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Aimspro About Aimspro Secondary Progressive MS Phase 2 Study Scleroderma Phase 2 Study Orphan Status Reference About Aimspro A pharmaceutically derived biological product that is manufactured and processed using a unique specification that is patent protected. Aimspro has passed all of the relevant regulatory authorities and industry standards and is derived from a “Caprine Hyperimmune” source. Aimspro is composed of a set of peptides that act to stimulate the release and regulation of a molecular cascade that modulates the Hypothalamo-Pituitary-Adrenal (HPA) axis. The medication demonstrates powerful antiinflammatory properties. It contains cytokines that induce a predominantly TH-2 anti-inflammatory profile in the patient. Some of the peptides in Aimspro are regulated and bound by specific carrier molecules that may regulate the action and release of their ligand (a signal triggering molecule, binding to a site on a target protein). They are probably necessary for the appropriate regulation and pharmacokinetics of the molecular machinery. The carrier molecules also function as a slow release mechanism, releasing bioactive components over several days. Side effects may occur such as. Irritation at injection site. Contra-indication. People who had initially reported a clinically satisfactory response to aimspro go on to describe periods of marked diminution of effect. How should this be dealt with? It is important, first of all, to check whether any new medication has been commenced in recent days. Highly important physiologically acting drugs will almost certainly antagonise the actions of aimspro, so if these medications have been indicated for medical reasons, then the administration of aimspro should be suspended, rather than the other way around. If the deterioration cannot be accounted for by the recent introduction of an antagonistic medication, then a careful search must be undertaken for a hidden focus of infection. This might come in the form of a urinary tract or pulmonary infection and this may happen with both bacterial and viral causative agents. Even dental abscesses and minor wound infections can have the same effect. It is very likely that the anti-inflammatory activity of aimspro is diverted to these sites of active pathology. First, the infection must be treated effectively and your health professional will be the guide to what is required to achieve this. Next, the question will arise as to whether aimspro should be discontinued for a time while the infection is dealt with. There is a logic to that approach which your health professional should have made you aware of prior to prescribing. Secondary Progressive MS Phase 2 Study Daval International announced the completion of the treatment period of its randomised, placebocontrolled, double blind Phase II Study, Treating Patients with Bladder Dysfunction with Aimspro in Secondary Progressive Multiple Sclerosis (SPMS). Standard clinical measures and assessment scores recorded on patients who have MS, as well as novel biomarkers will be used to investigate safety, efficacy and response to treatment. Daval International expects to have the initial results from this trial by the end of the summer of 2011, with secondary and tertiary outcomes (biomarker data) being made available shortly thereafter. The study completion marks more than 10 years of research and development undertaken by Daval with Aimspro. Daval International is extremely delighted to have completed this very complicated study, which is breaking new boundaries in the quest to find a cure for Secondary Progressive Multiple Sclerosis. This study was an important step towards further understanding how much Aimspro could really help people with this disease, for which there is currently no cure or therapy and the results are eagerly awaited" said Professor Syed Haq, MBBS, BSc, PhD, DIC, MCRP(UK) - Chief Scientific Officer at Daval International The Study. 20 patients participated in this randomised, placebo-controlled, double blind, crossover Phase II trial comparing Aimspro with a placebo. Subjects in both the placebo and treatment groups of the trial were given the treatment by subcutaneous injection twice weekly for 4 weeks. After a 6 week wash-out period they crossed over to receive 4 weeks of Aimspro or placebo. The primary endpoint of the study is the change in average voided volume at weeks 0 to 4 and weeks 10 to 14 respectively. The secondary endpoints of the study are to assess the efficacy of Aimspro as a therapeutic agent for SPMS noting the change in average 24hour frequency; change in visual acuity and colour vision; change in I-QOL score; change in Kurtzke EDZ assessment; change in MS Impact Scale; change in MS Functional Composite and the change in the