Teva & ANP Announce That ATL/TV1102, a Novel Drug for the Treatment of Relapsing Remitting Multiple Sclerosis (RRMS), Demonstrated Significant Reduction in Disease Activity
-- Results Demonstrate Impressive Reduction of Disease Activity as
Early as 8 Weeks -
-- Teva Intends to Conduct Additional Pre-Clinical and Clinical
Research Before Continuing to a Phase III Study with this Unique and
Promising Molecule --
JERUSALEM & MELBOURNE, Australia--(Business Wire)--
Teva Pharmaceutical Industries Ltd. (NASDAQ: Teva) and Antisense
Therapeutics Ltd. (ASX: ANP) announced today that ATL/TV1102, a novel,
anti-sense drug, significantly reduced disease activity in patients
with relapsing-remitting multiple sclerosis (RRMS). A randomized,
double-blind, placebo-controlled 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).
Based on these encouraging results, Teva intends to conduct
additional pre-clinical and clinical research before continuing to a
Phase III study with this unique and promising molecule.
The Principal Investigator for the trial, Volker Limmroth MD PhD,
Chairman of the Department of Neurology, Cologne City Hospitals,
Germany, said, "The results of this international multi-center
clinical study are very encouraging and demonstrate a highly
significant effect for ATL/TV1102 on disease activity in MS patients."
"Following these results, we are planning to continue the
development of this new and exciting molecule designed to confirm the
efficacy of ATL/TV1102," said Moshe Manor, Teva's Group Vice
President, Global Innovative Resources. "Together with COPAXONE(R), a
market-leading MS therapy and Laquinimod, an oral MS treatment
currently in Phase III studies, Teva continues with its commitment to
help MS patients and improve their quality of life."
"We are very pleased with the results of this study. Achieving the
primary endpoint to such a significant degree vindicates our efforts
in developing this unique drug, the first to use antisense technology
in the treatment of MS. We now look forward to continuing the
development of ATL/TV1102 for MS with one of the leading
pharmaceutical companies in the world", said Mark Diamond, Chief
Executive Officer of Antisense Therapeutics Ltd.
Teva is responsible for funding and performing future development
activities as outlined above for ATL/TV1102. This decision by Teva to
move forward with the development of ATL/TV1102 triggers a US$4
million milestone payment in accordance with the license agreement
between Teva and ANP.
Study Design and Results
ATL/TV1102 Phase IIa trial was a randomized, double-blind,
placebo-controlled clinical trial of ATL/TV1102. Patients received
either ATL/TV1102 or placebo injections subcutaneously at a dose of
200 mg three times a week for the first week and twice weekly over
additional 7 weeks after which they were monitored for additional 8
weeks. Assessment was done using monthly MRI brain scans. 77 patients
were enrolled in the trial, which was conducted at multiple trial
sites across six European countries. The goal of the trial was to
obtain preliminary evidence of ATL/TV1102's effectiveness in reducing
MS-related MRI brain lesions and assess its safety profile.
In the primary endpoint of the study, ATL/TV1102 showed a
significant 54.4% reduction in cumulative number of new active MRI
lesions on weeks 4, 8 and 12 (p=0.01).
In addition, patients taking ATL/TV1102 experienced a 65% reduced
cumulative number of Gadolinium (Gd)-enhancing lesions on weeks 4, 8,
and 12 (p=0.0053). ATL/TV1102 was also effective in significantly
reducing T1-enhancing lesion volume by 84% at week 12.
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 (greater than 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 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.
The companies plan to present the results of this study at future
scientific meetings.
About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological
disability in young adults. It is estimated that 400,000 people in the
United States are affected by this disease, and that over two million
people are affected worldwide. MS is a progressive, demyelinating
disease of the central nervous system affecting the brain, spinal cord
and optic nerves.
Patients with MS may experience physical symptoms and/or cognitive
impairments, including weakness, fatigue, ataxia, physical
dysfunction, bladder and bowel problems, sensory effects, and visual
impairment. MS also has a significant impact on the sufferers' social
functioning and overall quality of life.
About ATL/TV1102
ATL/TV1102 is a 2nd generation antisense drug discovered by Isis
Pharmaceuticals Inc. (NASDAQ: ISIS) and licensed to ANP. Antisense
drugs block specifically disease-causing proteins from being produced
by interacting with their intended target based on information in the
genetic code. ATL/TV1102 is a second generation anti-sense inhibitor
of CD49d, a subunit of VLA-4 (Very Late Antigen-4), and is currently
in Phase IIa clinical trials as a treatment for MS. In inflammation,
white blood cells (leukocytes) move out of the bloodstream into the
inflamed tissue, for example, the 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 (Myers
et al. J Neuroimmunol 160, p12-24, 2005).
About Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 20 pharmaceutical companies in the world and is the
world's leading generic pharmaceutical company. The Company develops,
manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health
pharmaceutical products. Over 80 percent of Teva's sales are in North
America and Europe.
About Antisense Therapeutics
Antisense Therapeutics Limited (ASX: ANP) is an Australian
publicly listed biopharmaceutical drug discovery and development
company. Its mission is to create, develop and commercialize antisense
pharmaceuticals for large unmet markets. ANP has two drugs in
development and two drugs in pre-clinical research. ATL/TV1102
(injection) is in the advanced stages of a Phase IIa trial as a
potential treatment of multiple sclerosis. ATL1103 is a
second-generation antisense drug designed to lower blood IGF-I levels
and is entering pre-clinical development as a potential treatment for
acromegaly and vision disorders. ATL/TV1102 (inhaled) is at the
pre-clinical research stage as a potential treatment for asthma.
ATL1101 is a second-generation antisense drug at the pre-clinical
research stage being investigated as a potential treatment for
prostate cancer. ATL/TV1102 has been licensed to Teva Pharmaceutical
Industries Ltd.
Copaxone(R) (glatiramer acetate injection) is indicated for the
reduction of the frequency of relapses in patients with RRMS.
Teva Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements. Such statements
are based on management's current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could cause
Teva's future results, performance or achievements to differ
significantly from the results, performance or achievements expressed
or implied by such forward-looking statements, including statements
relating to the results of the ATL/TV1102 Phase IIa study and the
potential efficacy, tolerability and marketability of ATL/TV1102.
Additional risks relating to Teva and its business are discussed in
Teva's Annual Report on Form 20-F and its other filings with the U.S.
Securities and Exchange Commission. Forward-looking statements speak
only as of the date on which they are made and the Company undertakes
no obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.
Elana Holzman, 972 (3) 926-7554
or
Teva North America
Kevin Mannix, 215-591-8912
or
Antisense Therapeutics Ltd
Mark Diamond, 61 (3) 9827 8999
Copyright Business Wire 2008
