Bayhill Therapeutics, Inc. Announces the Successful Clearance of an IND for BHT-3034 for the Treatment of Myasthenia Gravis
3/2/2011 9:12:02 AM
PALO ALTO, Calif.--(BUSINESS WIRE)--Bayhill Therapeutics Inc, a clinical-stage biopharmaceutical company utilizing its proprietary BHT-DNA™ platform to develop novel and targeted autoimmune and immune-mediated disease treatments, today announced the successful clearance of an IND with the US FDA for BHT-3034, a disease-modifying DNA plasmid vaccine immunotherapy for patients with the autoimmune neuromuscular junction disease myasthenia gravis. The IND was filed based on promising preclinical efficacy results showing significant disease severity attenuation and anti-acetylcholine receptor autoantibody reduction, as well as GLP toxicology studies showing no evidence of toxicity or immunogenicity. The IND also included a phase I/II dose escalation clinical study to treat up to 40 subjects with myasthenia gravis with 12 weekly doses of BHT-3034 intramuscularly.