SOURCE: Orgenesis Inc.

Orgenesis Inc.

November 23, 2015 07:00 ET

Lyfebulb and Orgenesis Form Strategic Collaboration With Focus on Delivering a Patient-Centered Practical Cure for Type 1 Diabetes

NEW YORK, NY--(Marketwired - Nov 23, 2015) - Lyfebulb, an organization dedicated to improving the quality of life for people living with chronic disease, has entered into an advisory and consulting agreement with Orgenesis Inc. (OTCQB: ORGS). Within the context of the agreement, Lyfebulb will help Orgenesis identify and incorporate insights that are unique and important to Type 1 Diabetes patients into the design and conduct of the company's clinical development plans. Additionally, Lyfebulb will advise the company on its commercialization strategies to ensure optimal patient access and market acceptance if and when its products are approved for clinical use. 

Lyfebulb's team, which consists of Karin Hehenberger, MD, PhD, and Anna Hehenberger, JD, shall provide these services to Orgenesis through close collaboration with the company's Board of Directors, Scientific Advisory Board and Senior Management.

"Orgenesis represents the type of company we seek to work with on all levels," Karin Hehenberger said. "We are thrilled to engage with this team in an effort to build strategic partnerships as they bring new regenerative medicine therapies to market that use the body's own liver cells to help free patients from insulin dependence."

The Orgenesis 'cellular trans-differentiation' technology is at the forefront of realizing the promise a practical cure for Type 1 Diabetes. The process involves trans-differentiating a particular adult cell type to then function as an adult cell of a different type. In this case, liver cells are trans-differentiated into pancreatic-like beta cells that function as fully mature, glucose-responsive, insulin-producing cells. The promise of liver-to-pancreas cellular trans-differentiation is to regenerate a Type 1 Diabetic patient's natural ability to regulate insulin production in response to blood glucose levels -- and to do so in a way that does not require concomitant immuno-suppressive or immuno-modulatory therapies.

"Lyfebulb is an extraordinary organization and we are honored to be associated with them and their mission," Vered Caplan, CEO of Orgenesis, said. "Lyfebulb closely aligns with our goals of helping to ease, if not erase, the burden of chronic disease. We hope to introduce new personalized and practical solutions for individuals struggling with chronic conditions such as Type 1 Diabetes."

In addition, Lyfebulb plans to host a Lyfebulb Connect Event with Orgenesis, scheduled for December 8, 2015 in New York City. Lyfebulb Connect Events enable emerging companies to gain exposure to Lyfebulb's patient community as well as Lyfebulb's extensive professional network. Lyfebulb Connect Events are an excellent opportunity for companies to present their products and research in an intimate setting before a diverse audience which includes patients, doctors and key opinion leaders, investors, as well as other companies. Lyfebulb's goal is to bring together people with chronic diseases, physicians, medical thought leaders and so forth in informative and relaxed environments to discuss chronic disease issues. For more information, visit www.lyfebulb.com.

About Lyfebulb
Lyfebulb is a patient-centric organization whose mission is to improve the quality of life for people living with chronic disease NOW. The goal is to connect people, inspire them to change behavior and impact their lives, with a Vision to invest in, and raise awareness for, solutions and products that help people manage their disease. We execute this Vision through our Lyfebulb Connect Events as well as online by growing our Lyfebulb Community, and function as a bridge between patients and industry through working directly with companies in advisory roles. Lyfebulb was founded by Dr. Karin Hehenberger, CEO of Lyfebulb, Riccardo Braglia, CEO of Helsinn Healthcare, and Dr. Stephen Squinto, Venture partner at Orbimed and co-founder of Alexion. Together, the three co-founders have nearly 75 years of experience in the healthcare sector. In addition to the founders, we have built a strong operational team augmented by a stellar executive board and experienced advisory board. For more information, please visit www.lyfebulb.com.

About Dr. Karin Hehenberger
Dr. Hehenberger is a health and wellness expert, with over 15 years of experience in the healthcare industry, ranging from executive positions with JNJ, JDRF, Eyetech, and most recently Coronado Biosciences, to partnership roles at private and public investments firms. Dr. Hehenberger trained as an MD and Ph.D. at the Karolinska Institute, Sweden, and did her post-doctoral fellowship at the Joslin Diabetes Center, Harvard Medical School. She is the founder and CEO of Lyfebulb, and also on the executive team at Immune Pharmaceuticals as Senior Vice President, Medical Affairs and Corporate Communications, responsible for the company's external communications and relationships with key opinion leaders, patient advocacy groups, media and investors.

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 back into a diabetic patient's liver. 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 US and EU within the next 12-18 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, 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.

Contact Information