BioMS Medical cleared by FDA to initiate pivotal phase III multiple sclerosis trial
EDMONTON, Jan. 19 /CNW/ - BioMS Medical Corp (TSX: MS), a leading
developer of products for the treatment of multiple sclerosis (MS), announced
today that it has received clearance from the United States Food and Drug
Administration (FDA) of its Investigational New Drug Application (IND) for the
initiation of a pivotal phase III clinical trial to investigate the use of
MBP8298 as a treatment for patients with secondary progressive MS.
"The clearance to proceed with a phase III trial in the U.S. is a
significant step towards bringing MBP8298 to the worldwide market," said Kevin
Giese, President and CEO of BioMS Medical. "There are approximately 400,000
Americans with MS and close to 50% of patients have secondary progressive MS.
Between the U.S. initiative and the on-going pivotal phase III trial in Canada
and Europe, we are successfully executing our global development plan for
MBP8298."
The IND allows the commencement of a pivotal phase III secondary
progressive MS clinical trial in the US and has been granted on the basis of
satisfying FDA criteria regarding preclinical, chemistry, manufacturing and
safety data from the completed and ongoing clinical studies for MBP8298.
MAESTRO-03 Phase III US Trial
The pivotal phase III clinical trial in the US, named MAESTRO-03 (A
Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy
and Safety of MBP8298 in subjects with Secondary Progressive Multiple
Sclerosis), will be evaluating MBP8298 for the treatment of secondary
progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind
study enrolling approximately 510 patients who will be administered either
MBP8298 or placebo intravenously every six months for a period of two years.
The primary clinical endpoint for the trial is defined as a statistically and
clinically significant increase in the time to progression of the disease as
measured by the Expanded Disability Status Scale (EDSS), in patients with
HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are
HLA-DR2 and/or HLA-DR4 positive).
About MBP8298 - Novel Mechanism of Action
In MS patients, the body's immune system inappropriately attacks the
myelin coating around the nerves in the brain and spinal column, whereas
healthy people are otherwise "tolerant" of such common body components. The
proposed mechanism of action of MBP8298 is, by design, to re-introduce such a
state of "tolerance" to a critical portion of the nerve's Myelin Basic Protein
that is an immunological site of attack in many MS patients. This is
accomplished by the I.V. injection of MBP8298 every six months.
Phase II and long-term follow-up treatment of MS patients with MBP8298,
recently published in the European Journal of Neurology showed that MBP8298
safely delayed the median time to disease progression for five years in
progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.
MAESTRO-01 Trial
The MAESTRO-01 pivotal phase II/III, multi-center, double-blind,
placebo-controlled trial is currently being conducted at more than 50 sites
across Canada and Europe and will enroll approximately 550 patients who will
be administered either MBP8298 or placebo intravenously every six months for a
period of two years. The trial is designed to evaluate the safety and efficacy
of MBP8298 in patients with secondary progressive MS. The primary clinical
endpoint for the trial is defined as a statistically and clinically
significant increase in the time to progression of the disease as measured by
the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or
HLA-DR4 immune response genes. Time to disease progression in patients with
other HLA-DR types will be assessed separately as an exploratory arm of the
same study.
To date the trial has successfully passed six safety reviews by its
independent Data Safety Monitoring Board.
About Multiple Sclerosis
Multiple sclerosis (MS) is thought to affect as many as 2.5 million
people worldwide, including approximately 75,000 in Canada, 400,000 in the
United States and over 450,000 in Western Europe. MS is a progressive disease
of the central nervous system, characterized initially by episodes of
paralysis, blindness, sensory disturbances and cognitive impairment. Almost
half of all MS patients have the secondary progressive form of the disease.
Webcast
An audio webcast of Mr. Kevin Giese, President and CEO of BioMS Medical,
discussing this release will be available at www.biomsmedical.com starting on
Monday, January 22, 2007. The replay of the webcast will be available for 90
days at www.biomsmedical.com.
About BioMS Medical Corp.
-------------------------
BioMS Medical is a biotechnology company engaged in the development and
commercialization of novel therapeutic technologies. BioMS Medical's lead
technology, MBP8298, is for the treatment of multiple sclerosis and it has two
pivotal phase III clinical trials for SPMS patients, MAESTRO-01 in Canada and
Europe and MAESTRO-03 in the United States. It additionally has a Phase II
MINDSET-01 trial in Europe for RRMS patients. For further information please
visit our website at www.biomsmedical.com.
This news release may contain certain forward-looking statements that
reflect the current views and/or expectations of BioMS Medical with respect to
its performance, business and future events. Such statements are subject to a
number of risks, uncertainties and assumptions. Actual results and events may
vary significantly.
