Full Press Release Details
Orgenesis Approved for 2.015.000 Euros Grant to Support
Development of its Type 1 Diabetes Program in Europe
Gosselies, Belgium Nov. 24, 2014 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 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 1,085,000 euros (70% of
budgeted costs) grant for the industrial research part of the research program
and a further recoverable advance of 930,000 euros (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)
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
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.