ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis
Final Phase I/IIa data shows safety and tolerability, plus efficacy
Bristol, UK - 30th January, 2008, Apitope Technology (Bristol) Ltd.,
the developer of peptide-based therapies for autoimmune diseases and
allergy, announces today final results of a Phase I/IIa clinical
trial of ATX-MS-1467 to treat Multiple Sclerosis (MS). Immunological
analyses showed a significant down regulation of the T-cell response
to the autoantigen (myelin basic protein) whilst the important normal
immune responses were left unchanged.
As previously announced, the therapeutic peptide vaccine was found to
be safe and well tolerated in Secondary Progressive Multiple
Sclerosis (SPMS) patients with no treatment related serious adverse
or adverse events reported.
Although the trial was not designed to show efficacy, there is
preliminary evidence of a positive clinical response to ATX-MS-1467
in two of the six patients. One patient with optic neuritis resulting
from the neuroinflammatory process involved in MS continues to
demonstrate a clinically significant improvement in visual acuity
post treatment. Additionally, a second patient has shown improvement
in the Gd-enhanced MRI scan indicating a reduction in
neuroinflammatory processes in the brain.
"We are extremely pleased with these results in secondary progressive
MS patients. The peptides are very well tolerated in this patient
group", said Dr Keith Martin, CEO of Apitope. "Also, we now have good
indicators that these peptides may be a significant improvement on
current therapies available to patients with MS, a disease with huge
unmet medical need."
The immunological analyses showed a reduction of up to 40% in myelin
basic protein-induced T-cell proliferation one month after the course
of treatment with ATX-MS-1467 while the T-cell response to PPD (a
constituent of the BCG vaccine) was unchanged.
"These preliminary clinical and immunological data are very
encouraging and support the preclinical and scientific evidence on
which this product is based", said Professor David Wraith, CSO of
Apitope and Professor of Experimental Pathology at the University of
Bristol.
Apitope expects to begin a final Phase II trial of ATX-MS-1467 before
the fourth quarter this year with full results expected within 24
months of the trial start. This trial will be designed as a
double-blind placebo controlled study in MS patients with the more
frequently encountered relapsing remitting form of MS.
Along with development of ATX-MS-1467 Apitope is continuing
development of a diagnostic blood test for MS and expects to complete
the clinical validation in patients with all forms of MS in the next
12 months.
ATX-MS-1467, is a vaccine containing four peptides derived from human
myelin basic protein that targets the major histocompatibility
complex (MHC) class II molecule and has been specifically designed
and developed to treat MS patients. The recently completed
ATX-MS-1467 Phase I/IIa open label trial was designed as a dose
escalation study to assess the safety and tolerability with all six
patients receiving five escalating doses given 7 to 14 days apart of
25, 50, 100, 400 and 800 followed by a repeat of the 800 microgram
dose.
ABOUT APITOPE TECHNOLOGY (BRISTOL) LTD
Apitope is a biopharmaceutical company engaged in the research and
development of treatments for allergy and autoimmune diseases. The
Company is developing novel advantaged products representing major
advances in therapy and addressing critical unmet needs that can
revolutionise the treatment of chronic autoimmune and allergic
disorders. Apitope was established at the University of Bristol in
January 2002 by Professor David Wraith and initially funded by Mr
Richard Daniels.
The company has a patented platform technology for the design of
peptide therapeutics (ApitopesTM) to treat autoimmune and allergic
diseases. This novel Apitope technology is based on established
scientific evidence showing that soluble, synthetic peptides can
reinstate tolerance and attenuate pathological immune responses. The
therapy is specifically designed from naturally occurring antigenic
proteins to selectively inhibit the immune system's harmful attack on
the body while preserving the normal immune response to harmful
antigens, such as infections. The unique Apitope peptides function as
tolerogens, exerting their therapeutic effect via an highly selective
immune re-balancing process that, in pre-clinical studies, has been
linked to the induction of IL-10 secreting regulatory T cells.
Behaving as Antigen Processing Independent epiTOPES (ApitopesTM), the
peptides induce tolerance to abnormal immune responses.
The company, initially, is testing the safety and efficacy of
ApitopesTM in multiple sclerosis (MS) patients. Its lead product is
ATX-MS-1467, a peptide vaccine, which up regulates T cells through
the major histocompatibility complex (MHC) class II receptor. The
vaccine is potentially a disease-modifying therapy specifically
designed from a naturally occurring antigenic protein to selectively
inhibit the immune system's harmful attack on the nervous system. The
normal immune response to infection is preserved. The ATX-MS-1467
vaccine is an equal parts mixture of four soluble, synthetic peptides
(ApitopesTM). The company plans to develop ApitopesTM for other
chronic diseases including Type I diabetes, rheumatoid arthritis and
the common allergies.
* Apitope's Phase I/IIa protocol for MS was approved by the MHRA in
February 2007
* The Company is also developing an MS diagnostic, which is based on
its proprietary technology, with a predicted launch date of Q4,
2009
* A peptide vaccine to prevent Factor VIII intolerance is expected to
enter clinical trials in late 2008.
Apitope is backed by The Wellcome Trust, Sulis Seedcorn Fund and
advised by
Innovator Capital.
Further information on the company can be found at:
http://www.apitope.com/
Contact:
Apitope Technology (Bristol) Ltd
Dr. Keith Martin, CEO
+44 117 903 1119
keith.martin@apitope.com
Innovator Capital Limited
Kalam Ali
+44 20 7297 6840
kalam.ali@innovator-capital.com
The press release can be downloaded from the following link: