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SYS-CON UK Authors: Salvatore Genovese, Jamie Matusow

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Apitope Completes Recruitment into its Clinical Trial of ATX-MS-1467 in Multiple Sclerosis

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 40 patients 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.”

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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 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

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 1.8 times 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.

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