TOORAK, Australia, July 29, 2014 /PRNewswire/ -- Antisense
Therapeutics Limited ("ANP") is pleased to report that dosing of
all 26 patients in the Phase II trial of ATL1103 for the
potentially life-threatening growth disorder, acromegaly has now
been completed. There were no patient withdrawals or reports of any
serious adverse events related to dosing with ATL1103. Patients
will continue to be monitored for a period of two months after
their last dose of ATL1103.
Primary efficacy results are expected by the end of August 2014. The primary efficacy endpoint of the
trial is the percentage reduction from each patient's baseline
serum IGF-I levels to their levels one week after the completion of
dosing with ATL1103. Acromegaly patients have elevated serum IGF-I
levels compared to the normal population and reducing their serum
IGF-I to within a normal range is accepted by clinical authorities
as the therapeutic goal for treatment of the disease. Positive
results from an Interim Analysis (as announced on 23 December 2013) of the data from the first 8
patients who had completed their dosing in this Phase II trial
provided important indicative data on the efficacy of ATL1103 with
the serum IGF-I reductions achieved with ATL1103 in line with
reductions that could be therapeutically effective.
To assess the primary efficacy endpoint based on all 26 patients
who have now completed dosing with ATL1103, the blood samples
collected from all patients will be shipped from the trial sites in
the UK, Central Europe and
Australia to a laboratory in
Germany for measurement of serum
IGF-I. When the laboratory has completed the assays, the IGF-I
values will be transferred to the contract research organisation
(CRO) in the UK for entry into the trial database. After all
checks are complete the IGF-I data will be statistically analysed
and reported. ANP expects to receive the results of the primary
efficacy endpoint by the end of August
2014.
Antisense Therapeutics Limited CEO and Managing Director
Mark Diamond said "The reporting of
the Phase II trial results will not only be a significant milestone
for the Company, but potentially also for patients with this life
threatening condition where there is a need for more effective
treatment options. Notably for shareholders, achievement of a
successful Phase II trial result would be a transforming event for
ANP, putting us amongst a select and higher valued group of
companies in the Australian biotech sector with successful late
stage project assets. We look forward to reporting to shareholders
on this important development project and the opportunities that it
may open up for the Company."
Background Information
ATL1103 Phase II trial is a randomised, open-label,
parallel group study of the safety, tolerability, pharmacokinetics
and efficacy of two subcutaneous dosing regimens of ATL1103 in 26
adult patients with acromegaly dosed with ATL1103 for 13 weeks (3
months) with two months of follow up. Two ATL1103 dosing regimens
are being tested (a)
200 mg 3 times in the first week then once weekly thereafter
(200 mg/week) or (b) 200 mg 3 times in the first week then twice
weekly thereafter (400 mg/week). The primary endpoints or main
purposes of the trial as listed on the trial protocol are (i) to
evaluate the safety and tolerability of ATL1103 in patients with
acromegaly, and (ii) to evaluate the
single dose and multiple dose pharmacokinetic profiles of
ATL1103 via the subcutaneous route in patients with acromegaly.
Another important endpoint that is also on the trial protocol is
the evaluation of ATL1103's effect on serum insulin like growth
factor I (IGF-I) levels in patients. This efficacy endpoint is the
average percentage reduction in serum IGF-I levels at the end of
treatment compared to baseline levels for each of the two dosing
regimens used in the Phase II study.
ATL1103 is a second generation antisense drug designed to
block growth hormone receptor (GHr) expression thereby reducing
levels of the hormone insulin-like growth factor-I (IGF-I) in the
blood and is a potential treatment for diseases associated with
excessive growth hormone and IGF-I action. These diseases include
acromegaly, an abnormal growth disorder of organs, face, hands and
feet, diabetic retinopathy, a common disease of the eye and a major
cause of blindness, diabetic nephropathy, a common disease of the
kidney and major cause of kidney failure, and some forms of cancer.
Acromegalic patients are known to have significantly higher blood
IGF-I levels than healthy individuals. Reduction of these levels to
normal is accepted by clinical authorities as the primary marker of
an effective drug treatment for the disease. GHr is a clinically
validated target in the treatment of acromegaly. In the case of
diabetic retinopathy, published clinical studies have shown that
treatments producing a reduction in IGF-I levels retarded the
progression of the disease and improve vision in patients.
Scientific papers have been published on the suppression of blood
IGF-I levels in mice (Tachas et al., 2006, J Endocrinol 189,
147-54) and inhibition of retinopathy in a mouse retinopathy model
(Wilkinson-Berka et al., 2007, Molecular Vision 13, 1529- 38;)
using an antisense drug to the GHr. ANP have also reported that
ATL1103 suppressed circulating levels of IGF-I in primates. In a
Phase I study in normal volunteers, ATL1103 was assessed as being
safe and well tolerated, while also demonstrating a preliminary
indication of drug activity including suppression of IGF-I and the
target GHR (growth hormone binding protein) levels. ATL1103
commercialisation is covered by patents to at least 2024, with the
potential for extensions up to 2029 in some countries and 2030 in
the US.
Acromegaly is a serious chronic life threatening disease
triggered by excess secretion of growth hormone (GH) by benign
pituitary tumours. Oversupply of GH over stimulates liver, fat and
kidney cells, through their GH receptors, to produce excess levels
of (IGF-I) in the blood manifesting in abnormal growth of the face,
hands and feet, and enlargement of body organs including liver,
kidney and heart. The primary treatments for acromegaly are to
surgically remove the pituitary gland and/or drug therapy to
normalize GH and serum IGF-I levels. In North America and Europe there are approximately 85,000
acromegaly patients with about half requiring drug therapy. Cost of
drug therapy ranges from approximately A$30,000/annum to over A$60,000/annum depending on the treatment.
Contact Information:
Website: www.antisense.com.au
Managing Director: Mark Diamond +61
(3) 9827 8999
Investor Relations: Annabel
Murphy, Buchan Consulting +61 (2) 9237 2800
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.
SOURCE Antisense Therapeutics Limited