TOORAK, Australia, April
1, 2014 /PRNewswire/ -- 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 months."
Background Information
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 pre-clinical 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.
Contact Information:
Website: www.antisense.com.au
Managing Director: Mark Diamond +61
(3) 9827 8999
USA Investor/Media: Joshua Drumm +(1) 212 375 2664;
jdrumm@tiberend.com
Australia Investor/Media: Simon
Watkin +61 (0)413 153 272; simon@marketconnect.com.au
SOURCE Antisense Therapeutics Limited