TOORAK, Australia, Sept. 22, 2014 /PRNewswire/ -- Antisense
Therapeutics (the "Company" or "ANP") is pleased to report the
publication of previously generated Phase IIa clinical trial data
on ATL1102 in the medical journal Neurology.
The article titled "CD49d antisense drug ATL1102 reduces disease
activity in patients with relapsing-remitting MS", is currently
available online and will be included in the print edition Volume
83, November 11, 2014.
The article highlights the successful outcomes of the Phase IIa
clinical trial of ATL1102 in Multiple Sclerosis (MS) patients where
in the randomised, double-blind, placebo-controlled study in 77
patients with relapsing-remitting multiple sclerosis (RRMS),
ATL1102 met its primary end point after only two months of dosing,
showing a significant reduction, by 54.4% (p=0.01) in the
cumulative number of new active brain lesions in patients taking
ATL1102 compared to placebo.
The efficacy outcomes from this study were viewed to be as good
as, or superior to, those achieved with MS drug Tysabri®
at a similar stage in its clinical development. Tysabri®
(natalizumab) is a monoclonal antibody drug targeting the VLA-4
receptor (same target as ATL1102). In 2013, Tysabri®
generated sales in excess of US$1.6
billion. It is regarded as the current efficacy benchmark
for the treatment of RRMS. ANP anticipates that ATL1102 could be as
potent as Tysabri® but potentially safer, cheaper to
manufacture, and more conveniently dosed.
Principal Investigator of the ATL1102 Phase IIa study and lead
author of the Neurology publication, Volker Limmroth (MD PhD Professor of Neurology,
Chairman Department of Neurology and Palliative Care Medicine
Cologne City Hospitals, University of Cologne) said:
"There are a number of unresolved issues with current MS drugs
including the occurrence of neutralising antibodies to the
antibody, protein and peptide MS drugs as well as long-term safety
concerns with the more recently approved drugs. There is a clear
need for more effective and safe drugs for the significant
population of MS patients who have relapses and non-stable
disease.
The ATL1102 Phase IIa trial provides evidence for the first time
that antisense oligonucleotides may be used as a therapeutic
approach in neuroimmunologic disorders such as MS. ATL1102 was
shown to be highly effective in reducing brain lesions in RRMS
patients with a quick onset of action and a clinical safety profile
that strongly supports its ongoing development as a treatment for
this disease."
The full article can be downloaded from
http://www.neurology.org/content/early/recent
Antisense Therapeutics CEO and Managing Director Mark Diamond said:
"The Journal of the American Academy of Neurology is the most
widely read and highly cited peer-reviewed Neurology Journal.
Having our ATL1102 Phase II data published in such a high quality
scientific journal is extremely beneficial for the future
development and partnering plans for the drug and our current FDA
interactions. It also provides further independent validation to
the quality of our data and considerable development progress made
by the Company in advancing ATL1102."
ATL1102 background Information ATL1102 is a second
generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very
Late Antigen-4). In inflammation, white blood cells (leukocytes)
move out of the bloodstream into the inflamed tissue, for example,
the Central Nervous System (CNS) in MS, and the lung airways in
asthma. The inhibition of VLA-4 may prevent white blood cells from
entering sites of inflammation, thereby slowing progression of the
disease. VLA-4 is a clinically validated target in the treatment of
MS. Antisense inhibition of VLA-4 has demonstrated positive effects
in a number of animal models of inflammatory disease including MS
with the MS animal data having been published in a peer reviewed
scientific journal. ATL1102 was previously shown by the Company to
be highly effective in reducing MS lesions in a Phase II clinical
trial in RRMS patients with the primary study results reported in
2008. The efficacy outcomes from this study were viewed to be
as good as, or superior to, those achieved with Tysabri®
(natalizumab) the monoclonal antibody drug to the VLA-4 receptor
(same target as ATL1102), at a similar stage in its clinical
development. Tysabri® can cause a potential lethal viral brain
infection known as progressive multi focal leukoencephalopathy
(PML) The company anticipates that ATL1102 could be as potent as
Tysabri® (2013 sales - US$1.67
billion) but potentially safer (possibly not causing PML),
cheaper to manufacturer, and more conveniently (self) administered.
Following the successful Phase IIa trial, ATL1102 was then tested,
amongst several other animal safety studies, in a chronic primate
toxicology study. An unexpected adverse finding was noted in that
study. ANP subsequently completed a new chronic primate toxicology
to support a potential Phase IIb clinical trial. As recently
reported, the new animal toxicology results on ATL1102 have
provided ANP with an opportunity to resume its plans for the
further clinical development of ATL1102. The Company is now seeking
US Food and Drug Administration's (FDA) guidance and agreement on
the intended content of the planned IND Submission. The FDA has
confirmed that its goal date for responding to the Company's is
October 17, 2014.
Contact Information:
Website: www.antisense.com.au
Managing Director: Mark Diamond +61
(0)3 9827 8999
Australian Investor/Media: Annabel Murphy+61 (0)2 9237 2800;
amurphy@buchanwe.com.au
USA Investor/Media: Joshua Drumm +(1) 212 375 2664;
jdrumm@tiberend.com
Antisense Therapeutics Limited (ASX: ANP) is an
Australian publicly listed biopharmaceutical drug discovery and
development company. Its mission is to create, develop and
commercialise second generation antisense pharmaceuticals for large
unmet markets. ANP has 4 products in its development pipeline that
it has in-licensed from Isis Pharmaceuticals Inc., world leaders in
antisense drug development and commercialisation - ATL1102
(injection) which has successfully completed a Phase II efficacy
and safety trial, significantly reducing the number of brain
lesions in patients with relapsing-remitting multiple sclerosis
(RRMS) , ATL1103 a second-generation antisense drug designed to
block GHr production which in a Phase II clinical trial,
successfully reduced blood IGF-I levels in patients with the
growth disorder acromegaly, ATL1102 (inhaled) which is at the
pre-clinical research stage as a potential treatment for asthma and
ATL1101 a second-generation antisense drug at the pre-clinical
stage being investigated as a potential treatment for cancer.
SOURCE Antisense Therapeutics Limited
