Home' Forge : Vol 2 No 1 Contents 92
now take three years, according to
reports in The Japan Times1.
The new laws provide an opportunity
for Regeneus to fast-track the clinical
trial and potential approval of its
allogeneic stem-cell therapy, Progenza,
to treat osteoarthritis and infammatory
musculoskeletal conditions in Japan.
'There is a substantial market in Japan to
treat osteoarthritis through non-surgical
procedures, such as joint injections, and
the potential to launch and develop
Progenza there before taking it to the
United States and Europe,' says Martin.
Regeneus has spent the past 18 months
identifying the right clinical and
marketing partners in Japan to start a
Phase II trial and potentially manufacture
the product there.
Following encouraging preclinical trials,
a Phase I trial for Progenza started in
the third quarter of 2015 in Sydney. The
trial is expected to conclude in the third
quarter of 2016, and pave the way for a
Phase II trial in Japan.
By identifying and selecting the most
appropriate cells, the CNBP technology
could result in more targeted cell
therapies. Martin believes that the
technology has signifcant commercial
opportunities in its own right: Regeneus
intends to develop analysis kits for the
research and diagnostics markets, and
license them to stem-cell researchers
worldwide. The global cell-isolation
market is expected to reach US$5.1 billion
by 2019, from US$2.5 billion in 2014.
Strong product pipeline
Regeneus' technology underpins a
promising portfolio of human and
animal product platforms. In human
products, Regeneus is developing
Progenza and cancer vaccine RGSH4K,
a clinical-stage autologous cancer
immunotherapy that uses the patient's
own tumour as source material for
a vaccine, coupled with a bacterial
adjuvant for immune recognition.
Regeneus believes that this clinical-stage
technology could target a global market
for solid tumours worth US$33 billion.
The company is developing CryoShot
Canine and CryoShot Equine to treat
osteoarthritis in dogs and horses
respectively. Both technologies use
allogeneic cells from a donor and
are targeting global markets with
the companion animal market worth
Regeneus' Kvax canine cancer vaccine
technology uses a dog's own cells to
develop a cancer vaccine, for a market
estimated at US$550 million.
Regeneus expects to announce a
manufacturing and development
partner for Progenza in Japan, and has
commenced enrolment for the second
patient cohort for the technology's
Phase I trial. Several key data reports for
its animal technologies are due in 2016.
Consistent, measured progress
The Sydney-based company has come
a long way since its formation in 2007
and its initial public offering on the
ASX in 2013, which raised $10.5 million.
Regeneus' technology can now potentially
be applied to multiple platforms across
musculoskeletal disorders, tumours and
infammatory skin conditions.
The portfolio is being de-risked with
all product candidates in clinical trials,
and Regeneus is developing its research
across human and animal health. It has
a good record of achieving its milestones
each year, patenting intellectual property,
building valuable research collaborations,
and fnding new applications and
markets for its technologies.
Regeneus' animal products, the most
clinically and commercially advanced in
its portfolio, could provide signifcant
revenue to fund the development of
Progenza and RGSH4K, and enable
Regeneus to take these technologies
further through the trial process,
creating more shareholder value.
'We believe Regeneus is well
positioned in the rapidly emerging
field of regenerative medicine,' says
Martin. 'We have been developing our
core technology for almost a decade,
and building extensive knowledge and
relationships in regenerative medicine.
If we are successful, we will have
several products coming to market in
the next few years as the market for
regenerative medicine takes off, first
Regeneus shares traded at 9.5 cents
in January 2015. Edison Investment
Research in December 2015 valued
Regeneus at 51 cents a share.
To learn more about Regeneus, visit
regeneus.com.au. To learn more about
the Centre of Excellence for Nanoscale
BioPhotonics, visit cnbp.org.au.
1 'Regenerative medicine to get boost from
deregulation in Japan,' The Japan Times,
September 3, 2015.
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