News Alert for: ATL1102 - smh.com.au - The Sydney Morning Herald
Name of Entity:
Antisense Therapeutics Limited
ATL1102 (TV1102) for Multiple Sclerosis
Projects Update
The Company's business model of outsourcing pre-clinical and clinical testing minimises infrastructure
and overhead costs. The Company works with contractors and consultants on a worldwide basis in
order to gain access to the best possible expertise in each area of the Company's research and
development operations. These outsourcing activities are closely controlled by the Company's
management, which has extensive experience in the research and clinical development of
pharmaceutical products.
Isis Strategic Partnership
An important element of the Antisense Therapeutics strategy is its access to leading antisense
technology derived from its strategic partnership with Isis. Isis currently has one antisense drug on the
market and 18 antisense products in development (either alone or in partnership with other
pharmaceutical companies). Isis has several partnerships with major pharmaceutical companies,
including drug development collaborations with Ely Lilly & Co, Bristol-Myers Squibb, and Ortho-McNeil,
Inc., a Johnson & Johnson company. Isis also recently reported a very significant licensing transaction
with Genzyme Inc on Isis' second-generation antisense drug Mipomersen.
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 halting
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, the MS animal data having been published in a peer reviewed scientific journal.
What is Multiple Sclerosis?
Multiple Sclerosis (MS) is a life-long, chronic disease that progressively destroys the central nervous
system (CNS). It affects approximately 400,000 people in North America and the current market for
MS drugs is estimated at more than USD$6 billion. It is a disease that affects more women than men,
with onset typically occurring between 20 and 40 years of age. Symptoms of MS may include vision
problems, loss of balance, numbness, difficulty walking and paralysis. In Australia MS affects over
15,000 people and worldwide MS may affect more than one million people.
Progress
As previously reported, the Company conducted an international, multi-centre, randomised, double-
blinded, placebo-controlled Phase IIa clinical trial of ATL1102 in 77 patients with relapsing-remitting
MS (RRMS) with the objective to assess the activity and safety of the drug in MS patients.
3
Teva are to fund and perform all future development of ATL1102 beyond the Phase IIa trial. Royalties,
payable on net sales of ATL1102, are in the low double digit range and are tiered according to annual
net sales achieved. The agreement also provides an option for Teva to in-license ATL1102 as an
aerosol drug for asthma.
Under a separate Collaboration and License Agreement between Antisense Therapeutics and Isis,
Antisense Therapeutics is required to pay Isis one third of sublicense fees and milestone payments
received from Teva as well as a percentage of any royalties Antisense Therapeutics receives.
On 17 April 2008 Antisense Therapeutics Ltd reported that it had completed its Phase IIa clinical trial of
ATL1102 in patients with RRMS and that all patients had completed their final clinical assessment
following dosing with either ATL1102 or placebo injections. The Company reported that the next step
was to finalise entry of the clinical trial data into the trial database after which the database was to be
closed or "locked" to any further data input. The study data was then to be unblinded for statistical
analysis after which the trial results would be reported to the market; at that time anticipated for mid
2008.
The International application entitled "Antisense modulation of integrin alpha 4 expression" filed on 19
August 1999 claims priority from US application 09/166 203 filed 5 October 1998.
Patents have been granted in the US, Japan, Australia, United Kingdom, Germany, France, Italy,
Spain, Denmark, Finland, and Sweden. Patent applications are under examination in Canada and
Japan. These granted patents form part of the extensive portfolio of intellectual property protecting
ATL1102 and its applications in the treatment of MS, asthma and other diseases.
On 30 June 2008 Teva and Antisense Therapeutics announced the results of the Phase IIa MS trial
and reported that ATL/TV1102 (ne ATL1102) significantly reduced disease activity in patients with
RRMS and that the Phase IIa study met its primary endpoint showing a significant reduction by 54.4%
(p=0.01) in cumulative number of new active lesions in patients taking ATL/TV1102 for 8 weeks,
compared to placebo, as measured by magnetic resonance images (MRI). ATL/TV1102 demonstrated
an increasing effect with time on the reduction of new active lesions over 12 weeks - one month after
the completion of dosing. This extended duration of activity post dosing was anticipated based on the
drug's long (>3 week) half-life, and would support the proposition of less frequent dosing than the twice
weekly dosing employed in the current trial though this would need to be confirmed in future clinical
In the period the Isis Patent Family, International application PCT/US99/18796, and related patents
and applications below, covering ATL1102, methods of reducing integrin alpha 4 expression and
methods of treatment of disease including MS and asthma using ATL1102 were assigned to the
Company.
