4/1/2014 9:00:25 AM
1 April 2014 -- Antisense Therapeutics Limited (“ANP” or the “Company”) is pleased to advise that results from a
chronic toxicity study in monkeys indicate that ATL1102, an antisense oligonucleotide currently under
development for the treatment of multiple sclerosis (MS), was well-tolerated when given
subcutaneously for a 6-month dosing period at the 2 dose levels tested (1.5 and 3mg/kg/dose). The
Company believes that the preclinical and clinical experience to date with ATL1102 should allow dosing
in future trials at or above the 1.5 mg/kg/dose level.
Based on histologic findings in common with a previous monkey study at doses exceeding
1.5mg/kg/dose, the Company continues to evaluate the chronic monkey data with regard to potential
human relevance, and safety biomarkers that may be useful in future clinical studies. Exposures
achieved in this study are regarded as potentially clinically relevant based on the efficacy outcomes
from the previously conducted Phase IIa trial of ATL1102 in MS patients.
Pending receipt and final data evaluation from the current study, as well as review of all the preclinical
and clinical data obtained, ANP is planning future regulatory agency discussions regarding further
development of ATL1102 and the dosing regimen for a future Phase IIb trial in MS patients. The
Company anticipates final review of the data by June this-year and follow-up discussions with the US
Food and Drug Administration (FDA) at a pre-IND meeting during the 3rd quarter 2014.
Antisense Therapeutics CEO and Managing Director Mark Diamond said “The results of this most recent
toxicology study and the human data to date are encouraging and re-ignite our hopes for this project.
We are continuing to generate new data on ATL1102 which we believe will support positive interactions
with the FDA in relation to our plans for a future Phase IIb trial in MS patients. We look forward to
confirming our plans for the further clinical development of ATL1102 with the FDA in the coming
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 multiple sclerosis,
ATL1103 a second-generation antisense drug designed to block GHr production and thereby lower blood IGF-I levels and is
in clinical development as a potential treatment for growth and other GH-IGF-I disorders, 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 preclinical
stage being investigated as a potential treatment for cancer.
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 Antisense Therapeutics to be highly effective in reducing MS lesions in a Phase IIa clinical trial in MS patients.
Managing Director: Mark Diamond +61 (3) 9827 8999
USA Investor/Media: Joshua Drumm +(1) 212 375 2664; firstname.lastname@example.org
Australia Investor/Media: Simon Watkin +61 (0)413 153 272; email@example.com
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