Orgenesis Approved for EUR 2.015.000 Grant to Support
Development of Its Type 1 Diabetes Program in Europe
Orgenesis SPRL, a subsidiary of Orgenesis Inc. (OTCQB: ORGS),
a leader in the emerging fields of cellular therapy and regenerative
medicine, today announced that it has received the formal approval
from the Walloon Region, Belgium (Service Public of Wallonia, DG06)
for a EUR 2,015 million support program for the research and
development of a potential cure for Type 1 Diabetes.
The Financial support is composed of a EUR 1.085.000 (70% of
budgeted costs) grant for the industrial research part of the
research program and a further recoverable advance of EUR 930.000
(60% of budgeted costs) of the experimental development part of the
research program. The grants will be paid to Orgenesis over a period
of approximately 3 years. The grants are subject to certain
conditions respecting our conducting the work in the Walloon Region,
our own investment in these projects and certain other conditions.
“We are extremely appreciative of the Walloon Region’s willingness
to support the Orgenesis European activity with this grant,” said
Vered Caplan, Chairperson and CEO of Orgenesis. “This approval, once
more justifies the decision by Orgenesis to set up our development
and manufacturing activity in the Walloon Region. This location has
become a central hub for cell therapy in Europe, where we have found
advanced development and manufacturing partnerships and service
providers, such as Pall Corporation, through its recently purchased
subsidiary ATMI, and MaSTherCell, a contract developer specializing
in cell therapy products, and industrial and financial support by
the Wallonian Minister of the Innovation and Research.”
Orgenesis is pioneering work in developing technology to
successfully reprogram human liver cells into glucose-responsive,
fully functional Insulin Producing Cells (IPCs). The objective of
the European program is to continue the development of a cGMP
(Current Good Manufacturing Practice) and implement it on a
high-efficiency industrial scale, which will enable Orgenesis to
obtain functional Insulin Producing Cells (IPC) in large quantities
from the livers of patients suffering from Type 1 Diabetes.
“Orgenesis has demonstrated tremendous innovation in its research
and development efforts to date,” said Michel Charlier, DGO6 General
Inspector. “Their therapies hold great promise in how Type 1
Diabetes will be treated around the world. Orgenesis represents the
type of innovative company we seek to support and foster in the
Walloon Region.”
About DG06 (Service Public of Wallonie) DG06 Economy – Employment –
Research is a branch of the Administration of Wallonia, Belgium.
Through its Technology Development Department, the Walloon Region
has set up several attractive incentives to boost regional
innovation and research, to support companies, from start-ups to
well-established enterprises in their way to innovation and
successful development.
About Orgenesis, Inc. Orgenesis is a development stage company that
is committed to curing Type 1 Diabetes. In pursuit of this goal, the
Company is developing a novel technology that combines cellular
therapy and regenerative medicine. Through a proprietary biologic
process called “cellular trans-differentiation,” Orgenesis has
proven that, when exposed ex vivo to certain pancreatic
transcription factors and in specific sequence, human adult liver
cells can be transformed into fully functional, beta cell-like
insulin producing cells (IPCs). After ex vivo expansion, the IPCs
are re-infused via the portal vein. In pre-clinical models of Type 1
Diabetes (Non-Obese Diabetic mice), the re-introduced IPCs remain in
the liver, effectively respond to glucose challenge and successfully
maintain glycemic homeostasis. In the same NOD model, the implanted
IPCs were not subject to auto-immune attack or cellular ablation.
Orgenesis plans to initiate P1/2 trials in the next 12-16 months.
For more information visit: www.orgenesis.com.
Notice Regarding Forward-Looking Statements This news release
contains “forward-looking statements” which are not purely
historical. Such forward-looking statements include, among other
things, the expectations of management that our regeneration
technology can be developed as therapeutic treatment for diabetes
which could become a cure for diabetes; and that our patent will
protect our intellectual property; and that we will receive the full
value of grants and advances from DG06 as announced. No assurance
can be given that any of the events anticipated by the
forward-looking statements will occur or, if they do occur, what
benefits Orgenesis will obtain from them. Actual results could
differ from those projected in any forward-looking statements due to
numerous factors, including, among others, the potential failure of
development candidates to advance through preclinical studies or
demonstrate safety and efficacy in clinical testing; the ability to
pass clinical trials so as to move on to the next phase; our ability
to retain key employees; our ability to finance development and
operations and to comply with all conditions necessary to receive
the announced grants; our ability to satisfy the rigorous regulatory
requirements for new medical procedures; and competitors may develop
better or cheaper alternatives to our products. These
forward-looking statements are made as of the date of this news
release, and we assume no obligation to update the forward-looking
statements, or to update the reasons why actual results could differ
from those projected in the forward-looking statements. Investors
should refer to the risk factors disclosure outlined in our periodic
reports filed from time-to-time with the Securities and Exchange
Commission.