In February 2008 Antisense Therapeutics exclusively out-licensed these patents and patent
applications to Teva.
Patent Status
ATL1102 patents and patent applications
Based on these encouraging results, Teva advised that it intended to continue with the development of
the drug with the conduct of additional pre-clinical and clinical research before continuing to a Phase III
study with ATL/TV1102. This decision by Teva to move forward with the development of ATL/TV1102
triggered a US$4 million milestone payment in accordance with the license agreement between Teva
and Antisense Therapeutics.
studies. Data from this study demonstrated that in general, ATL/TV1102 was well-tolerated. Potentially
attributable adverse events included injection site reactions which were mild to moderate and
thrombocytopenia. Thrombocytopenia was reversible after treatment interruption returning to within
normal ranges and was not accompanied with any clinical consequences.
ATL1102 for Asthma
Patent Status
** Designates all member states of European patent countries including all extension states.
As referred to in the ATL1102 for MS section of this report, the Company has licensed ATL1102 to
Teva. The Licensing Agreement provides an option for Teva to in-license the ATL1102 aerosol drug for
asthma.
New Zealand
541637
Under Examination
2024
Japan
2006-501357
Under Examination
2024
Europe**
04709958.5
Under Examination
2024*
Canada
2515484
Awaiting Examination
2024
2024*
The International application entitled, "Modulation of Insulin Like Growth Factor I Receptor Expression"
filed 11 February 2004 claims priority from Au 2003900609 and Au 2003902610 filed 11 February 2003
and 27 May 2003 respectively.
We have entered this application into the National Phase in Australian, Canada, Europe, Japan, New
Zealand and the United States. A further US patent application US20040171149 has also been
lodged.
Patent Status
Antisense Therapeutics have lodged an International patent application PCT/AU2004/000160 covering
ATL1101 and methods of treatment of diseases including prostate cancer.
International
PCT/AU2004/00160
Australia
2004210882
Under Examination
National Phase applications
US
US10/365352
2004/0171149
Under Examination
2023
ATL1101 patent applications
We have entered this application into the National Phase in the United States, Japan, Europe,
Canada, New Zealand and Australia. The Patent application is under examination in Europe.
Country
Patent application or
Patent No.
Current Status
Expiry
The Company has previously reported encouraging results achieved in an animal model of asthma
with the inhaled form of an antisense compound targeting the VLA-4 molecule. Experimental studies
showed that the delivery of an antisense drug against VLA-4 via inhalation to the lung significantly
suppressed the key asthma indicators in allergen sensitised mice at very low inhaled doses, pointing to
the potential new indication for ATL1102 as an inhaled treatment for asthma.
USA
US10/545354
2006/0234239
Under Examination
2024
ATL1102 inhaled patent applications
The international application entitled "Topical administrations of antisense compounds to VLA-4 for the
treatment of respiratory conditions" filed on 20 October 2005 claims priority from US applications US
60/620,792 and US 60/648,820 filed 20 October 2004 and 31 January 2005 respectively.
Antisense Therapeutics have lodged International patent application PCT AU 2005/001634 for low
dose inhaled ATL1102 for use in asthma and other respiratory conditions.
