Scope
This policy applies to provision of access to the Lantern Pharma investigational product LP-184 that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time between regulatory approval of an investigational product and its commercial availability in a country.
Policy Statements
Any use of the Lantern Pharma investigational product LP-184 outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including Lantern Pharma policies and procedures. In general, where permitted by local regulation, the investigational product LP-184 supplied via Expanded Access may no longer be provided by Lantern Pharma when it becomes available via the local healthcare system. Lantern Pharma may decide not to provide LP-184 under this policy if the Company does not intend to market the product in the country. Expanded access requests will be considered on a case-by-case basis in a fair and equitable manner.
A. Patient Eligibility Data
To be eligible for access to the investigational product LP-184, patients must meet the following criteria:
- Suffer from a serious or immediately life-threatening histopathologically confirmed recurrent IDH wild type supratentorial GBM.
- Have undergone appropriate standard treatments without success and no alternative treatment is available or exists to treat the disease or condition.
- Are ineligible for participation in any ongoing clinical study of LP-184, which includes lack of access due to geographic limitations.
- The patient’s condition is such that there is evidence of a projected benefit from the use of LP-184 and the benefit outweighs the known or anticipated risks.
- There is adequate information to support appropriate dosing for a special population of patients such as pediatric, elderly, renal or hepatic disease, etc.
- Any other pertinent medical criteria for access to LP-184, as established by Lantern Pharma’s clinically or medically responsible individual.
B. Investigational Product Criteria
In addition to the patient eligibility requirements, the investigational product LP-184 must meet the following criteria:
- LP-184 is under investigation in one or more clinical studies.
- There is sufficient evidence to expect that LP-184 will have an acceptable safety profile for the intended patient population.
- The provision of LP-184 will not interfere with or compromise the clinical development of the product.
- There is adequate supply of the investigational product to support expanded access.
C. Treating Physician Criteria and Responsibilities
The physician(s) attending to the patient(s) who is/are receiving the investigational product LP-184 through compassionate use access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:
- Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
- Any Lantern Pharma requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.
A treating physician may submit questions or requests regarding expanded access to lp-184@lanternpharma.com. The anticipated length of time necessary to acknowledge receipt of a request is up to 3 business days.
