If you are interested to participate as a study patient in our trials, please discuss with your treating physician if you may be a suitable candidate. For example, participants must have a certain stage of disease, health status, and be eligible to the combination treatment to be enrolled in a study. Your treating physician can revise all the inclusion and exclusion criteria for the study
Lokon Pharma AB is committed bringing innovative medicinal products that are safe and proven effective to patients. At the present time, we are focused on conducting clinical trials needed to gain regulatory approvals in order to make our first investigational drug broadly available as quickly and safely as possible. Participation in one of our clinical trials is the best and preferred route to access our investigational drug and we encourage patients to speak with their physicians to determine potential benefits, risk and eligibility to participate in such clinical trials. A complete listing of clinical trials using Lokon investigational drug can be found at https://clinicaltrials.gov.
Lokon does not provide investigational drugs to patients outside the clinical trial context. However, for patients who previously responded to a Lokon investigational drug within a clinical trial (as defined in the study protocol), and who may benefit from treatment continuation, the treating physician may request expanded access to the Lokon investigational drug. “Expanded Access” refers to the use of an investigational product outside of a clinical trial, for the potential treatment of a serious or life-threatening condition, and different regulations apply in different countries. Hence, a case-by-case evaluation must be completed prior to an expanded access decision for individual patient use by Lokon Pharma. In the US, an Individual Patient Expanded Access (also referred to as single patient) application can be filed by the treating physician. Information on how to apply.
Procedure for initiating an expanded access request to Lokon Pharma:
Patients should speak with their treating physician and discuss potential risks and benefits before seeking expanded access to Lokon’s investigational drugs. If the treating physician determines that expanded access may be of benefit to the patient, the physician should contact Lokon Pharma to make the request on behalf of their patient, using their contact point at Lokon. Physicians should submit a patient-specific study ID from the previous clinical trial using Lokon’s investigational drug and a brief description of the case for which the investigational drug is being requested. Lokon will respond to inquiries within 5 business days from receipt.
Physicians who receive Lokon’s investigational drug for their patients through expanded access must comply with all applicable laws and regulations, contractual obligations, safety reporting required by regulatory agencies and protection of intellectual property.
Posting this policy by Lokon does not guarantee access to an investigational drug for anyindividual patient.