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November 28, 2007

Immunosyn Gets the Go-Ahead to Manufacture Its First Therapeutic for U.K. Clinical Trials

  • Biozyme Laboratories received approval to import base material and manufacture Immunosyn’s preclinical compound for use in clinical trials in the U.K. SF-1019 has been shown to reduce symptoms of a range of demyelinating conditions of the peripheral nervous system (PNS), according to Immunosyn.

    The license approvals currently granted by the MHRA include a ‘Manufacturer's Authorisation–Investigational Medicinal Products’ as well as ‘Manufacturer's/Importer's Licence’ for manufacturing investigational medicinal products for use in Phase I, II, and III studies. If a company successfully completes these trials it can apply for a full license to distribute throughout the EU.

    SF-1019 is part of a new class of therapeutics made from mammalian cells, Immunosyn reports. As an isolated compound, SF-1019 comprises low molecular weight lipo-peptides  Research suggests that it has additional developmental potential as a treatment for multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, reflex sympathetic dystrophy syndrome, and other autoimmune and neurological disorders.