Expanded Access

Biothera Pharmaceuticals is dedicated to unlocking the promise of cancer immunotherapy through the development of innovative combination therapies.

At this stage of our drug development program, we are evaluating the safety and efficacy of our proprietary innate immune modulator, Imprime PGG, in combination with various immune checkpoint inhibitors and monoclonal antibodies.  This research is being conducted through clinical trials that—with continued success—may provide the basis for a submission to the U.S. Food and Drug Administration (FDA) for drug approval.

To learn more about our clinical trials, including eligibility requirements for participating in ongoing studies, please visit ClinicalTrials.gov, a government-run database listing private and publicly funded clinical studies conducted around the world.

As part of the drug development process, the FDA allows for Expanded Access or Compassionate Use of investigational drugs prior to regulatory approval.  At this time, we do not have a compassionate use program; however, we will consider providing Imprime PGG for individual patients (Single Patient IND) on a case-by-case basis.  This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and for whom there are no comparable or satisfactory alternative therapy options.

In determining whether single patient access is appropriate outside of a clinical trial, Biothera will consider many factors, including: the strength of available efficacy and safety data; the patient’s medical condition and history;  the benefit-risk profile of our drug in relation to the patient’s case; the potential impact on the clinical development program; and the ability and willingness of the patient’s physician to sponsor the treatment application.

If you are a potential patient and your physician believes you may be a candidate for single patient access to Imprime PGG, please ask your physician to contact us at earlyaccess@biothera.com.  

Biothera anticipates that it will acknowledge receipt of any early access questions or requests within 7 business days of receipt.