Orgenesis Meets With The Paul-Ehrlich Institute
WHITE PLAINS, N.Y.--(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
Vered Caplan, Chairperson
KEYWORDS: United States North America New York Middle East Israel
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