Elanix Biotechnologies AG (“Elanix” - FSE: ELN), a developer of tissue regeneration and cosmetic products, announces that their licensed partner Transwell Biotechnology Ltd. (subsidiary of Easywell Biomedicals Ltd., Hsinchu, Taiwan) has received investigational new drug (IND) clearance from the US FDA to conduct combined Phase I/II clinical trial. The trial is titled "A phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (DSW)”, reference NCT02737748. The study will begin in Japan and Taiwan and will be coordinated by a noted contract research organization respectively Principal Investigator. In parallel, the trial will also be conducted in Japan under the supervision of the Principal Investigator Dr. Nakazawa Hiroshima at the Nihon University Hospital, Tokyo, Japan.
The study will compare safety and efficacy of TWB-103 (skin fibroblast progenitors as provided by Elanix Biotechnologies AG) add-on TegadermTM to standard of care TegadermTM (skin dressing) alone. Primary objectives are to evaluate the safety and efficacy of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding) respectively for Phase I+II in terms of the healing time from DSW creation to 100% re-epithelialization. Enrollment of patients in Taiwan and Japan is expected by Q2 2017.
Tomas J. Svoboda, BSc., MBA, CEO of Elanix Biotechnologies AG, explains why this study is important for Elanix: " This study with TWB-103 is one way to confirm the clinical relevance of our progenitor cells for acute wound care. The success of our strategic partners is paramount to achieve our objective to become a global player in regenerative medicine. “
Sean Chen, Ph.D., General Manager of Transwell Biotechnology Ltd., stresses the importance of Elanix: “We are pleased to be able to carry this unique cell therapy project into the clinical stage after years of careful planning, regulatory consultation and in-house hard-working. We are confident about our business strategy and the quality of our investigational product. We certainly appreciate the business partnership and continuous support from Elanix Biotechnologies AG, and we intend to carry on with this good partnership into our future product and business development."
“We are very appreciative to the Regenerative Medicine team of Easywell Biomedicals with respect to its diligent and dedicated work in developing Elanix progenitor cell-based novel technologies for tissue regeneration. This constitutes a major milestone in validating the leading science conducted at Elanix, Elanix Biotechnologies/Transwell Biotechnology strategic partnership and the outstanding capacity of Transwell Biotechnology to pursue efficient clinical development pathways in Asia. Elanix Biotechnologies will continue to provide support to Transwell Biotechnology for further development with the Taiwanese FDA and with the Japanese PMDA” Says Riccardo Nisato, Ph.D., MBA, General Manager Tissue Engineering Products Business Unit and Head of QA&RA at Elanix.
Elanix Biotechnologies AG (Frankfurt: ELN) develops and commercializes tissue regeneration products for acute wound care, dermatological and gynecological applications, and provides services in cell technologies. Cosmetic-based products are derived from animal tissue sources while tissue regeneration products for medical use are derived from human tissues. Elanix complies with appropriate legislations on cosmetics and medical applications in Switzerland and worldwide. The company was founded in 2013 as a spin-out from the Lausanne University Hospital (CHUV), Switzerland, to develop and commercialize medicinal products based on a patented progenitor cell technology. Progenitor cells are fully differentiated yet immunologically neutral cells that are very potent inducers of tissue growth and healing. Elanix owns GMP-certified Master and Working cell banks with vast quantities of cells of different cell types. The Company is headquartered in Nyon, Switzerland with offices in Potsdam and is listed on the Frankfurt stock exchange under the symbol ELN. For more information and updates, visit www.elanix-biotechnologies.com.
Transwell Biotechnologies ltd. based in Taipei City, Taiwan Ltd (now subsidiary of Easywell Biomedicals in 2016) focuses on regenerative medicine that involves the application of progenitor skin cells on wounds. The company develops and commercializes therapeutic and supporting care products for patients with various types and stages of wounds. The company provides wound-care therapy services during and after injury recovery. They also offer cell-based wound dressing products for burn and chronic wound treatments and technology in transdermal patches.
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This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Elanix Biotechnologies AG. This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States of America (the "United States"), Australia, Canada or Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful. The securities referred to in this announcement will not be and have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements under the U.S. Securities Act. Subject to certain exceptions, the securities referred to in this announcement may not be offered or sold in Australia, Canada or Japan, or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The offer and sale of the securities referred to in this announcement has not been and will not be registered under the U.S. Securities Act or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States.
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Last updated on: 08/11/2016
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