Apitope Technology (Bristol) Ltd., the developer of peptide-based therapies, has announced the completion of dosing for all six Multiple Sclerosis (MS) patients in a phase I/IIa trial of ATX-MS-1467. The therapeutic vaccine was found to be safe and well tolerated in Secondary Progressive Multiple Sclerosis (SPMS) patients.
Although efficacy was not an endpoint of this trial, one patient, with optic neuritis resulting from the neuroinflammatory process involved in MS, did demonstrate a clinically significant improvement in visual acuity post treatment. This was demonstrated in analysis of the initial visual acuity examination at screening compared to the one month follow up test. Initial screening sight measurements of 6/24 and 6/9 (in right and left eye, respectively) improved to 6/9 (right eye) and 6/6 (left eye) post treatment. The patient's secondary progressive disease had been gradually worsening over the past 5 years.
"This trial has been very successful and clearly shows there are no safety and tolerability issues around ATX-MS-1467", said David Wraith, CSO, Apitope and Professor of Experimental Pathology at the University of Bristol. "Beyond this, one of our patients has shown a remarkable improvement in her eyesight. Since the optic nerve is acutely sensitive to inflammation and optic neuritis is often one of the first symptoms of MS, this early indication of efficacy is very encouraging. It suggests that treatment with ATX-MS-1467 can suppress the inflammation associated with MS," he added. "Now we are excellently positioned to begin proof of concept trials."
"ATX-MS-1467 has been specifically designed and developed to treat MS patients; these results prove the Apitope platform can produce effective clinical compounds," said Dr Keith Martin, CEO, Apitope. "Moreover, in business terms ATX-MS-1467 and the related MS diagnostic, which was recently patented, give us several interesting partnership opportunities."
The 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 µg dose.
The full phase I/IIa results will be reported in the first quarter 2008, following a three-month safety and tolerability examination of each SPMS patient.
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.