Abeona Therapeutics Announces Presentation of EB-101 Data at Society for Investigative Dermatology Annual Meeting
May 08 2019 - 08:30AM
Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader
in gene and cell therapy, today announced that long-term follow up
data from a completed Phase 1/2 study evaluating EB-101 for the
treatment of recessive dystrophic epidermolysis bullosa (RDEB) will
be presented at the 77th Annual Meeting of the Society for
Investigative Dermatology (SID), being held May 8-11 in Chicago.
The data will be presented by Stanford University researcher
Shaundra Eichstadt, M.D. in two forums at the meeting, as detailed
below.
As previously reported, these data showed that
three years after treatment with EB-101, a majority of RDEB
patients had durable wound healing. Notable improvements were also
reported in outcomes associated with wound healing, including
patient reported reductions in pain and itching. No serious
treatment-related adverse events were observed at three years, and
no replication competent virus was present at any time point.
Genetically corrected autologous keratinocyte
epidermal grafts improve wound healing and patient reported
outcomes in patients with recessive dystrophic epidermolysis
bullosa (RDEB)Selected e-Poster Discussion IThursday, May 9, 11:15
a.m. – 12:15 p.m. CTPoster Session III Saturday, May 11, 12:45 –
2:45 p.m. CT
About EB-101EB-101 is an
investigational, autologous, gene-corrected cell therapy poised to
enter late-stage development for the treatment of recessive
dystrophic epidermolysis bullosa (RDEB), a rare connective tissue
disorder without an approved therapy. Treatment with EB-101
involves using gene transfer to deliver COL7A1 genes into a
patient’s own skin cells (keratinocytes) and transplanting them
back to the patient to enable normal Type VII collagen expression
and skin function. In the U.S., Abeona holds Regenerative Medicine
Advanced Therapy, Breakthrough Therapy, and Rare Pediatric
designations for EB-101 and Orphan Drug designation in both the
U.S. and EU.
About Recessive Dystrophic Epidermolysis
BullosaRecessive dystrophic epidermolysis bullosa, or
RDEB, is a rare connective tissue disorder without an approved
therapy in which patients suffer with severe epidermal wounds that
bring pain, itching, and widespread complications impacting the
length and quality of their lives. People with RDEB have a defect
in the COL7A1 gene, leaving them unable to produce Type VII
collagen that helps anchor the dermal and epidermal layers of the
skin.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical
company developing gene and cell therapies for serious diseases.
The Company’s clinical programs include EB-101, its autologous,
gene-corrected cell therapy for recessive dystrophic epidermolysis
bullosa, as well as ABO-102 and ABO-101, novel AAV9-based gene
therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS
IIIB). The Company’s portfolio of AAV9-based gene therapies also
features ABO-202 and ABO-201 for CLN1 disease and CLN3 disease,
respectively. Its preclinical assets include ABO-401, which uses
the novel AIM™ AAV vector platform to address all mutations of
cystic fibrosis. Abeona has received numerous regulatory
designations from the FDA and EMA for its pipeline candidates and
is the only company with Regenerative Medicine Advanced Therapy
designation for two investigational therapies (EB-101 and ABO-102).
For more information, visit www.abeonatherapeutics.com.
Forward Looking StatementThis
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 regarding our pipeline including the
potential use of investigational product EB-101 in the treatment of
recessive dystrophic epidermolysis bullosa (RDEB) based upon
pre-clinical data. We have attempted to identify forward
looking statements by such terminology as “may,” will,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” and
similar expressions.
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: continued interest in our rare disease portfolio,
our ability to initiate and enroll patients in clinical trials, 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 reports filed by the Company with the Securities and Exchange
Commission. The Company undertakes no obligation to revise
the forward-looking statements or 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:Sofia
WarnerSenior Director, Investor RelationsAbeona Therapeutics+1
(646) 813-4710swarner@abeonatherapeutics.com
Media Contact:Scott
SantiamoDirector, Corporate CommunicationsAbeona Therapeutics+1
(718) 344-5843ssantiamo@abeonatherapeutics.com
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