ATL1102 licensed to global pharmaceutical company Teva Pharmaceuticals Industries Ltd (Teva);
Successful ATL1102 Phase IIa MS trial;
Teva confirmed their intention to continue the development of ATL1102 for MS with Teva to fund all development of
ATL1102 going forward;
http://newsstore.smh.com.au/apps/previewDocument.ac?docID=GCA00869021ANP
http://newsstore.smh.com.au/apps/previewDocument.ac?docID=GCA00869021ANP
Name of Entity:
Antisense Therapeutics Limited
ATL1102 (TV1102) for Multiple Sclerosis
Projects Update
The Company's business model of outsourcing pre-clinical and clinical testing minimises infrastructure
and overhead costs. The Company works with contractors and consultants on a worldwide basis in
order to gain access to the best possible expertise in each area of the Company's research and
development operations. These outsourcing activities are closely controlled by the Company's
management, which has extensive experience in the research and clinical development of
pharmaceutical products.
Isis Strategic Partnership
An important element of the Antisense Therapeutics strategy is its access to leading antisense
technology derived from its strategic partnership with Isis. Isis currently has one antisense drug on the
market and 18 antisense products in development (either alone or in partnership with other
pharmaceutical companies). Isis has several partnerships with major pharmaceutical companies,
including drug development collaborations with Ely Lilly & Co, Bristol-Myers Squibb, and Ortho-McNeil,
Inc., a Johnson & Johnson company. Isis also recently reported a very significant licensing transaction
with Genzyme Inc on Isis' second-generation antisense drug Mipomersen.
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 halting
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, the MS animal data having been published in a peer reviewed scientific journal.
What is Multiple Sclerosis?
Multiple Sclerosis (MS) is a life-long, chronic disease that progressively destroys the central nervous
system (CNS). It affects approximately 400,000 people in North America and the current market for
MS drugs is estimated at more than USD$6 billion. It is a disease that affects more women than men,
with onset typically occurring between 20 and 40 years of age. Symptoms of MS may include vision
problems, loss of balance, numbness, difficulty walking and paralysis. In Australia MS affects over
15,000 people and worldwide MS may affect more than one million people.
Progress
As previously reported, the Company conducted an international, multi-centre, randomised, double-
blinded, placebo-controlled Phase IIa clinical trial of ATL1102 in 77 patients with relapsing-remitting
MS (RRMS) with the objective to assess the activity and safety of the drug in MS patients.
3
Teva are to fund and perform all future development of ATL1102 beyond the Phase IIa trial. Royalties,
payable on net sales of ATL1102, are in the low double digit range and are tiered according to annual
net sales achieved. The agreement also provides an option for Teva to in-license ATL1102 as an
aerosol drug for asthma.
Under a separate Collaboration and License Agreement between Antisense Therapeutics and Isis,
Antisense Therapeutics is required to pay Isis one third of sublicense fees and milestone payments
received from Teva as well as a percentage of any royalties Antisense Therapeutics receives.
On 17 April 2008 Antisense Therapeutics Ltd reported that it had completed its Phase IIa clinical trial of
ATL1102 in patients with RRMS and that all patients had completed their final clinical assessment
following dosing with either ATL1102 or placebo injections. The Company reported that the next step
was to finalise entry of the clinical trial data into the trial database after which the database was to be
closed or "locked" to any further data input. The study data was then to be unblinded for statistical
analysis after which the trial results would be reported to the market; at that time anticipated for mid
2008.
The International application entitled "Antisense modulation of integrin alpha 4 expression" filed on 19
August 1999 claims priority from US application 09/166 203 filed 5 October 1998.
Patents have been granted in the US, Japan, Australia, United Kingdom, Germany, France, Italy,
Spain, Denmark, Finland, and Sweden. Patent applications are under examination in Canada and
Japan. These granted patents form part of the extensive portfolio of intellectual property protecting
ATL1102 and its applications in the treatment of MS, asthma and other diseases.
On 30 June 2008 Teva and Antisense Therapeutics announced the results of the Phase IIa MS trial
and reported that ATL/TV1102 (ne ATL1102) significantly reduced disease activity in patients with
RRMS and that the Phase IIa study met its primary endpoint showing a significant reduction by 54.4%
(p=0.01) in cumulative number of new active lesions in patients taking ATL/TV1102 for 8 weeks,
compared to placebo, as measured by magnetic resonance images (MRI). ATL/TV1102 demonstrated
an increasing effect with time on the reduction of new active lesions over 12 weeks - one month after
the completion of dosing. This extended duration of activity post dosing was anticipated based on the
drug's long (>3 week) half-life, and would support the proposition of less frequent dosing than the twice
weekly dosing employed in the current trial though this would need to be confirmed in future clinical
In the period the Isis Patent Family, International application PCT/US99/18796, and related patents
and applications below, covering ATL1102, methods of reducing integrin alpha 4 expression and
methods of treatment of disease including MS and asthma using ATL1102 were assigned to the
Company.
