PolarityTE Submits Investigational New Drug Application for SkinTE® in Chronic Cutaneous Ulcers
July 26 2021 - 8:00AM
Business Wire
PolarityTE, Inc. (Nasdaq: PTE) today announced the
submission of an investigational new drug application (IND) to the
United States Food and Drug Administration (FDA) seeking
authorization to commence a clinical trial to evaluate its SkinTE
product for the proposed indication of treatment of chronic
cutaneous ulcers. SkinTE is PolarityTE’s human cellular and
tissue-based product derived from a patient’s own skin.
PolarityTE included in its IND submission data accumulated when
SkinTE was used clinically and sold commercially from 2017-2021
pursuant to FDA’s stated period of enforcement discretion for
certain human cells, tissues, and cellular and tissue-based
products under Section 361 of the Public Health Service Act (361
HCT/Ps). Five separate clinical trials and multiple published case
series additionally serve as the basis for PolarityTE to pursue an
IND for the clinical evaluation of SkinTE as a potential biologic
therapeutic.
Prior clinical experience with SkinTE included in the IND was
observed in patients with wounds that caused substantial impact to
their daily life, were progressing towards permanent morbidity, had
no available therapy, were life threatening, and previously failed
other treatments. Wounds closed with SkinTE have exhibited
significant improvement after SkinTE application (e.g., avoidance
of amputation after failure of treatment alternatives). Thus,
PolarityTE believes that preliminary clinical evidence suggests
SkinTE could ameliorate a number of serious conditions caused by
chronic cutaneous ulcers.
PolarityTE expects to receive feedback related to this IND
submission from the FDA within approximately 30 days. This could
result in an accepted IND or, if FDA raises questions regarding
certain aspects of the Company’s IND, correspondence from FDA
(i.e., information requests and potentially a clinical hold if
information requests or other issues are unresolved) after which
PolarityTE would work with FDA in an effort to resolve any
outstanding issues. The Company plans to take all necessary steps
as it works towards achieving an accepted IND and expects to
commence its first clinical trial under the IND soon after
acceptance by FDA.
Responses and feedback from the FDA can vary widely, and
PolarityTE notes that other companies transitioning 361 HCT/Ps to
the biologics regulatory pathway have experienced a variety of
outcomes ranging from INDs accepted as submitted to responses and
clinical holds from FDA requiring an interactive process with the
Agency to obtain an accepted IND.
The Company deems this submission as a significant milestone in
the pursuit of a Biologic License Application (BLA) and a key
development in PolarityTE’s transition to a clinical-stage
development company. David Seaburg, Chief Executive Officer,
commented, “Chronic cutaneous ulcers are a major burden on the US
healthcare system, and impact millions of patients while costing
the healthcare system billions of dollars each year.” Mr. Seaburg
continued, “Based on our prior experience, we believe that SkinTE
represents a promising potential treatment for patients suffering
from these types of wounds, and we are deeply committed to working
expeditiously towards the initiation of clinical trials under this
IND to support a BLA.”
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. PolarityTE’s
products, including SkinTE, are in the development stage, and are
not approved or available for clinical use. Learn more at
www.PolarityTE.com – Welcome to the Shift®.
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, future clinical studies, 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.
POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES
SELF and WELCOME TO THE SHIFT are registered trademarks of
PolarityTE, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210726005157/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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