Expanded Access (sometimes termed as compassionate use, early access or emergency use) refers to the use of an investigational drug outside of a clinical trial, with the primary purpose of treating a serious or immediately life-threatening disease or condition in patients who have exhausted their treatment options and are not eligible for, or able to participate in a clinical trial. Expanded Access is different from clinical trials in that more comprehensive information about safety and effectiveness are required to be collected in clinical trials.
Currently, Heidelberg Pharma is clinically developing pamlectabart tismanitin (HDP-101) for the treatment of multiple myeloma (HDP-101 study). At this time, Heidelberg Pharma is not offering Expanded Access for its investigational products. The Company believes that investigational products should be studied within the context of a clinical trial and encourage patients to participate in a clinical trial wherever possible. As such, participating in Heidelberg Pharma's clinical trial is the most appropriate way to access pamlectabart tismanitin (HDP-101) at this stage of clinical development. Information about the clinical trials, including eligibility criteria and locations, is available at www.clinicaltrials.gov.
