Oct 4 2010
Enzo Biochem, Inc. (NYSE: ENZ), announced today that, following filing of a investigational new drug (IND) application with the FDA, its Enzo Therapeutics division is commencing a clinical trial of Optiquel™ , the Company's proprietary oral therapeutic for chronic non-infectious uveitis. The trial is designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up and is being conducted by the National Institute of Health's National Eye Institute (NEI). Robert Nussenblatt, MD, Chief of NEI's Laboratory of Immunology, will serve as Principal Investigator.
“We are pleased to announce the initiation of this clinical trial, and that it will be performed at the National Eye Institute”
Optiquel™ has been awarded orphan drug status in the European Union and a similar designation may be applied for in the US. Enzo owns the exclusive rights to both US and international patents claiming the use of this compound for the treatment of uveitis. An investigator-initiated clinical trial of Optiquel™ in Germany demonstrated a therapeutic effect with no treatment-related side effects.
Uveitis is a collective term for a variety of ophthalmic conditions that result in chronic inflammation of the eye involving the uvea, which lies between the outermost and innermost layers of the eye. Uveitis occurs most frequently in relatively young people, ages 20 to 50. A recent study estimated that more than 280,000 people in the United States are affected by uveitis each year, and that the disease is associated with 30,000 cases of blindness annually. It has been estimated that 10-22% of new cases of blindness in the United States result from this disease.
Patients with chronic autoimmune uveitis often require immunosuppressive treatment for an extended period of time. Furthermore, immunosuppressive therapy is frequently associated with side effects, including glaucoma and cataracts that limit the duration and intensity of treatment.
Optiquel™, by contrast, has been designed as a novel and specific immune modulator that utilizes a highly specific down-regulation of the uveitis autoimmune response by oral treatment with an antigen that is very nearly identical to the offending antigen. This tolerogenic approach with Optiquel™ is based on Enzo's proprietary oral immune regulation platform, a platform that has been studied extensively across a number of clinical indications.
"We are pleased to announce the initiation of this clinical trial, and that it will be performed at the National Eye Institute," said Elazar Rabbani, Ph.D., Chairman and CEO of Enzo Biochem. "Chronic non-infectious uveitis is currently treated with steroids and other general immune suppressive therapy, often producing serious and damaging side effects. Optiquel™, if it meets its endpoints of reducing the need for high doses of steroid treatment in order to reduce symptoms and improve visual acuity, would represent a significant step forward in the treatment of this affliction."
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