For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax,
E-mail: rgiese@biomsmedical.com, Internet: www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail:
jsmith@equicomgroup.com; Mr. Barry Mire, Investor Relations, Phone: (514)
939-3989, E-mail: bmire@renmarkfinancial.com
developer of products for the treatment of multiple sclerosis (MS), announced
today that it has received clearance from the United States Food and Drug
Administration (FDA) of its Investigational New Drug Application (IND) for the
initiation of a pivotal phase III clinical trial to investigate the use of
MBP8298 as a treatment for patients with secondary progressive MS.
"The clearance to proceed with a phase III trial in the U.S. is a
significant step towards bringing MBP8298 to the worldwide market," said Kevin
Giese, President and CEO of BioMS Medical. "There are approximately 400,000
Americans with MS and close to 50% of patients have secondary progressive MS.
Between the U.S. initiative and the on-going pivotal phase III trial in Canada
and Europe, we are successfully executing our global development plan for
MBP8298."
The IND allows the commencement of a pivotal phase III secondary
progressive MS clinical trial in the US and has been granted on the basis of
satisfying FDA criteria regarding preclinical, chemistry, manufacturing and
safety data from the completed and ongoing clinical studies for MBP8298.
MAESTRO-03 Phase III US Trial
The pivotal phase III clinical trial in the US, named MAESTRO-03 (A
Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy
and Safety of MBP8298 in subjects with Secondary Progressive Multiple
Sclerosis), will be evaluating MBP8298 for the treatment of secondary
progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind
study enrolling approximately 510 patients who will be administered either
MBP8298 or placebo intravenously every six months for a period of two years.
The primary clinical endpoint for the trial is defined as a statistically and
clinically significant increase in the time to progression of the disease as
measured by the Expanded Disability Status Scale (EDSS), in patients with
HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are
HLA-DR2 and/or HLA-DR4 positive).
About MBP8298 - Novel Mechanism of Action
In MS patients, the body's immune system inappropriately attacks the
myelin coating around the nerves in the brain and spinal column, whereas
healthy people are otherwise "tolerant" of such common body components. The
proposed mechanism of action of MBP8298 is, by design, to re-introduce such a
state of "tolerance" to a critical portion of the nerve's Myelin Basic Protein
that is an immunological site of attack in many MS patients. This is
accomplished by the I.V. injection of MBP8298 every six months.
Phase II and long-term follow-up treatment of MS patients with MBP8298,
recently published in the European Journal of Neurology showed that MBP8298
safely delayed the median time to disease progression for five years in
progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.
MAESTRO-01 Trial
The MAESTRO-01 pivotal phase II/III, multi-center, double-blind,
placebo-controlled trial is currently being conducted at more than 50 sites
across Canada and Europe and will enroll approximately 550 patients who will
be administered either MBP8298 or placebo intravenously every six months for a
period of two years. The trial is designed to evaluate the safety and efficacy
of MBP8298 in patients with secondary progressive MS. The primary clinical
endpoint for the trial is defined as a statistically and clinically
significant increase in the time to progression of the disease as measured by
the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or
HLA-DR4 immune response genes. Time to disease progression in patients with
other HLA-DR types will be assessed separately as an exploratory arm of the
same study.
To date the trial has successfully passed six safety reviews by its
independent Data Safety Monitoring Board.
About Multiple Sclerosis
Multiple sclerosis (MS) is thought to affect as many as 2.5 million
people worldwide, including approximately 75,000 in Canada, 400,000 in the
United States and over 450,000 in Western Europe. MS is a progressive disease
of the central nervous system, characterized initially by episodes of
paralysis, blindness, sensory disturbances and cognitive impairment. Almost
half of all MS patients have the secondary progressive form of the disease.
Webcast
An audio webcast of Mr. Kevin Giese, President and CEO of BioMS Medical,
discussing this release will be available at www.biomsmedical.com starting on
Monday, January 22, 2007. The replay of the webcast will be available for 90
days at www.biomsmedical.com.
About BioMS Medical Corp.
-------------------------
BioMS Medical is a biotechnology company engaged in the development and
commercialization of novel therapeutic technologies. BioMS Medical's lead
technology, MBP8298, is for the treatment of multiple sclerosis and it has two
pivotal phase III clinical trials for SPMS patients, MAESTRO-01 in Canada and
Europe and MAESTRO-03 in the United States. It additionally has a Phase II
MINDSET-01 trial in Europe for RRMS patients. For further information please
visit our website at www.biomsmedical.com.
This news release may contain certain forward-looking statements that
reflect the current views and/or expectations of BioMS Medical with respect to
its performance, business and future events. Such statements are subject to a
number of risks, uncertainties and assumptions. Actual results and events may
vary significantly.
For further information: Tony Hesby, Ryan Giese, Corporate
Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax,
E-mail: rgiese@biomsmedical.com, Internet: www.biomsmedical.com; James Smith,
Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail:
jsmith@equicomgroup.com; Mr. Barry Mire, Investor Relations, Phone: (514)
939-3989, E-mail: bmire@renmarkfinancial.com


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