Apitope Completes Recruitment into its Clinical Trial of ATX-MS-1467 in
BRISTOL, England & HASSELT, Belgium -- November 26, 2012
Apitope, the European drug discovery and development company focused on
treating the underlying cause of autoimmune diseases, today announced
completion of recruitment into its second Phase I clinical trial of
ATX-MS-1467 in patients with multiple sclerosis (MS). Receipt of the first
dose of study treatment by the last patient to be recruited prompted an
undisclosed clinical milestone payment from Merck Serono, a division of Merck,
Germany, with whom Apitope is developing ATX-MS-1467.
ATX-MS-1467 is a novel treatment that was developed with the aim of working
with the immune system to treat the underlying cause of disease rather than
just treating the symptoms or suppressing the entire immune system, and thus
restore immunological balance.
ATX-MS-1467 has already completed successfully a Phase I clinical trial in six
patients with secondary progressive MS (SPMS). Based on these encouraging
preliminary results, a second Phase I clinical trial has been implemented to
assess the safety of ATX-MS-1467 as well as biological parameters in a group
of 40patients with relapsing MS.
The clinical trial is being carried out at two hospitals in the UK, as well as
12 clinics in Russia. Dosing of ATX-MS-1467 is expected to be complete by the
end of 2012.
Dr. Jeremy Chataway, Chief Investigator for the trial, from the National
Hospital for Neurology and Neurosurgery in London commented: “ATX-MS-1467
could serve as a treatment option for patients with multiple sclerosis so this
is an important step in the current trial.”
The primary endpoint of the trial is safety and tolerability, as assessed by
adverse effects and MRI scans, while secondary endpoints are designed to
provide an insight into the immunological activity of this investigational
treatment. A range of doses of ATX-MS-1467 is being administered either
intra-dermally or sub-cutaneously once every two weeks for 16 weeks, with a
further 24 weeks of post-treatment follow up.
Apitope is developing ATX-MS-1467 with Merck Serono, a market leader in the
treatment of MS. Under the terms of the agreement between the two companies,
Apitope is responsible for this Phase I clinical trial of ATX-MS-1467. Merck
Serono will be responsible for all development activities from the beginning
of Phase II clinical trials.
Dr. Keith Martin, CEO of Apitope added: “ATX-MS-1467 is the first therapeutic
developed from Apitope’s innovative technology platform and we are excited to
have reached this key milestone for our partners. We expect that the results
of this trial in patients with relapsing MS will build on the positive data
from our first study.”
Apitope International NV, based in Belgium and the UK, is a world-class drug
developer of immunotherapies for the treatment of autoimmune and allergic
diseases, including multiple sclerosis, factor VIII intolerance, uveitis and
Graves’ disease. The Company has a patented discovery platform which enables
selection of disease-modifying peptide therapies for the autoimmune/allergic
disease of interest; and has already generated a pipeline of seven programmes
in clinical and preclinical development, of which the lead programme in
multiple sclerosis is partnered with Merck Serono. The discovery engine
selects Apitopes™ - Antigen Processing Independent epiTOPES. Apitopes are
soluble, synthetic peptides from the human sequence which can selectively
suppress abnormal immune responses and reinstate the normal immune balance.
Stakeholders in the Company include the Wellcome Trust, LRM, Vesalius
Biocapital and the US MS charity, Fast Forward. For more information on the
Company, please visit: www.apitope.com.
About Merck Serono
Merck Serono is the biopharmaceutical division of Merck KGaA. With
headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150
countries to help patients with cancer, multiple sclerosis, infertility,
endocrine and metabolic disorders as well as cardiovascular diseases. In the
United States and Canada, EMD Serono operates as a separately incorporated
subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription
medicines of both chemical and biological origin in specialist indications. We
have an enduring commitment to deliver novel therapies in our core focus areas
of neurodegenerative diseases, oncology and rheumatology.
Merck is a global pharmaceutical and chemical company with total revenues of
€10.3 billion in 2011, a history that began in 1668, and a future shaped by
more than 40,000 employees in 67 countries. Its success is characterized by
innovations from entrepreneurial employees. Merck's operating activities come
under the umbrella of Merck KGaA, in which the Merck family holds an
approximately 70% interest and free shareholders own the remaining
approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated
and has been an independent company ever since.
For more information, please visit www.merckserono.com or www.merckgroup.com
ATX-MS-1467 consists of four synthetic peptides that mimic naturally occurring
peptides derived from human Myelin Basic Protein (MBP), a key autoantigen in
multiple sclerosis. ATX-MS-1467 has been designed from naturally occurring MBP
fragments and is intended to selectively inhibit the immune system's harmful
attack on the protective myelin sheath surrounding the nervous cells while
preserving the normal immune response to any harmful antigens, such as
MS is a chronic, inflammatory condition of the nervous system and is the most
common, non-traumatic, disabling neurological disease in young adults, with
most sufferers developing the disease between the ages of 20 and 40 years. The
World Health Organization estimates that up to 2.5 million people suffer from
MS worldwide with women affected 1.8times more frequently than men. While
symptoms can vary, the most common symptoms of MS include blurred vision,
numbness or tingling in the limbs and problems with strength and coordination.
MS develops as a result of damage to the myelin sheath of the nerves which
interferes with their normal function and leads to loss of muscle control. MS
can follow various patterns of disease progression. Most patients initially
have a relapsing form of the condition, which is characterized by
unpredictable relapses followed by periods of months to years of remission.
Approximately two-thirds of patients with relapsing disease go on to develop
secondary progressive MS, in which progressive neurologic decline continues
between acute attacks without any periods of remission.
For further information:
Apitope International N.V.
Dr. Keith Martin, CEO
+44 117 370 7720
For media enquiries:
Melanie Toyne Sewell / Gemma Howe
+44 20 7866 7860
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