RTL 1000 phase 1 results
Posted: Mon Sep 14, 2009 6:13 am
Artielle ImmunoTherapeutics Announces Positive Results of Phase 1 Multiple
Sclerosis Trial
Results Presented at 13th Congress of the European Federation of Neurological
Societies in Florence, Italy
PORTLAND, Ore., Sept. 14 /PRNewswire/ -- Artielle ImmunoTherapeutics, a
clinical stage biopharmaceutical company announced today the presentation of
"Results of a Phase 1 safety study of RTL1000, a recombinant T-Cell receptor
ligand specific for an immunodominant MOG peptide, in multiple sclerosis." The
results were presented yesterday by one of Artielle's founding scientists,
Arthur Vandenbark, Ph.D., at the Congress of the European Federation of
Neurological Societies in Florence, Italy.
The presentation showed that this Phase 1 Study met its primary objective,
which was to evaluate the safety profile and determine the maximum tolerated
dose (MTD) of a single IV dose of RTL1000. Secondary objectives of the study
were also met; these were to determine the pharmacokinetic profile of RTL1000
and assess immunologic parameters in a subset of Multiple Sclerosis (MS)
patients. This was a first-in-human, double-blind, placebo controlled trial
that enrolled 34 subjects with relapsing remitting and secondary progressive
MS at six centers in the United States. All subjects were followed for
clinical and MRI changes, pharmacokinetics and cytokine levels in plasma and
blood mononuclear cells.
According to Dr. Arthur Vandenbark, "This trial demonstrated that RTL1000 was
safe and did not exacerbate MS disease activity at any of the tested doses.
Although this study was not designed to assess efficacy, immunological data in
a subgroup of patients indicated RTL1000 was biologically active."
"The successful completion of this Phase 1 study represents a major milestone
in the potential treatment of this devastating disease and in the development
of our proprietary platform technology," said Dr. Al Ferro, President and CEO
of Artielle ImmunoTherapeutics, Inc. "We plan to move aggressively to bring
these novel, first-in-class products to the market place."
Worldwide, multiple sclerosis (MS) is thought to affect more than 2.5 million
people. MS is a chronic autoimmune disease caused when T cells, part of the
body's immune system, attack the central nervous system (CNS), which is made
up of the brain, spinal cord and optic nerves. Symptoms may be mild, such as
numbness in the limbs, or severe, such as paralysis or loss of vision. In MS,
activation of these T cells triggers the release of inflammatory cytokines
that lead to the destruction of the myelin, the fatty substance that surrounds
and protects the nerve fibers in the central nervous system. When any part of
the myelin sheath or nerve fiber is damaged or destroyed, nerve impulses
traveling to and from the brain and spinal cord are distorted or interrupted,
producing the variety of symptoms that can occur. As demonstrated in animal
studies, RTL1000 inhibits the activation of myelin-reactive T cells,
preventing the release of inflammatory cytokines and causing the release of
anti-inflammatory cytokines. Artielle has also shown in models of MS that
animals treated with RTL1000 demonstrate repair of the myelin sheath.
Sclerosis Trial
Results Presented at 13th Congress of the European Federation of Neurological
Societies in Florence, Italy
PORTLAND, Ore., Sept. 14 /PRNewswire/ -- Artielle ImmunoTherapeutics, a
clinical stage biopharmaceutical company announced today the presentation of
"Results of a Phase 1 safety study of RTL1000, a recombinant T-Cell receptor
ligand specific for an immunodominant MOG peptide, in multiple sclerosis." The
results were presented yesterday by one of Artielle's founding scientists,
Arthur Vandenbark, Ph.D., at the Congress of the European Federation of
Neurological Societies in Florence, Italy.
The presentation showed that this Phase 1 Study met its primary objective,
which was to evaluate the safety profile and determine the maximum tolerated
dose (MTD) of a single IV dose of RTL1000. Secondary objectives of the study
were also met; these were to determine the pharmacokinetic profile of RTL1000
and assess immunologic parameters in a subset of Multiple Sclerosis (MS)
patients. This was a first-in-human, double-blind, placebo controlled trial
that enrolled 34 subjects with relapsing remitting and secondary progressive
MS at six centers in the United States. All subjects were followed for
clinical and MRI changes, pharmacokinetics and cytokine levels in plasma and
blood mononuclear cells.
According to Dr. Arthur Vandenbark, "This trial demonstrated that RTL1000 was
safe and did not exacerbate MS disease activity at any of the tested doses.
Although this study was not designed to assess efficacy, immunological data in
a subgroup of patients indicated RTL1000 was biologically active."
"The successful completion of this Phase 1 study represents a major milestone
in the potential treatment of this devastating disease and in the development
of our proprietary platform technology," said Dr. Al Ferro, President and CEO
of Artielle ImmunoTherapeutics, Inc. "We plan to move aggressively to bring
these novel, first-in-class products to the market place."
Worldwide, multiple sclerosis (MS) is thought to affect more than 2.5 million
people. MS is a chronic autoimmune disease caused when T cells, part of the
body's immune system, attack the central nervous system (CNS), which is made
up of the brain, spinal cord and optic nerves. Symptoms may be mild, such as
numbness in the limbs, or severe, such as paralysis or loss of vision. In MS,
activation of these T cells triggers the release of inflammatory cytokines
that lead to the destruction of the myelin, the fatty substance that surrounds
and protects the nerve fibers in the central nervous system. When any part of
the myelin sheath or nerve fiber is damaged or destroyed, nerve impulses
traveling to and from the brain and spinal cord are distorted or interrupted,
producing the variety of symptoms that can occur. As demonstrated in animal
studies, RTL1000 inhibits the activation of myelin-reactive T cells,
preventing the release of inflammatory cytokines and causing the release of
anti-inflammatory cytokines. Artielle has also shown in models of MS that
animals treated with RTL1000 demonstrate repair of the myelin sheath.