Currently, ASC Therapeutics does not offer an expanded access program. We are early in the development and are still evaluating the risks associated with its investigational gene therapy, mainly related to immune-related side effects at administration, assessment of the optimal dose, understanding of the duration of treatment response, and long-term loss of some or all treatment effects.
For these reasons, ASC Therapeutics has decided not to provide expanded access to its investigational gene therapy until there is clarity on these issues, a decision made after thorough consideration and in consultation with our hemophilia advisory board. Currently, access to our investigational therapy is possible only through participation in clinical trials.
Clinical trials are carefully controlled, regulated, monitored, and conducted in specific patient populations to assess the safety and serve a critical role in understanding the risks and potential benefits of investigational therapeutic options, such as gene therapy.
If you are a patient or family member and have questions about this policy, please contact email@example.com If you are interested in learning more about our current investigational gene therapy programs, visit here for our pipeline and get more information on ClinicalTrail.gov.