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Daval International Limited Release: Open Label Clinical Study Results of AIMSPRO® in the Treatment of Progressive MS Suggest the Drug Stops Disease Progression and May Have Some Restorative Effects



6/3/2013 12:00:42 PM

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Eastbourne, UK – Daval International Limited recently presented a poster at The 2013 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Fifth Cooperative Meeting with Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) in Orlando. The poster, entitled “Clinical benefits reported with AIMSPRO® treatment in progressive multiple sclerosis: open-label observations”, was presented by Dr Christopher Moore from Queen Alexandra Hospital, Department of Clinical Neurophysiology, and the University of Portsmouth, UK. The encouraging results contained in this poster further underscore AIMSPRO’s broad potential as a novel therapeutic agent to treat a number of autoimmune, inflammatory and neurodegenerative diseases.

Dr. Moore presented data from a centralised retrospective analysis of clinical outcomes from 154 patients with confirmed progressive multiple sclerosis (the majority having the secondary progressive form of the disease) with a mean disease duration of 13.6 years and no preceding relapse within 1yr recorded. Patients were treated with subcutaneous injections (1ml per dose) of hyperimmune caprine sera (AIMSPRO®) over a prolonged period of time (maximum 3 years). The analysis is based on self and physician-reported clinical efficacy measures in the 140 patients with documented follow-up/assessments. All clinical improvements, observed or reported were scored in alignment with the expanded disability status score (EDSS) ‘equivalent’, an estimate of the change in the numerical scale that might be expected had formal clinical grading been undertaken prospectively. A +2 improvement would likely reduce a patient’s symptom score by an EDSS of 0.5. More than one +1 improvement would be needed for a similar overall change. Changes in the 8 areas of sensory/pain, motor, bladder, ataxia, sleep, vision, energy, and ‘other’ were scored.

The results of the analysis revealed that the treatment was both safe and well tolerated. In the study, 100 patients had clear improvement in > 2 functional areas (motor and sensory/pain) and as such were likely to have a change of at least -0.5 in their EDSS score. 122 patients showed clinical benefit in > 1 areas. 16 patients reported no overall benefit, 2 patients showed overall worsening by 1 point in 1 area. These clinical observations suggest that AIMSPRO® therapy stopped the decline in progressive MS and may have a restorative effect in multiple clinical areas.

Professor Syed Haq, Chief Medical & Scientific Officer at Daval International and co-author of the poster, commented at the meeting, "The findings of this open-label study are very encouraging for the future development of a medication that could address secondary progressive multiple sclerosis, which at present has no approved treatment. For an efficacy signal to emerge with a therapeutic for SPMS implies that the drug must be concomitantly modulating a number of biochemical pathways. These include perturbation of inflammation, repair of damaged neurons and neurogenesis. Thus the results from this study further underscore AIMSPRO’s broad potential as a novel therapeutic agent to treat a number of autoimmune, inflammatory and neurodegenerative diseases”

The abstract of the poster is available on the Meeting website:

https://cmscactrims.confex.com/cmscactrims/2013/webprogram/Paper1918.html

The poster is available for download on the Daval International website, www.davalinternational.com

The CMSC annual meeting brings together healthcare professionals and researchers involved in MS clinical care or research who are committed to improving the lives of people with MS. The goal of the Annual Meeting is to provide the most up-to-date information impacting all facets of MS patient care.

For further information please contact:

Daval International Ltd

James Shotton +1 303 588 5881 or +44 (0)7739 648401

Chief Executive

NM Rothschild

Julian Hudson +44 (0) 20 7280 5000

FTI Consulting

Julia Phillips / Matthew Cole/ Simon Conway +44 (0)20 7831 3113

About AIMSPRO®

AIMSPRO® (Hyperimmune Caprine Sera, HICS) is a proprietary, purified, protein–multi-peptide conjugate complex being developed as a novel, first-in-class biological treatment for a number of immune diseases where regulation and stabilisation of the immune system is required. It is believed that the drug has a unique mechanism of action that supports its broad potential application in neuro-degenerative diseases. AIMSPRO has been granted a Specials License by the UK's MHRA and is also available in Australia under Categories A and B of the TGA's Special Access Scheme.

About Daval International Limited

Daval International Limited (“Daval International” or “Daval”), is a UK based biotechnology company focused on the development of its leading product AIMSPRO® as a novel treatment for serious unmet medical needs through a combination of innovation, dedication, skilled science, entrepreneurship and partnership. From its inception in 2000, the management team of Daval have had a vision of making available effective treatments that noticeably improve the quality of life of patients suffering from the most serious debilitating neuro-degenerative, inflammatory and autoimmune diseases and to offer a choice over and above some of the disease modifying treatments available currently.

Victoria Foster Mitchell

Senior Consultant

Strategic Communications

F T I Consulting

+44 (0)20 3077 0486 direct

+44 (0)7816 944 230 mobile

Victoria.FosterMitchell@fticonsulting.com

Holborn Gate, 26 Southampton Buildings

London, WC2A 1PB

www.fticonsulting.com



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