Osiris Therapeutics, Inc. Announces Peer-Reviewed Publication Comparing the Efficacy of Viable Cryopreserved Placental Membra...
27 Agosto 2018 - 5:30PM
Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative
medicine company focused on developing and marketing products for
wound care, orthopedics, and sports medicine, announced today that
a new peer-reviewed manuscript entitled “A multicenter, randomized,
single-blind trial comparing the efficacy of viable cryopreserved
placental membrane to human fibroblast-derived dermal substitute in
the treatment of chronic diabetic foot ulcers” has been published
in the Wound Repair and Regeneration and is available online
https://onlinelibrary.wiley.com/doi/10.1111/wrr.12645
Dermagraft® (1) is a bioengineered human fibroblast-derived
dermal substitute product that has been on the U.S. market for more
than 15 years (2, 3). Grafix® is a cryopreserved placental
tissue allograft that has been developed using a proprietary
cryopreservation method. This method allows the retention of intact
matrix, growth factors and cells native to placental tissue.
Prior clinical studies have shown the safety and efficacy of both
Grafix and Dermagraft when used in the treatment for chronic DFUs
in their respective trials (4, 5). The study’s objective was to
compare clinical outcomes and product cost between Grafix and
Dermagraft as an adjunct to standard of care (SOC) in the treatment
of chronic DFUs in a prospective, multicenter, single-blind
study.
The study’s objective was to compare clinical outcomes and
product cost between Grafix and Dermagraft as an adjunct to
standard of care (SOC) in the treatment of chronic DFUs in a
non-inferiority prospective, multicenter, single-blind study. Sixty
two patients were evaluable in the per protocol (PP) population: 31
Grafix patients and 31 Dermagraft patients. There were no
significant differences between treatment cohorts with an exception
of longer wound duration and more plantar wound locations for the
Grafix group. The average wound size was 7.12 cm2 in the Grafix
group and 5.70 cm2 (p=0.732) in the Dermagraft group. Both patient
cohorts had noteworthy comorbidities, such as heart disease (92.1%
of Grafix patients and 94.6% of Dermagraft patients) and prior
amputations (55.5% of Grafix patients and 54.1% of Dermagraft
patients).
Key clinical outcomes include:
- The study met its primary endpoint: Grafix was not inferior to
Dermagraft for the proportion of patients achieving complete wound
closure (48.4% of Grafix patients and 38.7% of Dermagraft patients,
a non-inferiority criterion of the lower limit of 90% confidential
interval greater than -15% was met) when the
established-for-Dermagraft-treatment- regimen of up to 8 weekly
application was used for both skin substitutes.
- For a subset of patients with typical DFUs (≤ 5 cm2), closure
at the end of treatment was achieved in 81.3% (13/16) of Grafix
patients, compared to 37.5% (6/16) of Dermagraft patients
(p=0.0118).
- For DFUs of less or equal to 5 cm2, mean per-patient product
cost for Grafix patients was $3,846 compared to $7,968 for
Dermagraft patients (p < 0.0001).
“With growing number of wound care products and development of
new technologies, comparative research in prospective randomized
studies has tremendous value,” said Dr. Charles Ananian, DPM, who
is the lead study investigator. “Wound-care providers like myself
and my colleagues may utilize results of this study when selecting
what we believe is the best treatment option for the patient.”
- Dermagraft® is a registered trademark of Organogenesis, Inc.
(Canton, MA).
- Naughton G, Mansbridge J, Gentzkow G. A metabolically active
human dermal replacement for the treatment of diabetic foot ulcers.
Arti Organs 1997;21:1203-10.
- Hart CE, Loewen-Rodriguez A, Lessem J. Dermagraft: use in the
treatment of chronic wounds. Adv Wound Care (New Rochelle)
2012;1:138-41.
- Lavery LA, Fulmer J, Shebetka KA, et al. The efficacy and
safety of Grafix ® for the treatment of chronic diabetic foot
ulcers: results of a multi-centre, controlled, randomised, blinded,
clinical trial. Int Wound J. 2014;11:554-60.
- Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic
Foot Ulcer Study Group. The efficacy and safety of Dermagraft in
improving the healing of chronic diabetic foot ulcers: results of a
prospective randomized trial. Diabetes Care 2003;26:1701-05.
About Grafix
Grafix is a cryopreserved placental membrane that retains the
extracellular matrix, growth factors, endogenous cells, including
neonatal mesenchymal stem cells, and fibroblasts of the native
tissue, all of which are beneficial in supporting natural wound
repair. The membrane is a flexible and conforming wound cover
designed for direct application 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,
researches, develops, manufactures and commercializes regenerative
medicine products intended to improve the health and lives of
patients and lower overall healthcare costs. We have achieved
commercial success with products in orthopedics, sports medicine
and wound care, including the Grafix product line, Stravix®, BIO4®
and Cartiform®. We continue to advance our research and development
by focusing on innovation in regenerative medicine, including the
development of bioengineered stem cell and tissue‑based products.
Osiris®, Grafix®, Grafix Prime®, and Cartiform® are our trademarks.
BIO4® is a trademark of Howmedica Osteonics Corp., a subsidiary of
Stryker Corporation. More information can be found on the Company’s
website, www.Osiris.com. (OSIR-G)
Forward-Looking Statements
Statements herein relating to the future of Osiris Therapeutics,
Inc. and the ongoing research and development of our products are
forward-looking statements. Osiris Therapeutics, Inc. cautions that
these forward looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include those identified under the
heading “Risk Factors” in the Osiris Therapeutics Inc. Annual
Report on Form 10-K for the years ended December 31, 2017, 2016 and
2015 and Quarterly Report on Form 10-Q for the quarter ended March
31, 2018, as filed with the Securities and Exchange Commission
(SEC). We caution investors not to place considerable reliance on
the forward-looking statements contained in this press release.
Examples of forward-looking statements may include, without
limitation, statements regarding the anticipated efficiencies and
advantages of products and the likelihood of customer clinical
adoption of any new products. Although well characterized in
scientific literature and studies, preservation of tissue
integrity, including cells, may not be indicative of clinical
outcome. Accordingly, you should not unduly rely on these
forward-looking statements. You are encouraged to read our filings
with the SEC, available at sec.gov, for a discussion of these and
other risks and uncertainties. The forward-looking statements in
this press release speak only as of the date of this document, and
we undertake no obligation to update or revise any of the
statements. Our business is subject to substantial risks and
uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
For additional information, please
contact:
Diane SavoieOsiris Therapeutics, Inc.(443)
545-1834 OsirisPR@Osiris.com
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