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®, 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 (>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®
(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.
Bookmarken