In February 2008 Antisense Therapeutics exclusively out-licensed these patents and patent
applications to Teva.
Patent Status
ATL1102 patents and patent applications
Based on these encouraging results, Teva advised that it intended to continue with the development of
the drug with the conduct of additional pre-clinical and clinical research before continuing to a Phase III
study with ATL/TV1102. This decision by Teva to move forward with the development of ATL/TV1102
triggered a US$4 million milestone payment in accordance with the license agreement between Teva
and Antisense Therapeutics.
studies. Data from this study demonstrated that in general, ATL/TV1102 was well-tolerated. Potentially
attributable adverse events included injection site reactions which were mild to moderate and
thrombocytopenia. Thrombocytopenia was reversible after treatment interruption returning to within
normal ranges and was not accompanied with any clinical consequences.
ATL1102 for Asthma
Patent Status
** Designates all member states of European patent countries including all extension states.
As referred to in the ATL1102 for MS section of this report, the Company has licensed ATL1102 to
Teva. The Licensing Agreement provides an option for Teva to in-license the ATL1102 aerosol drug for
asthma.
New Zealand
541637
Under Examination
2024
Japan
2006-501357
Under Examination
2024
Europe**
04709958.5
Under Examination
2024*
Canada
2515484
Awaiting Examination
2024
2024*
The International application entitled, "Modulation of Insulin Like Growth Factor I Receptor Expression"
filed 11 February 2004 claims priority from Au 2003900609 and Au 2003902610 filed 11 February 2003
and 27 May 2003 respectively.
We have entered this application into the National Phase in Australian, Canada, Europe, Japan, New
Zealand and the United States. A further US patent application US20040171149 has also been
lodged.
Patent Status
Antisense Therapeutics have lodged an International patent application PCT/AU2004/000160 covering
ATL1101 and methods of treatment of diseases including prostate cancer.
International
PCT/AU2004/00160
Australia
2004210882
Under Examination
National Phase applications
US
US10/365352
2004/0171149
Under Examination
2023
ATL1101 patent applications
We have entered this application into the National Phase in the United States, Japan, Europe,
Canada, New Zealand and Australia. The Patent application is under examination in Europe.
Country
Patent application or
Patent No.
Current Status
Expiry
The Company has previously reported encouraging results achieved in an animal model of asthma
with the inhaled form of an antisense compound targeting the VLA-4 molecule. Experimental studies
showed that the delivery of an antisense drug against VLA-4 via inhalation to the lung significantly
suppressed the key asthma indicators in allergen sensitised mice at very low inhaled doses, pointing to
the potential new indication for ATL1102 as an inhaled treatment for asthma.
USA
US10/545354
2006/0234239
Under Examination
2024
ATL1102 inhaled patent applications
The international application entitled "Topical administrations of antisense compounds to VLA-4 for the
treatment of respiratory conditions" filed on 20 October 2005 claims priority from US applications US
60/620,792 and US 60/648,820 filed 20 October 2004 and 31 January 2005 respectively.
Antisense Therapeutics have lodged International patent application PCT AU 2005/001634 for low
dose inhaled ATL1102 for use in asthma and other respiratory conditions.
ATL1102 licensed to global pharmaceutical company Teva Pharmaceuticals Industries Ltd (Teva);
Successful ATL1102 Phase IIa MS trial;
Teva confirmed their intention to continue the development of ATL1102 for MS with Teva to fund all development of
ATL1102 going forward;
http://newsstore.smh.com.au/apps/previewDocument.ac?docID=GCA00869021ANP
http://newsstore.smh.com.au/apps/previewDocument.ac?docID=GCA00869021ANP
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