SOURCE: Orgenesis Inc.

Orgenesis Inc.

November 24, 2015 10:54 ET

Orgenesis and Biosequel Enter Collaboration Agreement for Conducting Clinical Trials for Type 1 Diabetes Treatment in Russia

GERMANTOWN, MD--(Marketwired - Nov 24, 2015) - Orgenesis Inc. (OTCQB: ORGS), a cell therapy and regenerative medicine company with a novel therapeutic technology dedicated to converting a patient's own cells into functioning insulin-producing cells as a treatment for diabetes, announced that it has signed a collaboration agreement with Russian company, Biosequel LLC. The two companies will collaborate on conducting clinical trials in Russia. The collaboration will commence with the opening of the new Yauza Medical Center on Nov. 24, 2015.

"We have searched the world over for a company as progressive and innovative as Orgenesis," said Dr. Vitaly Shabadash, Biosequel founder and practicing Israeli physician. "Orgenesis is on the cutting edge of medical development in driving the industry towards a practical cure for Type 1 Diabetes and we are honored to work with them in Russia to facilitate the human clinical trials in this country."

Orgenesis is an innovator in the technology of "cellular trans-differentiation." This process involves re-programming one adult cell type to function like an adult cell of a different type. Orgenesis is developing Autologous Insulin Producing Cells, which means a type 1 diabetic patient's own liver cells would be transformed into glucose-responsive insulin-producing liver cells in the hope of freeing the patient from insulin dependence.

"We are pleased that Biosequel has chosen to collaborate with us and make use of the unique research facilities at the new state-of-the-art Yauza Medical Center," said Vered Caplan, CEO of Orgenesis. "Biosequel has the right people and the resources to take our research to the next stage of clinical development and regulatory approvals."

About Orgenesis Inc.
Orgenesis is a cell therapy and regenerative medicine company that is committed to developing a cure for Type 1 Diabetes. In pursuit of this goal, the company has developed and patented a novel technology called "cellular trans-differentiation" that turns an insulin-dependent patient's own liver cells into functional insulin producing cells. 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 of the diabetic patient. 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 12-18 months. Orgenesis believes that converting the diabetic patient's own tissue into insulin-producing cells has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation. For more information, visit www.orgenesis.com.

Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" which are not purely historical and involve substantial risks and uncertainties. Such forward-looking statements include, among other things, the expectations of Orgenesis' management that our regeneration technology can be developed as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; that we can develop the technology to turn a small number of cells into a large number of cells; and that we will initiate Phase I and Phase II clinical trials in the near-term. 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 technology may not as well as expected, our ability to retain key employees; our ability to finance development and operations; 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, including the annual report on Form 10-K for the year ended November 30, 2014.

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