BioLineRx cares deeply about the patients living with the conditions that we are researching. We work every day to bring potential therapies closer to patients. BioLineRx is advancing an innovative pipeline of therapeutics for patients with cancer and rare diseases. To accomplish this mission, we conduct clinical trials to assess the safety and efficacy of our product candidates. The data generated from these trials allows us, potentially, to obtain the necessary marketing approvals from regulatory bodies such as the U.S. Food and Drug Administration and the European Medicines Agency. For a list of our clinical trials currently recruiting patients, please visit www.clinicaltrials.gov None of our investigational candidates, however, have been deemed safe or effective, nor have any been approved by any regulatory agency.
In general, patients obtain access to investigational agents prior to regulatory approval by participating in clinical trials. BioLineRx considers participation in our clinical trials to be the best way to access our experimental therapies. There may, however, be circumstances in which a patient is facing a serious or life-threatening condition, has exhausted available treatment options, and/or is unable to participate in a clinical trial. In those cases, regulators may permit companies such as BioLineRx to provide special access to investigational medicines outside of a clinical trial setting. These situations are often called expanded access programs, but are also referred to as compassionate use, early access, or emergency use (herein “expanded access”).
How Expanded Access Works
Consistent with applicable laws and regulations, BioLineRx may, at its discretion, provide patients with access to our product candidates through expanded access programs when there is sufficient evidence of the investigational agent’s safety and efficacy to support its use in a particular situation and when other circumstances warrant its use. Because our product candidates have not been fully evaluated for safety and effectiveness, the decision to provide expanded access is a significant one and one that BioLineRx takes very seriously.
At present, we are not planning to offer any expanded access to any of our investigational drug candidates. We do, however, accept requests for such expanded access, given the level of unmet medical need that we see existing in the patient communities we are focusing on. So, while we do not anticipate providing any expanded access, we have not entirely closed off this possibility. And we recognize the potential for this to change as we proceed along our chosen developmental path.
Please refer any questions regarding this policy to MedInfo@biolinerx.com.