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Therapeutic Areas

LaTherapeutic Areastona Life Sciences, Inc. is focused on developing orphan drugs for immune-mediated diseases. Oralgam™ has been granted Orphan Drug Status by the FDA for Juvenile Idiopathic Arthritis (JIA), Dermatomyositis, and autistic enterocolitis.

The Phase II study in JIA patients did not meet the primary endpoint at the end of 8 weeks; but, children remaining on oral immunoglobulin (IgG) during the open label extension of the Phase II study continued to improve in multiple measures of disease activity.

A prospective, open label study in children with autism showed evidence that oral immunoglobulin can be safely used to treat chronic gastrointestinal disturbances associated with autism.

Oralgam is a registered trademark of Latona Life Sciences, Inc.

References:

  • Weisbart, R.H., Ho, G.Y., Park, C.H.: Beneficial effects of oral immunoglobulin in rheumatoid arthritis. J. Clinical Rheum., 1:135, 1995.
  • Schneider, C.K.; Melmed, R.D.; Enriquez, F.J.; Barstow, L.E.; Ranger-Moore, J.; Ostrem, J.A.: Oral Human Immunoglobulin for Children with Autism and Gastrointestinal Dysfunction: A Prospective, Open-Label Study. J. Autism Dev Disord (2006).