MS Walking Scale. Source - Medical News Today © MediLexicon International Ltd 2004-2011(21/07/11) Back to Top Scleroderma Phase 2 Study October 10th 2011: Daval International announces positive Phase II results for AIMSPRO® as a monotherapy in Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma) Eastbourne, UK – Daval International announced positive results from its Double-Blind PlaceboControlled Phase II Clinical Study evaluating the safety and tolerability of AIMSPRO given as a monotherapy to patients with Late Stage Established Diffuse Cutaneous Systemic Sclerosis (diffuse scleroderma). The study evaluated the effects of 4.5mg/ml doses of AIMSPRO, administered subcutaneously, twice weekly for 26 weeks compared with placebo. The primary endpoint of the study was to evaluate the safety and tolerability of AIMSPRO in the treatment of twenty patients with Systemic Sclerosis (diffuse scleroderma) through a period of 26 weeks of study participation. The secondary outcome measures of the study were to assess the efficacy of AIMSPRO as a therapeutic agent for scleroderma using inter alia the Scleroderma Health Assessment Questionnaire, the Modified Rodnan Skin Score, the Scleroderma UK Functional Score, the Patient and Physician Global Assessment (VAS), the SF36 (Short form 36) and the MRC Sum Score. Significantly, at the end of the 26 week period AIMSPRO proved it was a safe and well-tolerated medication when administered to these especially sick patients at such a late-stage of the disease. There was no deterioration in haematological, biochemical, immunologic, cardiologic or in pulmonary parameters that were measured. In addition to the positive safety result, there were encouraging signals of clinical benefit in the secondary outcome measures. The results for the Modified Rodnan Skin Score, a validated measure of disease severity, recorded a worsening in the patients receiving placebo (changes: -27.07%, p=0.29) whereas stability was noted on the patients on AIMSPRO treatment. Furthermore, there was a distinct improvement in the overall SF-36 scores (changes: +41.6%, p=0.184) for the patients receiving AIMSPRO. There were also trends towards benefit for lung function measures. The Forced Expiratory Volume in one second (FEV1) decreased in the placebo group as compared to baseline at 26 weeks (change: -5.6%; p=0.0582) with no such deterioration being observed in the AIMSPRO treated group. Similarly, the Forced Vital Capacity (FVC) was observed to decrease in the placebo group as compared to baseline at 26 weeks (change: -5.6%, p=0.1038), but not in the AIMSPRO treated group, where the FVC showed an increase (change:+1.8%, p=0.3225). “Although requiring further confirmatory studies, these results are quite exciting, especially when compared to what has been seen in other pilot trials in scleroderma as there is a clear unmet medical need for patients suffering with this lifethreatening disease” said Professor Christopher Denton, Professor of Experimental Rheumatology at the Royal Free Hospital in London, United Kingdom, the principal investigator for the trial. “The important value of the safety data from such a well-conducted trial in such a serious disease is clear, apart from the signals of therapeutic benefit.” Daval’s Clinical and Scientific Director, Professor Syed Haq commented, “This study, conducted at one of the world’s leading scleroderma centres, was an important first step towards understanding whether AIMSPRO could significantly help patients with diffuse scleroderma and potential overlapping connective tissue disorders, for which there is no cure, by arresting the disease even in its latter stages. AIMSPRO has been shown to be well-tolerated and safe and with the several positive therapeutic signals demonstrated, some of which were significant, it certainly warrants further investigation on a larger scale to determine the full efficacy of AIMSPRO in Late Stage Established Diffuse Cutaneous Systemic Sclerosis.” Back to Top At the completion of the 26 week period of the study, AIMSPRO was offered to the patients on a compassionate use basis and the results from the 52 week visit will be presented as an addendum to the initial study report. Daval International is now assessing the biomarker data collected in this clinical trial and correlating this with the changes observed, so as to shed more light into the mechanism of action of AIMSPRO in the context of Late Stage Established Diffuse Cutaneous Systemic Sclerosis . About the Study This double-blind, randomised, placebo-controlled Phase 2a study of AIMSPRO enrolled twenty patients who received either AIMSPRO or placebo, 4.5mg/ml subcutaneously, twice weekly for 26 weeks. Standard outcome measures and novel biomarkers were used to investigate safety, efficacy and response to treatment. About