Oral Treatment
- From: "Cowboy" <msbuckaroo@xxxxxxxxxxx>
- Date: Fri, 29 Jul 2005 19:12:07 -0600
Copyright 2005 Drug Week via NewsRx.com & NewsRx.net
Drug Week
July 29, 2005
IND submitted to U.S. FDA for oral treatment of relapsing multiple sclerosis
Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech AB (ACTI.ST)
announced the submission of an investigational new drug application (IND) to
the U.S. Food and Drug Administration (FDA) to initiate a clinical trial in
the U.S. with laquinimod to assess drug-drug interaction.
Based on the results of this study and of the ongoing phase 2b study in
Europe, the phase 3 clinical program to confirm the efficacy and safety of
laquinimod in relapsing forms of MS, is planned to start in 2006.
Laquinimod is an orally administered immunomodulatory substance, developed
by Active Biotech and recently licensed to Teva.
Laquinimod has the potential to be the first orally administered disease
modifying treatment for multiple sclerosis, both as a single agent therapy
and in combination with Copaxone.
A double-blind, placebo-controlled multi center phase 2b clinical study is
currently on-going in several European countries in which the effects of
laquinimod, administered orally, once-daily, at dose levels of 0.3 and 0.6
mg/day, are compared to those of placebo over 9 months of treatment.
Laquinimod is an immunomodulatory substance developed as an orally
bio-available disease modifying treatment of MS. Laquinimod is the lead
candidate drug identified from Active Biotech's SAIK research program, in
which the safety/activity ratio has been optimized.
In a completed randomized, double-blind, placebo-controlled, multi-center
phase 2 trial, 209 patients received either laquinimod, at dose levels of
0.1 or 0.3 mg/day, or placebo, orally, once daily for 24 weeks. Laquinimod,
at the dose of 0.3 mg/day, reduced disease activity (as measured by MRI) by
44%. In a sub-group of patients with active MRI brain lesions prior to
treatment initiation, the same dose of laquinimod reduced disease activity
by 52%. In this study, laquinimod demonstrated a very favorable safety
profile, suitable for long-term treatment (Neurology, 2005;64:6,987).
Multiple sclerosis (MS) is a chronic, progressive disease of the central
nervous system. It is the most common neurological disease causing
disability in young adults. It has been described as an autoimmune disease
because it is one of many diseases in which the immune system attacks
healthy areas of the body as if they were foreign. In MS, these attacks are
aimed at the central nervous system. The central nervous system is made up
of nerves covered by a substance called myelin, which is similar to
insulation protecting electrical wires because it surrounds and protects
nerve fibers. When myelin or the nerve fiber is destroyed or damaged, the
nerves cannot send electrical impulses to and from the brain, causing the
onset of MS symptoms.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is a large
generic pharmaceutical company. The company develops, manufactures and
markets generic and human pharmaceuticals and active pharmaceutical
ingredients. Close to 90% of Teva's sales are in North America and Europe.
Active Biotech AB is a biotechnology company focusing on research and
development of pharmaceuticals in the area of autoimmune/inflammatory
diseases and cancer.
This article was prepared by Drug Week editors from staff and other reports.
Copyright 2005, Drug Week via NewsRx.com.
--
For this and many more articles, see Paul Jones' website at
http://www.mult-sclerosis.org/
.
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