Daval International Limited CSO Presents Results From an Exploratory Clinical Trial of AIMSPRO in Amyotrophic Lateral Sclerosis (ALS) at American Academy of Neurology Annual Meeting
The AAN annual meeting is the world’s largest international congress of neurologists and neuroscience professionals.
Professor Haq presented data from a 21 patient, single arm, multi-centre, multi-national, open-label, exploratory clinical trial examining subcutaneous injections of hyperimmune caprine sera (HICS, AIMSPRO®) as a novel potential treatment for ALS.
Results from the study showed that there was no fall in the ALSFRS-R score[1], a validated, physician-reported endpoint used in ALS trials and one of the primary endpoints of the trial. Additionally a number of other clinical endpoints showed statistically significant signs of improvement. Importantly no adverse events related to the drug were recorded during the study, confirming the benign adverse event profile also seen in two recently completed, double-blind placebo-controlled phase II trials in secondary progressive multiple sclerosis and late stage systemic sclerosis (scleroderma).
Professor Haq also presented data from a supportive preclinical study in the standard SOD1 mouse model of motor neuron disease, comparing a cohort of mice injected subcutaneously with AIMSPRO to a control group injected with vehicle. While AIMSPRO delayed the onset of disease in this model, no increase in survival was observed in Kaplan-Meier survival plots. However a number of other endpoints were met including survival plots based on clinical score.
A putative novel mechanism of action for the protective therapeutic action observed with AIMSPRO was also presented. Data supporting this mechanism will be presented in more detail in a peer-reviewed journal in the coming months.
The poster abstract will be available for download on Daval International’s website, www.davalinternational.com, from 21 March, 2013, 07:00 am GMT.
Professor Haq commented, “We are excited by the data generated in both the exploratory clinical trial and relevant preclinical model of disease that suggest AIMSPRO may be an effective and safe treatment for patients with ALS, a significant unmet medical need. Particularly intriguing is the elucidation of a novel mechanism of action that is consistent with AIMSPRO use to treat a wide number of neurological conditions.”
For further information please contact:
Daval International Ltd
James Shotton +1 303 588 5881 or +44 (0)7739 648 401
Chief Executive
NM Rothschild
Julian Hudson +44 (0) 20 7280 5000
FTI Consulting
Julia Phillips / Simon Conway / Matthew Cole +44 (0)20 7831 3113
[1] The ALSFRS-R is a validated physician-generated estimate of the patient’s degree of functional impairment, which can be evaluated serially to objectively assess any response to treatment or progression of disease. The ALSFRS includes 12 questions that ask the physician to rate his/her impression of the patient’s level of functional impairment in performing common tasks. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 48=best.
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 is an emerging life sciences company focused on the development of novel treatments 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.
About Amyotrophic Lateral Sclerosis (ALS)
ALS, also known as Lou Gehrig's disease, is the most prevalent form of motor neuron disease, which generally strikes people between 40 and 60 years of age. It is estimated that there are over 400,000 patients living with ALS globally. It is a neurodegenerative disease with limited treatment options and poor prognosis. It is characterised by progressive loss of both lower (spinal cord and brain stem) and upper (cerebral cortex) motor neurons, which leads to severe muscle weakness and wasting, followed by paralysis and death, generally caused by respiratory failure. There is an urgent need for the development of new approaches to this devastating condition.