Patients with severe or life-threatening conditions may need medical treatments that are not yet approved or accessible in their country. For these cases, pharmaceutical companies have a procurement mechanism for physicians referred to as Expanded Access, Compassionate Use, Early Access or Emergency Use. Zenith Epigenetics’ Expanded Access Program is committed to providing eligible patients access to our investigational medicines when standard therapies have failed or are not tolerated, they are ineligible for clinical studies, and/or no other treatments are available. Information about Zenith Epigenetics’ clinical trials can be found at clinicaltrials.gov.
The policy outlined below provides the general guidelines that Zenith Epigenetics will follow for its Expanded Access Program. This ensures that requests for access to our investigational medicines are evaluated and processed in compliance with relevant legal and regulatory requirements.
Policy
Enrolling in a clinical trial is the safest way to access an investigational treatment, but in many cases, patients are not eligible to participate in a clinical trial. In such instances, Zenith Epigenetics can provide access to our investigational medications through the US Food and Drug Administration (FDA) and the US government under Expanded Access Programs (EAP) and Right to Try (RTT) laws, respectively. Zenith Epigenetics may provide access through our Expanded Access Program by emailing EAP@zenithepigenetics.com but each case must meet the following conditions:
- Patients must meet the following criteria:
- Have a NUT carcinoma diagnosis by NUTM1 immunohistochemistry (IHC) and subsequent fluorescence in situ hybridization (FISH) or ribonucleic acid (RNA) sequencing to identify the fusion partner.
- Have no suitable treatment alternatives.
- Cannot participate in a clinical trial.
- Other serious or life-threatening conditions will be considered but there must be data showing the potential benefits outweigh the risks.
- Providing access should not interfere with any of Zenith Epigenetics’ clinical development programs required for regulatory approval and commercialization. This includes:
- Disrupting clinical trials or participant enrollment.
- Causing drug supply issues
- The treating physician must be licensed and qualified to:
- Safely administer the investigational medicine.
- Follow local regulations for expanded access.
- Monitor and report adverse events as required by local law and company policy.
- For US patients, access can only be granted through single patient IND filed by the treating physician and/or medical institution.
- For international patients (ex-US), access can only be granted based on local laws and regulations for a single patient
Zenith Epigenetics will confirm receipt of Expanded Access Program inquiries within five (5) business days. Inquiries will be evaluated and approved on a case-by-case basis. Medications will be provided free of charge but requesting institutions will need to cover courier costs. Zenith Epigenetics may close the program at any time for various regulatory or logistical reasons. This policy is also subject to change and its posting does not guarantee access of any medicine to any individual patient.
