Enzo Biochem, Inc. announced that, following filing
of a investigational new drug (IND) application with the FDA, its Enzo
Therapeutics division is commencing a clinical trial of Optiquel(TM) , 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.
Optiquel(TM) 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(TM) 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(TM), 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(TM) 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(TM), 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."
Source: Enzo Biochem, Inc.
