Expanded Access Policy

Light Sciences Oncology, Inc. (“LSO”) is a biotechnology company focused on the development of Talaporfin Sodium for the treatment of Benign Prostatic Hyperplasia (BPH) and cancer. A crucial step in the development of LSO’s investigational new drug is to conduct clinical trials, which assess the safety and efficacy of the products under development. LSO uses the data it collects from clinical trials to support marketing applications to FDA and other regulatory bodies to gain approval and provide access to its products on a widespread basis.

What is expanded access? 
Through expanded access, sometimes also referred to as compassionate use, patients may be able to access investigational new drugs outside of the clinical trial context. FDA will typically facilitate expanded access to investigational products for patients with serious or life-threatening conditions when there is a lack of adequate therapeutic alternatives. Unlike the use of an investigational new drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to gather data on safety and effectiveness.

What is LSO’s policy on expanded access? 
LSO believes the best way to access our investigational products is through participation in one of our clinical trials. We believe that access to investigational therapies should be limited to controlled clinical trials until such time as the safety, tolerability and effectiveness of a therapy has been determined and confirmed by regulatory authorities. Pre-approval access outside of a controlled clinical trial may interfere with the conduct of our ongoing trials and may also disrupt the progress of our development programs, which would, in turn, delay access to many other patients in need.

LSO has no ongoing clinical trials and therefore will not accept expanded access requests at this time. This policy is subject to change at the discretion of the company and this webpage will be updated should there be a policy change.

How can I get more information? 
For more information on clinical triials see https://clinicaltrials.govSearch "Talaporfin Sodium” to find Light Science Oncology clinical trials that may be recruiting. If you are a healthcare professional and would like more information on Light Sciences Oncology’s investigational products, please send an inquiry t
info@lsoncology.com.