Abeona Therapeutics Announces Upcoming Data Presentations at the Society for Pediatric Dermatology 45th Annual Meeting
June 18 2020 - 7:30AM
Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader
in gene and cell therapy, today announced that two abstracts
related to its clinical program for recessive dystrophic
epidermolysis bullosa (RDEB) will be presented at the upcoming
Society for Pediatric Dermatology (SPD) 45th Annual Meeting, to be
held virtually during July 10-12, 2020. RDEB is a rare connective
tissue disorder without an approved treatment, in which patients
suffer from severe epidermal wounds that severely impact their
lives.
The first abstract features a more detailed examination than
previously disclosed of data on long-term pain relief following
durable healing of wounds in RDEB patients treated with EB-101 in a
Phase 1/2 study. Separately, a literature review on the clinical,
humanistic and economic burden of RDEB will be presented.
The posters will be presented by Jean Tang, M.D., Ph.D.,
Professor of Dermatology, Stanford University Medical Center and
Principal Investigator of the EB-101 pivotal Phase 3 VIITALTM
study, and M. Peter Marinkovich, M.D., Investigator on the VIITALTM
study and Bullous Disease Clinic Director, Stanford University
Medical Center. Details for the presentations are as follows:
Title: Durable Healing and Pain
Reduction in Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Following EB-101 Treatment of Large, Chronic
WoundsPresenter: Jean Tang, M.D.
Ph.D.Virtual Session Date: July 10-12, 2020
Title: The Full Burden of Recessive Dystrophic
Epidermolysis Bullosa (RDEB)Presenter: M. Peter
Marinkovich, M.D.Virtual Session Date: July 10-12,
2020
Following the conclusion of each virtual presentation, the
posters will be available on the “Events” page under the “Investors
& Media” section of Abeona’s website at
www.abeonatherapeutics.com.
More details about the programs for the SPD Annual Meeting are
available at https://pedsderm.net/meetings/annual-meeting/.
About EB-101EB-101 is an autologous,
gene-corrected cell therapy currently being investigated in the
pivotal Phase 3 VIITALTM study for the treatment of recessive
dystrophic epidermolysis bullosa (RDEB), a rare connective tissue
disorder without an approved therapy. The EB-101 VIITALTM study is
a multi-center, randomized clinical trial enrolling 10 to 15 RDEB
patients with approximately 30 large, chronic wound sites treated
in total. Treatment with EB-101 involves using gene transfer to
deliver COL7A1 genes into a patient’s own skin cells (keratinocytes
and its progenitors) and transplanting them back to the patient to
enable normal Type VII collagen expression and facilitate wound
healing. Abeona produces EB-101 for the VIITALTM study at its
fully-functional gene and cell therapy manufacturing facility in
Cleveland, OH. In a Phase 1/2a clinical trial, EB-101 provided
durable wound healing for RDEB patients lasting 2+ to 5+ years,
including for the largest, most challenging wounds that affect the
majority of the RDEB population. More information on the clinical
trials of EB-101 can be found at
https://www.abeonatherapeutics.com/clinical-trials/rdeb and
ClinicalTrials.gov.
About Recessive Dystrophic Epidermolysis
BullosaRecessive dystrophic epidermolysis bullosa (RDEB)
is a rare connective tissue disorder characterized by severe skin
wounds that cause pain and can lead to systemic complications
impacting the length and quality of life. People with RDEB have a
defect in the COL7A1 gene, leaving them unable to produce
functioning type VII collagen which is necessary to anchor the
dermal and epidermal layers of the skin. There is currently no
approved treatment for RDEB.
About Abeona Therapeutics Abeona Therapeutics
Inc. is a clinical-stage biopharmaceutical company developing gene
and cell therapies for serious diseases. Abeona’s clinical programs
include EB-101, its autologous, gene-corrected cell therapy for
recessive dystrophic epidermolysis bullosa in Phase 3 development,
as well as ABO-102 and ABO-101, novel AAV-based gene therapies for
Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB),
respectively, in Phase 1/2 development. The Company’s portfolio of
AAV-based gene therapies also features ABO-202 and ABO-201 for CLN1
disease and CLN3 disease, respectively. Abeona’s library of novel,
next-generation AIM™ capsids have shown potential to improve
tropism profiles for a variety of devastating diseases. Abeona’s
fully functional, gene and cell therapy GMP manufacturing facility
produces EB-101 for the pivotal Phase 3 VIITALTM study and is
capable of clinical and commercial production of AAV gene
therapies. For more information, visit
www.abeonatherapeutics.com.
Forward-Looking Statements This press release
contains certain statements that are forward-looking within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
and that involve risks and uncertainties. These statements include
statements about the Company’s clinical trials and its products and
product candidates, future regulatory interactions with regulatory
authorities, as well as the Company’s goals and objectives. We have
attempted to identify forward looking statements by such
terminology as “may,” “will,” “believe,” “estimate,” “expect,” and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances), which
constitute and are intended to identify forward-looking statements.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, numerous risks and uncertainties, including but not
limited to the potential impacts of the COVID-19 pandemic on our
business, operations, and financial condition, continued interest
in our rare disease portfolio, our ability to enroll patients in
clinical trials, the outcome of any future meetings with the U.S.
Food and Drug Administration or other regulatory agencies, the
impact of competition, the ability to secure licenses for any
technology that may be necessary to commercialize our products, the
ability to achieve or obtain necessary regulatory approvals, the
impact of changes in the financial markets and global economic
conditions, risks associated with data analysis and reporting, and
other risks as may be detailed from time to time in the Company’s
Annual Reports on Form 10-K and quarterly reports on Form 10-Q and
other periodic reports filed by the Company with the Securities and
Exchange Commission. The Company undertakes no obligation to revise
the forward-looking statements or to update them to reflect events
or circumstances occurring after the date of this presentation,
whether as a result of new information, future developments or
otherwise, except as required by the federal securities laws.
Investor Contact:Greg Gin VP, Investor
Relations Abeona Therapeutics +1 (646)
813-4709ggin@abeonatherapeutics.com
Media Contact:Scott Santiamo Director,
Corporate Communications Abeona Therapeutics +1 (718) 344-5843
ssantiamo@abeonatherapeutics.com
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