Grafix® Manuscript Reporting Positive Outcomes of Multicenter Chronic Complex Wounds with Exposed Tendon and Bone Clinical T...
August 04 2016 - 4:34PM
Osiris Therapeutics, Inc. (NASDAQ:OSIR), a leading cellular
regenerative medicine company focused on developing and marketing
products to treat conditions in wound care, orthopaedics and sports
medicine, announced today that the manuscript from its multicenter
prospective post-market clinical trial using Grafix was accepted
for publication in the International Wound Journal, is now
available online and will appear in an upcoming issue of the
journal.
About the Trial (Protocol 310)
Patients between 18 and 85 years of age with
confirmed type 1 or type 2 diabetes and with chronic complex
diabetic foot wounds that extended through the dermis and into the
subcutaneous tissue with evidence of exposed muscle, tendon, bone,
and/or joint capsule were considered for this study. Ulcers had to
be able to accommodate up to three 5 cm x 5 cm pieces of Grafix.
Patients were excluded from the trial if the ulcer had any evidence
of active infection at screening. Patients received treatment with
Grafix weekly for up to 16 weeks. The primary endpoint measured
100% granulation of wound by 16 weeks as determined by the
investigator. Secondary endpoints included complete wound closure
rates, time to 100% granulation, number of applications, and
percent wound area reduction at 4 weeks, 8 weeks, 12 weeks, and 16
weeks. 31 patients were enrolled, and 27 completed the study. The
patient group had significant co-morbidity, with over 80% having
hypertension, over 60% being current or former smokers, 55% having
heart disease and 45% having had a previous partial amputation. The
mean wound area was 14.6 cm2 with mean duration of 7.5 months, and
67.7% of patients failed advanced wound therapies prior to Grafix.
For patients completing the protocol, the primary endpoint, 100%
wound granulation by week 16, was met by 96.3% of patients in a
mean of 6.8 weeks. Complete wound closure occurred in 59.3% (mean
9.1 weeks). Osiris Therapeutics partnered with CPC Clinical
Research, an Academic Clinical Research Organization (CRO), who was
responsible for data management and pharmacovigilance services. The
protocol was submitted to clinicaltrials.gov (Reference #
NCT02260609).
About Grafix®
Grafix is a cryopreserved placental membrane
comprised of an extracellular matrix (ECM) rich in collagen, growth
factors and viable cells native to the tissue. Grafix is processed
using Osiris' proprietary BioSmart™ technology; it is flexible and
conforming and designed for application directly to hard-to-treat
acute and chronic wounds, including but not limited to diabetic
foot ulcers, venous leg ulcers and thermal burns.
About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia,
Maryland, is a world leader in researching, developing and
marketing regenerative medicine products that improve health and
lives of patients and lower overall healthcare costs. Having
developed the world’s first approved stem cell drug, the company
continues to advance its research and development in biotechnology
by focusing on innovation in regenerative medicine – including
bioengineering, stem cell research and viable tissue based
products. Osiris has achieved commercial success with
products in orthopaedics, sports medicine and wound care, including
BIO4®, Cartiform®, Grafix®, TruSkin ™ and Stravix™.
Osiris, Grafix, and Cartiform are registered
trademarks of Osiris Therapeutics, Inc.; TruSkin and Stravix are
trademarks of Osiris Therapeutics, Inc. BIO4 ® is a trademark
of Howmedica Osteonics Corp. More information can be found on the
company's website, www.Osiris.com. (OSIR-G)
Forward-Looking Statements
This press release contains forward-looking
statements. Forward-looking statements include statements about our
expectations, beliefs, plans, objectives, intentions, assumptions
and other statements that are not historical facts. Words or
phrases such as "anticipate," "believe," "continue," "ongoing,"
"estimate," "expect," "intend," "may," "plan," "potential,"
"predict," "project" or similar words or phrases, or the negatives
of those words or phrases, may identify forward-looking statements,
but the absence of these words does not necessarily mean that a
statement is not forward-looking. Examples of forward-looking
statements may include, without limitation, statements regarding
any of the following: our product development efforts; our clinical
trials and anticipated regulatory requirements, and our ability to
successfully navigate these requirements; the success of our
product candidates in development; status of the regulatory process
for our biologic drug candidates; implementation of our corporate
strategy; our financial performance; our product research and
development activities and projected expenditures, including our
anticipated timeline and clinical strategy biologic drug candidates
and marketed Biosurgery products (including Grafix, Stravix,
TruSkin, BIO4 and Cartiform); our cash needs; patents, trademarks
and other proprietary rights; the safety and ability of our
products and potential products to treat disease; our ability to
supply a sufficient amount of our marketed products or product
candidates and, if approved or otherwise commercially available,
products to meet demand; our costs to comply with governmental
regulations; our plans for sales and marketing; our plans regarding
facilities; types of regulatory frameworks we expect will be
applicable to our products and potential products; and results of
our scientific research. Forward-looking statements are subject to
known and unknown risks and uncertainties and are based on
potentially inaccurate assumptions that could cause actual results
to differ materially from those expected or implied by the
forward-looking statements. Our actual results could differ
materially from those anticipated in forward-looking statements for
many reasons, including the factors described in the section
entitled "Risk Factors" in our Annual Report on Form 10-K and other
Periodic Reports filed on Form 10-Q, with the United States
Securities and Exchange Commission. Accordingly, you should not
unduly rely on these forward-looking statements. We undertake no
obligation to publicly revise any forward-looking statement to
reflect circumstances or events after the date of this press
release or to reflect the occurrence of unanticipated events.
For additional information, please contact:
Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com
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