Teva & ANP Announce That ATL/TV1102, a Novel Drug for the Treatment of Relapsing Remitting Multiple Sclerosis (RRMS), Demonstrat
30 June 2008 - 9:45AM
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�, 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.
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