| |
 |
 |
 |
 |
 |
 |
 |
November 21, 2002
Notice on
the Completion of the Pilot Plant
for Manufacturing HVJ Envelope Vectors |
 |
|
|
We are pleased to report that a pilot plant for
manufacturing HVJ envelope vectors (hereinafter referred to
as, "HVJ-E non-viral vectors") has been completed
in our Ikeda Laboratory.
This plant complies with the "Good Manufacturing Practice"
(GMP) standards for production and quality control of medical
and pharmaceutical products. For the HVJ-E non-viral vectors,
production technologies have already been established in relation
to gene analysis for studying gene functions, and Ishihara Sangyo
Kaisha, Ltd. has released their reagents for research. The completion
of our plant enables development of the HVJ-E non-viral vectors
as drug delivery systems for medical and pharmaceutical products
starting in the next fiscal year. These delivery systems are
the technologies for delivering an agent to the affected parts
of the body.
The HVJ-E non-viral vectors refer to a technology that uses
only the membrane of Hemagglutinating Virus of Japan (HVJ; also
known as the Sendai Virus) discovered in Japan during the 1950s,
with all the genetic expressions removed, enabling the HVJ-E
non-viral vectors to fuse cells with the membrane (cellular
fusion), which significantly improves the adoption efficiency
and safety of the product.
Existing vectors are mainly categorized into viral and non-viral
vectors. Although viral vectors possess good adoption efficiency
due to infective properties of (original) viruses, some safety
problems remain unresolved. Non-viral vectors with fatty membranes,
on the other hand, are safe, but their adoption efficiency is
diminished. The HVJ-E non-viral vector is a technology that
eliminates the problems of existing vectors, avaling them to
a wide range of applications, and have the potential of becoming
the world's leading vectors.
For medical applications, the HVJ-E non-vrial vectors can be
used as advanced pharmaceuticals through use of biopolymers
including gene-related medecines, nucleic acid and gene related
medicines. Furthermore, these vectors can also be used as a
drug delivery system (DDS) to improve absorption of low molecular
compounds and other conventional drugs in the body.
While we proceed with the research for the vector applications
to genetic therapy and protein related drugs, as well as other
advanced pharmaceuticals, our company is planing to develop
pharmaceuticals with high lesion delivery efficacy applying
the vectors to the anti-tumor agents with severe side effects
due to systemic administration. For that purpose, we have joined
forces with many domestic and overseas pharmaceutical companies,
and we plan to start clinical tests within a few years.
We would like to draw your attention to the fact that development
of the HVJ-E non-viral vectors has received the support of the
Ministry of Economy, Trade and Industry, as well as the support
of the ministry-affiliated New Energy and Industrial Technology
Development Organization, and National Institute of Advanced
Industrial Science and Technology, an independent administrative
body. Furthermore, Professor Yasufumi Kaneda of the Faculty
of Medicine at Osaka University has filed an application for
basic patents for the vector in major countries around the world,
and has transferred the patent rights to our company. |
|
|
