Apitope Announces Positive Results from Clinical Trial of ATX-MS-1467 in Relapsing Multiple Sclerosis

  Apitope Announces Positive Results from Clinical Trial of ATX-MS-1467 in
  Relapsing Multiple Sclerosis

Business Wire

BRISTOL, Englad & HASSELT, Belgium -- September 3, 2013

Apitope, the drug discovery and development company focused on treating the
underlying cause of autoimmune diseases, today announced completion with
positive results of its second Phase I clinical trial of ATX-MS-1467.
Examination of the MRI results (new Gd and total Gd enhancing lesions)
demonstrated a significant decrease in the number of contrast-enhancing brain
lesions (CEL) in patients with relapsing multiple sclerosis treated by
intradermal injection of ATX-MS-1467. The same effect was not seen in the
subcutaneously dosed group. These encouraging results will now need
confirmation in appropriate Phase II trials.

Completion of the study together with these positive MRI-based data allows
Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt,
Germany, with whom Apitope is developing ATX-MS-1467, to develop plans for
Phase II onwards.

Dr. Keith Martin, CEO of Apitope stated: “We are pleased to have successfully
completed a challenging clinical trial with positive results. The results of
this trial in patients with relapsing MS continue to build on the positive
data from our first study and provide further clinical support for the Apitope
approach to the treatment of serious autoimmune conditions.”

Prof David Wraith, Apitope’s CSO and Founder added: ”Antigen specific
immunotherapy is designed to correct the immunological imbalance that causes
autoimmune disease without inducing the non-specific immune suppression that
so frequently causes unacceptable side effects. Up to now this approach has
been shown to be highly effective in experimental models but has been slow to
progress into the clinic. It is, therefore, a major step forward that the
approach is proving to be so well tolerated with early signs of potential
efficacy, as evidenced by the results of Apitope’s two clinical trials in MS.”

ATX-MS-1467 is a potentially 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, restoring immunological balance.

It 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 completed to assess the
safety of ATX-MS-1467, as well as biological parameters, in a total of
43patients with relapsing MS.

The primary endpoint of the recently completed trial was safety and
tolerability, as assessed by adverse effects and MRI scans, as well as
secondary endpoints to identify early signs of efficacy. Review of the MRI
data showed a significant decrease in new lesions; an early indicator of
potential efficacy.

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 parties,
Apitope was responsible for this Phase I clinical trial of ATX-MS-1467. Merck
Serono will be responsible for all development activities going forward from
the beginning of Phase II clinical trials.

                                    -ends-

About Apitope

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.

About Merck

Merck is a leading pharmaceutical, chemical and life science company with
total revenues of € 11.2 billion in 2012, a history that began in 1668, and a
future shaped by approx. 38,000 employees in 66 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

About ATX-MS-1467

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
infections.

About MS

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.

Contact:

Apitope International N.V.
Dr. Keith Martin, CEO
+44 117 370 7720
keith.martin@apitope.com
or
For media enquiries:
College Hill
Melanie Toyne Sewell / Gemma Howe
+44 20 7866 7860
apitope@collegehill.com
 
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