Revimmune for Autoimmune Disease
31 Jul 2007
Autoimmune diseases afflict more than 8 million people in the U.S.
and impact on virtually every medical specialty.
TAMPA, FL, USA | July 31, 2007 | Revimmune uses an ultra-high
intensity, short-course of an intravenous formulation of an approved
drug (cyclophosphamide)
patient's immune system, thereby eliminating the autoimmunity,
whereas current therapies including oral cyclophosphamide are used
chronically to try to suppress the inflammation of autoimmunity.
Based on long-term follow-up showing complete remissions, there is
substantial evidence that Revimmune has the potential to cure cases
of severe refractory autoimmune diseases such as aplastic anemia and
myasthenia gravis. Accentia's lead indication for Revimmune is
multiple sclerosis (MS).
Autoimmune Diseases Afflict Millions of Patients
Autoimmune diseases afflict more than 8 million people in the U.S.
and impact on virtually every medical specialty. While many
autoimmune disorders (e.g., vitiligo, thyroiditis, pernicious anemia)
are relatively indolent and easily managed, severe cases of systemic
lupus erythematosus, rheumatoid arthritis, aplastic anemia, multiple
sclerosis, etc., can cause severe morbidity and even mortality.
To date, more than 30 neurologic diseases have been recognized either
to be caused primarily by autoimmune mechanisms, or to have important
autoimmune components. Although many of these diseases can be treated
clinically by currently available conventional immunosuppressive
regimens, important problems remain: some patients are refractory to
standard immunotherapy, and others respond only partially.
In nearly all cases, immunotherapy must be continued indefinitely,
maintaining an impaired immune system, and often resulting in
cumulative adverse side effects. Despite this, the vast majority of
patients on conventional immunomodulatory treatment for MS continue
to accrue disability.
Revimmune Therapy for Autoimmune Disease
Based on long-term follow-up showing complete remissions, there is
substantial evidence that Revimmune has the potential to cure cases
of severe refractory autoimmune diseases such as aplastic anemia and
myasthenia gravis. Accentia's lead indication for Revimmune is
multiple sclerosis (MS).
Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at
the Johns Hopkins University School of Medicine, Revimmune works by
temporarily eliminating peripheral immune cells, including the immune
cells causing the autoimmunity, while selectively sparing the stem
cells in the bone marrow. Investigators at Hopkins discovered that
stem cells uniquely have high levels of a particular protective
enzyme that can be measured in advance of therapy, which makes them
impervious to Revimmune, and allows the surviving stem cells to give
rise to the new immune system over 2 to 3 weeks. The newly
reconstituted peripheral immune system typically lacks the
misdirected immunity to self-antigens, which is characteristic of
autoimmune diseases.
Studies at Johns Hopkins University School of Medicine by Dr. Jones,
Dr. Brodsky, and colleagues have demonstrated the potential benefits
of Revimmune in a variety of autoimmune diseases.
According to information from the National Multiple Sclerosis
Society, there are approximately 400,000 people in the US with
Multiple Sclerosis. For the clinical course, 85% of patients are in
the category of relapsing-remitting
et al.(1), "How common are the 'common' neurologic disorders?," the
annual incidence of Multiple Sclerosis in the U.S. was approximately
4.2 new cases per 100,000 population in 2005.
Revimmune Therapy for Multiple Sclerosis:
Revimmune treatment of 20 Multiple Sclerosis patients has resulted in
the following successful outcomes in 2 published studies from C.
Krishnan, D. Kerr et al.(2) and D. Gladstone et al.(3):
-- All patients have had a reduction or elimination of new and
enhancing lesions on the MRI
-- No patient has had a clinical exacerbation following treatment and
most patients have had a reduction in EDSS and an improvement in the
MSFC following treatment
-- During follow-up, no patients increased their baseline EDSS scores
by more than 1.0
-- No patient had a new lesion on brain magnetic resonance imaging;
no patient showed any enhancing lesions
Systemic Lupus
Investigators have treated 40 severe systemic lupus erythematosus
(SLE) patients in clinical studies with Revimmune. A significant
improvement in the SLE diseases activity index was observed. There
were 5 durable complete responses. Among severe, refractory cases,
approximately 80% of patients treated had a complete or partial
response when treated.
Myasthenia Gravis:
Using Revimmune, investigators have treated 11 patients with
myasthenia gravis refractory to conventional immunosuppressive
therapy. Nine of the subjects in the study markedly improved, and
have returned to full activity.
Aplastic Anemia
Acquired severe aplastic anemia (SAA) is a severe, life-threatening
autoimmune disease wherein a patients' immune system mistakenly
attacks their own stem cells in their bone marrow. Most SAA patients
will die within a year of diagnosis. Investigators have treated 75
SAA patients with Revimmune and the majority of patients have
achieved a complete remission without the need of other
immunosuppressive agents.
Autoimmune Hemolytic Anemia
Investigators have treated 10 patients with refractory autoimmune
hemolytic anemia. After Revimmune treatment, all patients responded
and became transfusion independent. There were 6 patients that
achieved complete remission and 3 patients that achieved partial
remission. There were no relapses at a median follow-up of 15 months
and 7 of the 9 patients were able to discontinue steroids.
Experience with other autoimmune diseases
Investigators have reported favorable case experience with refractory
scleroderma, acquired pemphigus, rheumatoid arthritis, and Crohn's
Disease.
References
(1)"How common are the 'common' neurologic disorders?;" D. Hirtz, D.
J. Thurman, K. Gwinn-Hardy, M. Mohamed, A. R. Chaudhuri, and R.
Zalutsky; Neurology 2007 68: 326-337.
(2)"High-Dose Cyclophosphamide in the Treatment of Aggressive
Multiple Sclerosis;" Chitra Krishnan, Daniel Drachman, Justin
McArthur, David Irani, Avindra Nath, Carlos Pardo-Villamizar, David
Yousem, Robert Brodsky, Peter Calabresi, Douglas A. Kerr, Baltimore,
MD. AAN Abstract (P01.072); April 4, 2006.
(3)"High-Dose Cyclophosphamide for Moderate to Severe Refractory
Multiple Sclerosis;" Douglas E. Gladstone, MD; Kenneth W. Zamkoff,
MD; Lauren Krupp, MD; Robert Peyster, MD; Patrick Sibony, MD;
Christopher Christodoulou, PhD; Emily Locher, RN; Patricia K. Coyle,
MD Arch Neurol/Vol 63, Published Online August 14, 2006.
SOURCE: Accentia BioPharmaceuticals
http://www.pipeline
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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