Orgenesis Meets With The Paul-Ehrlich Institute
19 Novembre 2012 - 2:00PM
Business Wire
Orgenesis Inc. (OTCBB:ORGS) (“Orgenesis” or the “Company”), a
development-stage company with a novel therapeutic technology
dedicated to converting a patient’s own liver cells into
functioning insulin-producing cells as a treatment for diabetes,
announced today that it has recently held its first scientific
meeting with the Paul-Ehrlich Institute (“PEI”), completing another
important step toward initiating advanced stage trials of the
Company’s technology.
The PEI is an agency of the German Federal Ministry of Health,
responsible for all regulatory issues related to the development of
innovative therapies and advanced medicinal products in its home
country. The PEI also plays an important role in various
committees, working parties and expert groups at the European
Medicines Agency (“EMA”).
“This meeting was part of a parallel scientific advisory process
that we are engaging in with the U.S. Food and Drug Administration
and the EMA as we plan for the first in-human clinical trials of
our diabetes treatment product candidate,” said Jacob BenArie, CEO
of Orgenesis. “We are pleased with the positive reception that we
have received to date and look forward to continued dialogue with
the senior regulatory bodies.”
About Orgenesis Inc.
Orgenesis (OTCBB:ORGS) is a development stage company with a
novel therapeutic technology that employs a molecular and cellular
approach directed at converting a patient's own liver cells into
functional insulin producing cells, as a treatment for diabetes.
The Company believes that converting the diabetic patient's own
tissue into insulin-producing cells overcomes the problem of donor
shortage and removes the risk of transplant rejection. If
successful, this could mean the end of diabetes, as we now know it.
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 and that we can secure regulatory approval for our
procedures. 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 the Company will obtain from them.
Actual results could differ from those projected in any
forward-looking statements due to numerous factors. Such factors
include, among others, the inherent uncertainties associated with
new projects and development stage companies, which include,
without limitation, the potential failure of development candidates
to advance through preclinical studies or demonstrate safety and
efficacy in clinical testing and the ability to pass clinical
trials so as to move on to the next phase, our ability to retain
key employees and our ability to finance development or satisfy the
rigorous regulatory requirements for new medical procedures.
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.
On Behalf of the Board Orgenesis Inc.
Vered Caplan, Chairperson
Orgenesis (QX) (USOTC:ORGS)
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