ATX-MS-1467 completes dosing stage in a Phase I/IIa trial in Multiple Sclerosis patients
Preliminary data shows safety and tolerability, plus efficacy
Bristol, UK - 5th November 2007, Apitope Technology (Bristol) Ltd., the developer of peptide-based therapies, announces 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 patientâ€™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 of 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," noted Dr Keith Martin, CEO of 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 Âµg 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.
ABOUT APITOPE TECHNOLOGY (BRISTOL) LTD
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.
The company has a patented platform technology for the design of peptide therapeutics (ApitopesTM) to treat autoimmune and allergic diseases. This novel Apitope technology is based on established scientific evidence showing that soluble, synthetic peptides can reinstate tolerance and attenuate pathological immune responses. The therapy is specifically designed from naturally occurring antigenic proteins to selectively inhibit the immune system's harmful attack on the body while preserving the normal immune response to harmful antigens, such as infections. The unique Apitope peptides function as tolerogens, exerting their therapeutic effect via an highly selective immune re-balancing process that, in pre-clinical studies, has been linked to the induction of IL-10 secreting regulatory T cells. Behaving as Antigen Processing Independent epiTOPES (ApitopesTM), the peptides induce tolerance to abnormal immune responses.
The company, initially, is testing the safety and efficacy of ApitopesTM in multiple sclerosis (MS) patients. Its lead product is ATX-MS-1467, a peptide vaccine, which up regulates T cells through the major histocompatibility complex (MHC) class II receptor. The vaccine is potentially a disease-modifying therapy specifically designed from a naturally occurring antigenic protein to selectively inhibit the immune system's harmful attack on the nervous system. The normal immune response to infection is preserved. The ATX-MS-1467 vaccine is an equal parts mixture of four soluble, synthetic peptides (ApitopesTM). The company plans to develop ApitopesTM for other chronic diseases including Type I diabetes, rheumatoid arthritis and the common allergies.
- Apitope's Phase I/IIa protocol for MS was approved by the MHRA in February 2007
- The Company is also developing an MS diagnostic, which is based on its proprietary technology, with a predicted launch date of Q4, 2009
- A peptide vaccine to prevent Factor VIII intolerance is expected to enter clinical trials in late 2008.
Apitope is backed by The Wellcome Trust, Sulis Seedcorn Fund and advised by Innovator Capital.
Further information on the company can be found at: http://www.apitope.com/