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Aimspro
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About Aimspro
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Secondary Progressive MS Phase 2 Study
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Scleroderma Phase 2 Study
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Orphan Status
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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)
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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.”
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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
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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