Apitope Starts New Clinical Trial Of Its Investigational Multiple Sclerosis Treatment Bristol, UK / Hasselt, Belgium – 18 May 2010: Apitope, the European biotech company developing therapeutic peptides to treat autoimmune and allergic diseases, today announced the start of its second Phase I clinical trial of ATX-MS-1467, in patients with Multiple Sclerosis (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. 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.
ATX-MS-1467, an investigational peptide-based therapeutic derived from Apitope’s proprietary technology platform, has already completed successfully a Phase I clinical trial in six patients with secondary progressive MS (SPMS). This new Phase I study aims to build on the results from the initial study and investigates safety and proof-of-principle of ATX-MS-1467 in 40 patients with relapsing forms of MS (RMS).
The clinical trial will be carried out at up to ten sites across the UK.
Dr. Jeremy Chataway, Chief Investigator for trials, of the National Hospital for Neurology and Neurosurgery in London commented: “I am excited to work with Apitope on the clinical trials of ATX-MS-1467. This has the potential to serve as a treatment option for patients with multiple sclerosis.”
The primary end point of the trial is safety and tolerability but secondary end points are designed to provide proof of principle. ATX-MS-1467 will be administered either intra-dermally or sub-cutaneously once every two weeks for 16 weeks, with a further 24 weeks of follow up.
Apitope is developing ATX-MS-1467 with Merck Serono, one of the leading pharmaceutical companies in the treatment of MS. Under the terms of the agreement between the two companies, Apitope is responsible for all Phase I development of ATX-MS-1467. Merck Serono will take over development of the compound at 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 this trial builds on the positive results in our first study.”
