DGAP-News: Elanix Biotechnologies AG / Key word(s): Research Update/Study results
27.12.2017 / 08:00
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Elanix’s Partner Transwell Biotech Completes Phase I of Phase I/II Clinical Trial with Progenitor Cell Treatment for Skin Graft Wounds
– No product-related adverse events found in 28 day safety evaluation
– Phase II to begin in Q1 2018 in Taiwan and Japan
Nyon, Switzerland and Berlin, Germany, 27 December, 2017 — Elanix Biotechnologies AG (FRA: ELN), a developer of tissue regeneration products and specialty cosmetics in dermatology and gynecology, announced today that partner Transwell Biotech Co., Ltd, subsidiary of Easywell Biomedicals, has completed the phase I-stage of the phase I/II studies with TWB-103 in adults with skin graft donor site wounds (DSW). TWB-103 is a novel product developed by Transwell Biotech that combines a proprietary hydrogel with cryopreserved cells derived from the skin fibroblast progenitor cells provided by Elanix.
The phase I/II trial is randomized and placebo controlled. While patients in the treatment group receive both hydrogel and cells, those in the control group receive only hydrogel. Without un-blinding, preliminary 28 days data have been acquired from placebo and cell-treated groups. No treatment related adverse effects were reported except one case of itchiness associating with secondary dressing. DSW from all patients were found to be healed on day 7 or 10 follow-up visit, with the exception of one patient who missed their day 10 visit and were found healed on day 14.
“Our partners, Transwell Bio, are progressing swiftly with the clinical evaluation of TWB-103 in acute wound healing, a product based on our progenitor cell technology combined with the proprietary technology of TWB. These initial safety results are promising and we look forward to starting the efficacy studies in early 2018,” stated Tomas Svoboda, CEO of Elanix Biotechnologies.
The Phase II part of the study will be conducted in Taiwan at the Tri-Service General Hospital in Taipei as well as the Tokyo Medical University Hospital and the Nippon Medical School Hospital in Japan. The primary objective of the study is healing time from DSW creation to 100% re-epithelialization. Recruitment will begin in Q1 2018.
Elanix develops and commercializes tissue regeneration products for acute wound care, dermatological and gynecological applications, and provides services in cell technologies. The company was founded in 2012 as a spin-out from the University Hospital of Lausanne (CHUV), Switzerland, to commercialize a patented human 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 human cell banks with vast quantities of cells.
Elanix has its registered office in Berlin, Germany, with an office in Wiesbaden, Germany, and operational headquarters in Nyon, Switzerland. It is listed in the Regulated Market on the Frankfurt Stock Exchange under the symbol ELN.F. For more information and updates, visit www.elanixbiotechnologies.com.
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27.12.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
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|Company:||Elanix Biotechnologies AG|
|Listed:||Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf|
|End of News||DGAP News Service|