YAVNE, Israel, May 31, 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 a comprehensive review of injectable bromelain solution (IBS, or MWPC003) for the treatment of Dupuytren’s contracture (DC) was published in the May 2016 edition of the peer-reviewed journal Bone & Joint Research. The online version of the review article, “A new bromelain-based enzyme for the release of Dupuytren’s contracture,” can be accessed here.
IBS is an investigational sterile injectable drug containing a mixture of medical-grade proteolytic enzymes as also used in MediWound’s NexoBrid®, which is approved in Europe and other geographies for burn debridement. DC is a connective tissue disorder characterized by the thickening and contracture of the fibrous tissue layer underneath the skin of the palm and fingers that causes shortening and progressive digital flexion deformity. While open surgical or sharp needle cordotomy/fasciotomy has been the mainstay of treatment for DC, there has been recent interest in less invasive approaches, including enzymatic disruption by collagenase injection.1
Following the earlier pilot phase of the study, which confirmed with statistical significance the authors’ hypothesis that IBS would completely dissolve Dupuytren’s cords (Fisher Exact test p<0.0001), a second ex vivo study was conducted in 71 cords that were injected with IBS in descending doses. This study demonstrated that even very small doses of IBS can dissolve the pathological cord in more than 80% of cases. The Cochran-Armitage test supports the trend hypothesis (p=0.0021) indicating that the probability for cord dissolution increases as the dose increases.
According to the study authors, “This preliminary study demonstrates the ability of small doses of IBS to dissolve Dupuytren’s cord tissue ex vivo. Due to the efficacy demonstrated, the possibility for treatment with minute doses and volumes, as well as the characteristics of IBS anti-inflammatory potency, there is a strong case for continuing to a full-scale development programme.”
“Treatment with collagenase has certain advantages over traditional surgical methods, but high recurrence rates underscore the need for better therapies. The scientific rationale for MWPC003 to treat connective tissue disorders is based on its proteolytic properties, which allow it to dissolve the pathological cord even when using very small doses, and the potential of the reported anti-inflammatory/immunomodulatory activity of bromelain to reduce the high recurrence rate,” stated Prof. Lior Rosenberg, MD, Chief Medical Technology Officer of MediWound.
“We are enthusiastic about this opportunity as this preliminary study demonstrated statistically significant efficacy in a known and accepted connective tissue disorder model and supports additional new potential uses of our enzymatic technology. We are encouraged to generate the remaining data needed to support an Investigational New Drug (IND) application for MWPC003 in connective tissue disorders and thereafter embark on a clinical development program for this exciting opportunity,“ stated Gal Cohen, President and Chief Executive Officer of MediWound.
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.
MediWound's second innovative product, EscharEx® is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds and is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx® contains the same proteolytic enzyme technology as NexoBrid®, and benefits from the wealth of existing development data on NexoBrid®. In two Phase 2 studies, EscharEx® has demonstrated safety and efficacy in the debridement of chronic and other hard-to-heal wounds, within a few daily applications. 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, 2014 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.
|Contacts:||Anne Marie Fields|
|Sharon Malka||Senior Vice President|
|Chief Financial and Operations Officer||LHA|
1 Henry M. Dupuytren’s disease: current state of the art. Hand (N Y) 2014;9:1-8.