BioWorld International Correspondent
ZICHRON YA'AKOV, Israel - Treatment of nearly 300 burn victims with Debrase Gel Dressing engineered from pineapple stems by MediWound Ltd. averted lengthy and painful debridement excisional surgery with dramatically lower mortality, company officials said.
The results prompted the European Community to grant orphan drug status to the Yavne, Israel-based company's product about two months ago, said Lior Rosenberg, a burn specialist at the Soroka Hospital in BeerSheva and the chief medical officer of MediWound who supervised the studies.
Some victims had deeply disfiguring burns, such as a young worker who slipped into a vat of 700-degree molten zinc.
Phase IIb trials are beginning at 15 burn centers, six in the U.S. and nine in Europe, in patients with deep partial thickness or full thickness thermal burns.
The trial, being monitored by Inveresk Research International (IRI) in Glasgow, Scotland, will evaluate the safety and enzymatic debriding efficacy of Debrase in hospitalized patients compared with surgical treatment. The trial is anticipated to conclude by the end of 2003.
Rosenberg noted that in most cases, a single four-hour application digested the necrotic tissue into a gelatinous mass that wiped away, allowing clean, faster healing with less scarring. In deeper burns, the wound bed is made graft-ready without the high complication or contamination risks associated with mechanical surgical debridement.
MediWound CEO Marian Gorecki told BioWorld International, "Debrase targets an unmet clinical need that was recognized by receiving orphan drug designation. This assures us exclusivity of the product for 10 years from the date of marketing approval, an attractive growth and investment opportunity for potential big-pharma partners."
Debrase is well suited for immediate treatment of severe home- and work-related accidents as well as situations with large-scale casualties, said MediWound Chairman Avri Havron.
"The uniqueness of the preparation lies mainly in the patented extraction process that assures enzymatic activity with high specificity and selectivity for denatured human skin proteins, followed by purification and manufacturing using proprietary industrial biotechnological and pharmaceutical methods, in MediWound's new GMP facility in Yavne," Havron said.
MediWound is a portfolio company of Clal Biotechnology Industries Ltd. in Tel Aviv, which owns 80 percent of the start-up that was established in February 2001.
Ophir Shahaf, Clal Biotechnology's vice president of business development, told BioWorld International, "We have invested $10 million in MediWound. The company has lots of solid data and has great prospects. We have already started negotiations with several major foreign biopharmas."