

Requesting access: Requests must come from the patient's treating physician and be submitted to expanded.access@nuvoxpharma.com, including the physician's name and address, institution/clinic name, an explanation of how the patient meets the criteria above, and the expected IRB submission date with IRB contact information. Patient-identifiable information should not be included. NuvOx acknowledges each request within 72 hours of receipt and evaluates requests on a case-by-case basis; approval of one request does not guarantee approval of future requests.

Eligibility Criteria