Biotherapeutics
Expanded Access for orBec®
Soligenix, Inc. is collaborating with pharmaceutical and distribution partners around the world to provide orBec® (oral beclomethasone dipropionate) via named patient access programs to people suffering from gastrointestinal Graft-versus-Host disease (GI GVHD), a debilitating and potentially life-threatening condition related to treatment for leukemia and other blood-borne cancers. There is currently no approved treatment for GI GVHD, which afflicts up to 60% of patients who undergo allogeneic hematopoietic stem cell transplantation.
What is orBec®
orBec® is an investigational therapy (i.e., orBec® has not received marketing authorization/regulatory approval in any territory) that has been evaluated in Phase 1, 2 and 3 clinical trials and will be the subject of a confirmatory, Phase 3 study for the treatment of acute GI GVHD. For more information about orBec®, please refer to the Soligenix biotherapeutics page.
What is a named patient access program?
A named patient access program is a mechanism that permits the supply of an unlicensed product to a specific healthcare professional for the treatment of an individual patient. Each country has its own regulations that provide a mechanism to allow access to patients who need these medicinal products. The exact requirements for use vary from country to country.
How can I obtain orBec®?
Healthcare professionals may be able to obtain orBec® via a named patient use program by contacting the appropriate Soligenix corporate partner (see Global page for partners and respective territories along with contact information). For further information regarding the Named Patient Access Program, please contact Adam Rumage, Director of Clinical & Regulatory Operations, at (609) 538-8200, or send an e-mail to accessorbec@soligenix.com.
