Enlivex is dedicated to developing potential new safe and efficacious treatments for seriously debilitating diseases such as knee osteoarthritis. To accomplish this goal, we are currently prioritizing advancing our investigational products through the clinical development process. Enlivex believes that the best way to fulfill our mission is to conduct clinical trials to assess safety and effectiveness and obtain regulatory approval so that our therapies reach as many patients as possible.
As such, we are directing our resources to the execution of the clinical trials necessary to generate sufficient data to apply for, and potentially gain, regulatory approvals to make our medicines available to all patients with the conditions for which we may obtain approval. We are privileged to collaborate with clinical investigators and patients who participate in our studies to further these aims, and encourage patients to speak with their physicians regarding participating in our clinical trials.
We acknowledge that some patients are not, and will not become, eligible for Enlivex-sponsored clinical trials and may lack access to alternative treatment options, including investigational therapies offered in trials conducted by other sponsors. Nevertheless, at this time, in order to advance our objective of delivering these potential therapies to patients as quickly and efficiently as possible, Enlivex does not make its product available through expanded access (also known as compassionate use).
We have considered several factors in reaching this determination, including the non-life-threatening nature of the indication, the potential risks and benefits of our product at its current stage of clinical development, the logistical complexity of supplying and administering a high-quality and safe product outside the clinical trial setting, and our ability to maintain supply for clinical trials from enrollment through completion.
As the clinical development programs progress, it is possible that assessment of these factors may lead us to change this policy and to consider expanded access requests, in which case Enlivex would update this policy. Until such time, Enlivex expects to deny all expanded access requests and will acknowledge receipt of each request and communicate its decision promptly, and in any event within 90 days of receipt.
More information about Enlivex’s clinical trials is available at www.clinicaltrials.gov under NCT number NCT07580716.
If you have any questions about our expanded access policy, please contact info@enlivex.com.