One of the Company's lead product candidates is MAT2203, on oral formulation of amphotericin B based on the Company’s proprietary lipid nanocrystal (LNC) platform delivery technology. MAT2203 is currently being investigated in a Phase 2 clinical trial for the treatment of cryptococcal meningitis and is being prepared to enter a Phase 3 clinical trial for the same indication. The Phase 3 clinical trial is intended to provide the basis for a submission for drug approval to regulatory authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Matinas BioPharma believes that participation in clinical trials is the most appropriate way to investigate MAT2203 because clinical trials are conducted according to current standards of clinical care and in compliance with applicable regulations. The details regarding all ongoing or planned clinical trials, including eligibility requirements, are published in public databases such as clinicaltrials.gov.
However, we recognize that there may be patients for whom participation in a clinical trial may not be an option. These patients may seek access to investigational drugs prior to regulatory approval through a compassionate use or expanded access program.
Based upon the preliminary safety and efficacy data that has been generated to date in our clinical trials, Matinas would consider a request for a patient with an invasive fungal infection for whom no alternative treatments were available on a case-by-case basis through a limited emergency access program.
Matinas will consider such special use outside of a clinical trial when the following criteria are met:
This policy may be reviewed and amended in the future. For additional information about this policy, please contact us at email@example.com.