Professor C. P. Denton - Professor of Experimental Rheumatology. Professor, Royal Free Hospital and University College London, UK Christopher Denton, PhD, FRCP, is Professor of Experimental Rheumatology at University College London and Consultant Rheumatologist at the Centre for Rheumatology, Royal Free Hospital, London. He graduated in medicine from Guy's Hospital, and later obtained a PhD from University College London. Following a posthealth professionalal research fellowship in molecular genetics at the University of Texas M.D. Anderson Cancer Center in Houston, USA, he was appointed as a consultant in rheumatology at the Royal Free Hospital in 2000. Professor Denton's laboratory research has focused on mediators of vasculopathy and fibrosis in connective tissue disease, and he leads a large clinical programme in scleroderma and co-ordinates multidisciplinary care for more than 1200 patients, including management of organ-based complications such as pulmonary fibrosis, pulmonary arterial hypertension and scleroderma renal crisis. He is currently President of the Scleroderma Clinical Trials Consortium (SCTC) was a founding counsellor of EUSTAR and has published extensively on laboratory and clinical aspects of connective tissue disease. Orphan Status Orphan Status for the Treatment of Amyotrophic Lateral Sclerosis has been designated to Aimspro® by the FDA. Orphan Status for the Treatment of Amyotrophic Lateral Sclerosis has been designated to Aimspro® by the TGA (Australia). Orphan Status for the treatment of ‘Krabbes Disease’ has been designated to Aimspro® by the TGA (Australia) The drug has category B status designated by the TGA (Australia) A patent for 'The Treatment of HIV' has been added to the AIMSPRO IP portfolio, having an effective date of 31st March 2009. Ref B.D. Youl, S.D.T. White, M. Cadogan, D.W. Maizels, I.C. Brooman and A.G. Dalgleish. Goat serum product 'Aimspro' restores conduction in demyelinated human optic nerve fibres. Journal of Clinical Neuroscience. 15th March 2006. (Internet publication only) R.Mackenzie, M.Kiernan, D.Mackenzie, B.D.Youl. Hyperimmune goat serum for amyotrophic lateral sclerosis. Journal of Clinical Neuroscience 2006;13:1037 Mackenzie R. Follow-up study of hyper-immune goat serum (AIMSPRO®) for amyotrophic lateral sclerosis (letter). Journal of Clinical Neuroscience (accepted for publication) Published Abstracts. Burke G, Cavey A, Matthews P, Palace J. The evaluation of a novel 'goat serum' (Aimspro) in Multiple Sclerosis. J Neurology Neurosurgery and Psychiatry 2005;76:1326 Youl BD, White SDT, McIntosh D, Cadogan M, Dalgleish AG, Ginsberg L. Hyperimmune serum reverses conduction block in demyelinated human optic nerve and peripheral nerve fibres (abstract). Joint Sino-British Neurology meeting, Beijing. J Neurology Neurosurgery and Psychiatry 2004;76:615 Back to Top Moore CEG, Hannan R, McIntosh D. In vivo, human peripheral nerve strength duration time constant changes with Aimspro implicate altered sodium channel function as a putative mechanism of action. Journal of the Neurological Sciences. 2005; Vol 238: Suppl. 1. pS238. (World Congress of Neurology, 2005) Youl BD, Crum J. Clinical Improvement in Krabbe's Disease case treated with hyperimmune goat serum product Aimspro. Journal of the Neurological Sciences. 2005; Vol 238: Suppl. 1. pS110. (World Congress of Neurology, 2005) Youl BD, Angus-Leppan H, Hussein N, Brooman I, Fitzsimons RB. Rapid and sustained response to hyperimmune goat serum product in a patient with Myaesthenia Gravis. Journal of the Neurological Sciences. 2005; Vol 238: Suppl. 1. pS177. (World Congress of Neurology, 2005) Youl BD, Orrell R. Goat serum product Aimspro produces sustained improvement in muscle power in a patient with Fascioscapulohumeral Dystrophy. Journal of the Neurological Sciences. 2005; Vol 238: Suppl. 1. pS169. (World Congress of Neurology, 2005) Youl BD, White SDT, Cadogan MA, Dalgleish AG (2004). Goat Serum product restores conduction in demyelinated human optic nerve fibres (abstract). J Neurology Neurosurgery and Psychiatry 2005;76:615 (doi: 10.1016/j.clinph.2006.07.239) Youl BD, Ginsberg L (2004). Goat serum product AIMSPRO shows promise as an effective treatment in CIDP (abstract). BSCN meeting, National Hospital, London, 21st October 2004 doi: 10.1016/j.clinph.2006.07.249 Moore CEG, Youl BD, Moore WMH, Orrel R (2005). Multimodality neurophysiological testing in the assessment of a novel therapeutic approach to Leukodystrophy and Charcot-Marie-Tooth disease (abstract). BSCN meeting, Sheffield, 18th March 2005 – doi: 10.1016/j.clinph.2006.07.264 Mackenzie R, Kiernan M, McKenzie D, Youl BD (2005). Follow-up study of hyperimmune goat serum in a patient with Amyotrophic Lateral Sclerosis (abstract). 16th International Symposium on ALS/MND, Dublin