YAVNE, Israel, April 08, 2016 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announces that top-line data from a multicenter Phase 2 clinical study of the Company’s EscharEx® to treat chronic wounds will be presented in the Late-Breaking Session at the Spring Symposium on Advanced Wound Care (SAWC) 2016 taking place April 13-17, 2016 in Atlanta.
“We are excited that these positive data will be presented at SAWC Spring 2016 before an audience of the world’s leading wound care clinicians. The top-line data from this multicenter, international, prospective, randomized, vehicle-controlled, assessor-blinded Phase 2 trial are important because there has been a long-lasting, unmet medical need for an effective and rapid nonsurgical debridement treatment for chronic wounds. Debridement is a critical first step to facilitate wound management and is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound,” noted Gal Cohen, MediWound’s Chief Executive Officer.
“The incidence of complete debridement with EscharEx within up to 10 daily treatments was significantly higher and completed earlier compared with the control group, with an overall comparable safety profile. Results were even more prominent in the prospective subgroups of diabetic foot and venous leg ulcers, which is in line with the etiologies we are focused on based on the results of a comprehensive market research report we undertook. The topical debridement treatments currently on the market require daily application for weeks and months to achieve complete debridement. A post hoc analysis of our Phase 2 data with EscharEx showed that 93% of the wounds which completed debridement with EscharEx were debrided within 7 days after 4-5 applications on average,” added Mr. Cohen.
The poster highlighting the top-line results of the Phase 2 study of EscharEx to treat chronic wounds will be available for viewing Friday, April 15th and Saturday, April 16th from 7:30 a.m. to 6:00 p.m. local time. The study authors will present the data during the following session:
|Session:||Wound Healing Society's Poster Presentations|
|Title:||"Bromelain-based Enzymatic Debridement of Chronic Wounds: Top-Line Results of a Multicenter Phase 2 Trial"|
|Authors:||Y. Shoham, MD, Plastic and Reconstructive Surgery Department, Soroka University Medical Center, Beer Sheva, Israel; A. Shalom, M. D., Plastic and Reconstructive Surgery Department, Meir Medical Center, Kfar Saba, Israel; L. Rosenberg, MD, MediWound|
|Date/Time:||Friday, April 15 from 7:15 p.m. – 8:30 p.m.|
On February 3, 2016, MediWound announced the top-line results from the Phase 2 clinical trial of EscharEx to treat chronic wounds. A summary of those data can be found here.
About MediWound Ltd.
MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency as well as the Israeli and Argentinian Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns and was launched in Europe and Israel, with plans for a launch in Argentina. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues. For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to the regulatory authorizations and launch dates. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. In particular, you should consider the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2015 and information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
|Sharon Malka||Anne Marie Fields|
|Chief Financial and Operations Officer||Senior Vice President|