Download Japan`s Bioventures Today — M`s Science Corporation

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JAPAN
Japan’s Bioventures Today —
M’s Science Corporation
* This article is contributed by JAIC Asia Holdings Pte. Ltd. as part of a collaboration with World Scientific Publishing Co. Pte. Ltd.
Background of M’s Science
M’s Science Corporation (“M’s Science”) is a venture company established
in November 2000 with the mission to “create new drugs by state-of-the-art
research to improve human health.” M’s Science was founded by Dr Shiro
Mita, former director and general manager of research and development
at Santen Pharmaceutical Co., Ltd. The company develops promising drug
candidates discovered internally or licensed from other companies.
Product Pipeline of M’s Science
M’s Science currently has two major products: SA4503, a sigma receptor
agonist for treatment of depression and enhancement of stroke recovery;
and HF10, a spontaneous mutant of the herpes simplex virus for cancer
treatment.
Control
SA4503
Fig. 1 SA4503 enhances neurite outgrowth
of primary neuronal cultures.
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SA4503
SA4503 is a highly selective, small molecule sigma-1 receptor agonist
indicated for stroke recovery, major depression, Alzheimer’s disease, and
multiple sclerosis. The sigma-1 receptor is known to play a key role in the
regeneration of and functional recovery from damage to the central nervous
system. SA4503 is highly selective for the sigma-1 receptor and shows little
affinity for other receptors, ion channels, or enzymes. Its neuromodulatory
and cognitive enhancing activities further increase the opportunity for novel
treatments of several central nervous system disorders.
Post-stroke Recovery
Stroke is a serious medical condition with significant mortality, functional
impairment, and disability in survivors. Existing treatments for ischemic
stroke include thrombolytic treatment, which is able to reduce damage to
brain tissue; this treatment, however, needs to be administered within a very
short time span after the stroke occurrence in order to be effective and safe.
SA4503, on the other hand, demonstrated high efficacy in animal models
when administered even two days after experimental stroke. In addition,
SA4503 demonstrated efficacy in experimental models of traumatic brain
injury and multiple sclerosis.
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Depression Therapy
Depression is one of the most common central nervous system disorders
affecting 5% to 20% of the overall population. Antidepressant drugs currently
on the market target monoaminergic transmitter mechanisms, and they
belong to either selective serotonin reuptake inhibitors (SSRIs) or selective
norepinephrine reuptake inhibitors (SNRIs). Their slow onset of action
and adverse effects leave significant room for novel drugs with different
modes of action. As cortical and hippocampal shrinkage are often observed
in depression, regeneration of nervous tissue is believed to be a promising
new approach to the treatment of depression. SA4503 promotes survival and
neurite outgrowth of primary neurons and has displayed efficacy in several
models of depression. Most importantly, it was efficacious in a chronic mild
stress model with rapid onset of action.
Clinical Development
In early December, M’s Science obtained approval for a Phase IIa study of
SA4503 for the indication of post-stroke recovery in the UK. This doubleblind, placebo-controlled Phase IIa study will enroll 60 stroke patients and
test SA4503’s safety and efficacy. Also the Phase IIa study of SA4503 for
treatment of major depression was approved in Europe in September 2007.
The company will enroll approximately 150 patients for this international
study.
Fig. 2 How HF10 works on tumor cells.
HF10
HF10 is an attenuated, spontaneous mutant of herpes
simplex virus type 1 (HSV1) that is free from exogenous
genes and has effective anticancer activity. HF10 was first
discovered by Professor Yukihiro Nishiyama, Nagoya
University School of Medicine, Japan. M’s Science has
been collaborating with Professor Nishiyama to develop
HF10 as an anticancer agent. HF10 has a high potential
to become an effective oncolytic virotherapeutic agent
due to its efficacy and safety, as well as its relative ease
of production.
When administered, HF10 infects both tumor
cells and normal cells, but replicates only in tumor
cells because of their specific cell cycle condition. This
replication eventually leads to lysis of the tumor cells, which in turn triggers
the activation of the patients’ immune response against the tumor cells,
thus improving the ability to recognize tumor cells as foreign. On the other
hand, as most humans have antibodies against the herpes virus, HF10 does
not spread systemically beyond the administration site, tumor tissues, and
its surrounding area. This characteristic of HF10 further ensures the safety
of this treatment
Clinical Development
M’s Science is currently pursuing clinical trials of HF10 for the treatment of
head and neck cancer at Nagoya University School of Medicine, Japan. The
company was granted a patent for HF10 from the United States Patent and
Trademark Office in September 2007, and is preparing to start a Phase I/II
trial in early 2008. The company plans to pursue with HF10 other indications
such as melanoma, breast cancer, and disseminated peritoneal metastases.
38 ■ Volume 12 > Number 2 > 2008
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Market Overview of Post-stroke Recovery Drug
Every year, about 780 000 people in the US and millions globally experience
a stroke. In Japan, the figure is approximately 150 000 annually. Stroke is
the third most common cause of death after cancer and cardiac diseases. It
has a high mortality rate, and is likely to cause complications and disabilities
that seriously affect the daily lives of patients. In Japan, the total number of
stroke patients who suffer from these complications, including half-paralysis
and speech disorders, is currently estimated at 1.23 million.
At present, there are only a few drugs on the market for treatment of
stroke and these are primarily used in the acute phase of the disease. The
thrombolytic enzyme Activase® from Genentech Inc. works by dissolving
the blood clot in the brain artery that was formed during the stroke.
Mitsubishi Tanabe Pharma Corporation’s Radicut®, which is approved in
Japan, controls the emission of free radicals generated during the stroke and
thereby reduces tissue damage.
M’s Science’s SA4503 is the only post-stroke recovery drug in the world
that works on sigma receptors, and that has the potential for a significantly
expanded time window of treatment initiation.
Contact Details:
M’s Science Corporation
Address:Kobe International Business Center Bldg.,
5-5-2, Minatojima-Minamimachi,
Chuo-ku, Kobe City,
Hyogo 650-0047, Japan
Tel:
+81 78 388 6000
Fax:
+81 78 388 6001
Email: [email protected]
URL:
www.m-sci.com/e/index.html/
www.asiabiotech.com
Future of M’s Science
Given the high potential of SA4503 to become a blockbuster
drug, with expected annual sales of 120 billion yen in the US
and 360 billion yen worldwide when approved, M’s Science
strives to accelerate the development of SA4503 and has
targeted its market introduction in 2012. The company is also
continuing the development of HF10, and plans to further
expands its pipeline with other innovative drugs by utilizing
its proprietary technologies and expertise. ■
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