"As we launch StrataGraft commercially, we are continuing our clinical development activities, which includes the StrataSOMA clinical trial, with the goal of seeking to expand the approved indication to include other patient populations with severe burns," said
Each year, approximately 40,000 patients in
About the StrataSOMA Clinical Trial
The open-label randomized, within-patient controlled multicenter Phase 1/2a clinical trial is evaluating the efficacy, safety and tolerability of StrataGraft overlay of meshed autograft in the investigational treatment of patients with full-thickness thermal burns. The study is expected to enroll 40 adults ages 18 to 75 with a 2% to 49% total body surface area (TBSA) thermal burn, including areas of full-thickness injury clinically indicated for surgical excision and autografting appropriate for protocol-defined treatment areas.3 All study participants will serve as their own control. On each participant, similar wounds will be identified as treatment sites and will be randomized to receive either meshed autograft or meshed autograft with StrataGraft. Primary outcomes include complete wound closure without additional autografting at Month 2 and durable wound closure without additional autografting at Month 12. The trial is underway in several locations in the
StrataGraft is a viable, bioengineered, allogeneic, cellularized scaffold product derived from keratinocytes grown on gelled collagen containing dermal fibroblasts. StrataGraft is designed to deliver viable cells to support the body's own ability to heal. StrataGraft contains metabolically active cells that produce and secrete a variety of growth factors and cytokines. Growth factors and cytokines are known to be involved in wound repair and regeneration. The product is designed with both dermal and epidermal layers composed of well-characterized human cells. StrataGraft is intended to be applied in appropriate aseptic conditions, such as the operating room, and can be sutured, stapled or secured with a tissue adhesive.
The FDA granted StrataGraft orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act. At the time of approval, the FDA awarded Stratatech Corporation, a Mallinckrodt company, a Priority Review Voucher (PRV).
StrataGraft® is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
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Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the
Cautionary Statements Related to Forward-Looking Statements
This release includes forward-looking statements concerning StrataGraft, including clinical trial plans and potential outcomes, its potential impact on patients, and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Vice President, Finance and Investor Relations
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2 Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA. Treating pain on skin graft donor sites: review and clinical recommendations. J Trauma Acute Care Surg. 2017;83(5):954-964
3 ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04765202. Accessed
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