PolarityTE Announces Diabetic Foot Ulcer Trial Met Primary and Secondary Endpoint
May 10 2021 - 08:00AM
Business Wire
Reports Peer-Reviewed Publication of Interim
Results from Diabetic Foot Ulcer Trial in International Wound
Journal
PolarityTE, Inc. (Nasdaq: PTE) today announced
preliminary topline data demonstrating that a multi-center
randomized controlled trial evaluating treatment of Diabetic Foot
Ulcers with SkinTE® plus standard of care (SOC) vs SOC alone
(NCT03881254) met the primary endpoint of wound closure at 12 weeks
and secondary endpoint of Percent Area Reduction (PAR) at 12 weeks.
100 patients were evaluated across 13 sites with 50 patients
receiving SkinTE plus SOC and 50 patients receiving SOC alone.
Primary Endpoint: 70% (35/50) of patients receiving
SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of
patients receiving SOC alone—p=0.00032
Secondary Endpoint: Percent Area Reduction (PAR) at 12
weeks was significantly greater for the SkinTE plus SOC treatment
group (84.4%) vs SOC alone (53.5%)—p=0.00024
The results from this fully-enrolled 100 patient trial will be
issued via a poster presentation entitled, “Topline Results: 100
Patient Randomized Controlled Trial to Evaluate the Treatment of
Diabetic Foot Ulcers with a Novel Autologous Heterogeneous Skin
Construct” and available to those attending the Symposium on
Advanced Wound Care (SAWC) Spring Conference held virtually May
10-14, 2021. PolarityTE also plans to discuss the topline results
during the Company’s upcoming earnings call scheduled for May 13,
2021 at 4:30 p.m. Eastern Time. The conference call can be accessed
by dialing 1-800-377-1217 (U.S. and Canada) or +44 (0)330 027 2386
(International) with confirmation code 231666 and referencing
“PolarityTE First Quarter 2021 Earnings Call”. A webcast of the
conference call can be accessed by using the link below.
Earnings Call Webcast – CLICK HERE
PolarityTE is pleased to announce that two additional SkinTE
presentations will be available for those attending the SAWC
virtual event:
- A case series selected for oral presentation on May 12th from
3:40-4:40 p.m. Central Time entitled, “Use of an Autologous
Heterogeneous Skin Construct in the Treatment of Late-Effect
Radiation Wounds”
- An accepted poster entitled, “Closure of Stage IV Pressure
Injuries with an Autologous Heterogeneous Skin Construct”
PolarityTE today also reported the recent publication of a
peer-reviewed manuscript in the International Wound Journal
reporting the interim analysis results of the Company’s Diabetic
Foot Ulcer study: Armstrong DG, Orgill DP, Galiano R, et al. A
multicentre, randomised controlled clinical trial evaluating the
effects of a novel autologous, heterogeneous skin construct in the
treatment of Wagner one diabetic foot ulcers: Interim analysis. Int
Wound J. 2021; 1–12 (https://doi.org/10.1111/iwj.13598). These data
demonstrated that the AHSC+SOC 12-week closure rates were
significantly greater than the SOC alone closure rates (72% vs 32%,
P = .005).
Nikolai Sopko, MD, PhD commented, “We are incredibly pleased to
report these topline data, which are consistent with the data we
observed from the protocol-specified interim analysis that was
recently published in the International Wound Journal. We want to
thank the patients who participated in the trial, our Principal
Investigator, Dr. David Armstrong, all of the investigators in the
trial, and the healthcare providers and clinical trial teams who
navigated the immense challenges of Covid-19 to ensure that our
patients remained safe and this trial was completed.” Dr. Sopko
continued, “Most of all, we are excited about the clinical outcomes
and believe that these results speak to the immense clinical
promise that SkinTE holds for patients suffering from the
significant unmet needs associated with chronic wounds. As we look
towards our IND submission and an eventual BLA, we take great pride
in these data and look forward to presenting the full data set in
due course.”
About PolarityTE®
PolarityTE is focused on transforming the lives of patients by
discovering, designing, and developing a range of regenerative
tissue products and biomaterials for the fields of medicine,
biomedical engineering and material sciences. Rather than
manufacturing with synthetic and foreign materials within
artificially engineered environments, PolarityTE manufactures
products from the patient's own tissue and uses the patient's own
body to support the regenerative process. From a small piece of
healthy autologous tissue, the company creates an easily
deployable, dynamic, and self-propagating product designed to
regenerate the target tissues. PolarityTE's innovative methods are
intended to promote and accelerate growth of the patient's tissues
to undergo a form of effective regenerative healing. Learn more at
www.PolarityTE.com – Welcome to the Shift®.
About SkinTE®
SkinTE is a human cellular and tissue-based product derived from
a patient’s own skin (autologous) intended for the repair,
reconstruction, replacement, or supplementation of skin tissue.
Aseptic surgical procedures and handling during skin harvest, wound
preparation, and SkinTE deployment are mandatory.
SkinTE is currently marketed as a human cell, tissue, and
cellular and tissue-based product regulated solely under Section
361 of the Public Health Service Act (PHS Act) and 21 CFR Part 1271
(i.e., as a 361 HCT/P). PolarityTE plans to file an investigational
new drug application (IND) with FDA followed by a biologics license
application (BLA) to have SkinTE regulated as a biologic under the
federal Food Drug & Cosmetic Act and Section 351 of the PHS Act
(i.e., as a 351 HCT/P), and will propose to FDA a plan for
transitioning SkinTE from a 361 HCT/P to a 351 HCT/P.
Forward Looking Statements
Certain statements contained in this release are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. They are generally
identified by words such as "believes," "may," "expects,"
"anticipates," "intend," "plan," "will," "would," "should" and
similar expressions. Readers should not place undue reliance on
such forward-looking statements, which are based upon the Company's
beliefs and assumptions as of the date of this release. The
Company's actual results could differ materially due to the impact
of the COVID-19 pandemic and FDA regulatory matters, which cannot
be predicted, and the risk factors and other items described in
more detail in the "Risk Factors" section of the Company's Annual
Reports and other filings with the SEC (copies of which may be
obtained at www.sec.gov). Subsequent events and developments may
cause these forward-looking statements to change. The Company
specifically disclaims any obligation or intention to update or
revise these forward-looking statements as a result of changed
events or circumstances that occur after the date of this release,
except as required by applicable law. Our actual results could
differ materially due to risk factors and other items described in
more detail in the "Risk Factors" section of the Company's Annual
Reports and other filings with the SEC (copies of which may be
obtained at www.sec.gov).
POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES
SELF and WELCOME TO THE SHIFT are trademarks or registered
trademarks of PolarityTE, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210510005092/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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