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Molecular Medicine SpA Enters Agreement with GlaxoSmithKline Plc for Manufacture of Experimental Gene Therapy for Compassionate Use for ADA-SCID

Friday, 22 Nov 2013 01:01am EST 

Molecular Medicine SpA (MolMed) announced that it has entered into an agreement with GlaxoSmithKline Plc (GSK) under which MolMed will be responsible for the manufacture of GSK's investigational gene therapy for compassionate use in patients with Adenosine Deaminase Deficiency - Severe Combined Immune Deficiency (ADA-SCID) in the potential event that an investigator led named patient compassionate use application is approved. ADA-SCID is a rare and severe form of immune-deficiency, affecting approximately 350 children worldwide, caused by the alteration of a single gene coding for the adenosine deaminase enzyme (ADA). In these patients, the immune system is so severely impaired that it is unable to defend against infectious agents. MolMed previously produced on behalf of Telethon the investigational gene therapy where the correct form of the ADA gene is inserted into the patients' own bone marrow derived stem cells. GSK is continuing the clinical development of the ADA-SCID gene therapy in collaboration with the San Raffaele Telethon Institute for Gene Therapy (HSR-TIGET) from which GSK has in-licensed the rights to develop and commercialize the therapy. Clinical trials testing the gene therapy are complete and for patients lacking suitable therapy referred to San Raffaele Hospital, following ethical approval, GSK will support compassionate use named patient through product manufacture at MolMed.