Ocugen, Inc. Announces Removal of Clinical Hold on Investigational New Drug Application for OCU200 Phase 1 Clinical Trial
09 Octubre 2024 - 5:30AM
Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies, biologics, and
vaccines, today announced that the U.S. Food and Drug
Administration (FDA) has lifted the clinical hold on the
investigational new drug application for the Phase 1 clinical trial
evaluating OCU200, a recombinant fusion protein consisting of
tumstatin and transferrin, for treating diabetic macular edema
(DME).
“We are excited to launch the Phase 1 clinical trial for OCU200,
which is designed to treat patients with DME,” said Dr. Arun
Upadhyay, Chief Scientific Officer and Head of Research &
Development at Ocugen. “Approximately 30 to 40% of DME patients are
refractive to current anti-VEGF therapies. OCU200 targets the
underlying disease mechanisms through the integrin pathway and
holds promise to provide benefits to all DME patients, including
non-responders to currently approved therapy.”
OCU200 possesses unique features that potentially enable it to
treat vascular complications of DME. Tumstatin is the active
component of OCU200 and binds to integrin receptors, which play a
crucial role in disease pathogenesis. Transferrin is expected to
facilitate the targeted delivery of tumstatin into the retina and
choroid and potentially help increase the interaction between
tumstatin and integrin receptors.
“I look forward to bringing OCU200 into the clinic and advancing
this important candidate in Ocugen’s portfolio for treating
blindness diseases,” said Dr. Huma Qamar, Chief Medical Officer at
Ocugen. “DME is becoming more prevalent as the number of people
with diabetes in the U.S. rises, making the condition even more
imperative to address.”
This is a multicenter, open-label, dose-ranging study with 3
cohorts in the dose-escalation portion assessing safety of OCU200
and in the fourth cohort a combination of OCU200 (MTD) with
anti-VEGF following sequential intravitreal administration.
DME is one of the most common vision-threatening diseases
occurring in people with diabetes and includes blurriness in vision
and progressive vision loss as the disease progresses.
Approximately 746,000 people in the United States are affected with
DME.
The Company intends to pursue additional indications for OCU200
to potentially treat diabetic retinopathy and wet age-related
macular degeneration, which combined affect nearly nine million
Americans.
About Ocugen, Inc.Ocugen, Inc. is a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies, biologics, and
vaccines that improve health and offer hope for patients across the
globe. We are making an impact on patients’ lives through
courageous innovation—forging new scientific paths that harness our
unique intellectual and human capital. Our breakthrough modifier
gene therapy platform has the potential to treat multiple retinal
diseases with a single product, and we are advancing research in
infectious diseases to support public health and orthopedic
diseases to address unmet medical needs. Discover more
at www.ocugen.com and follow us
on X and LinkedIn.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995, including, but not limited to, strategy,
business plans and objectives for Ocugen’s clinical programs, plans
and timelines for the preclinical and clinical development of
Ocugen’s product candidates, including the therapeutic potential,
clinical benefits and safety thereof, expectations regarding
timing, success and data announcements of current ongoing
preclinical and clinical trials, the ability to initiate new
clinical programs; statements regarding qualitative assessments of
available data, potential benefits, expectations for ongoing
clinical trials, anticipated regulatory filings and anticipated
development timelines, which are subject to risks and
uncertainties. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “proposed,” “continue,” “estimates,”
“anticipates,” “expects,” “plans,” “intends,” “may,” “could,”
“might,” “will,” “should,” or other words that convey uncertainty
of future events or outcomes to identify these forward-looking
statements. Such statements are subject to numerous important
factors, risks, and uncertainties that may cause actual events or
results to differ materially from our current expectations,
including, but not limited to, the risks that preliminary, interim
and top-line clinical trial results may not be indicative of, and
may differ from, final clinical data; that unfavorable new clinical
trial data may emerge in ongoing clinical trials or through further
analyses of existing clinical trial data; that earlier non-clinical
and clinical data and testing of may not be predictive of the
results or success of later clinical trials; and that that clinical
trial data are subject to differing interpretations and
assessments, including by regulatory authorities. These and other
risks and uncertainties are more fully described in our annual and
periodic filings with the Securities and Exchange Commission (SEC),
including the risk factors described in the section entitled “Risk
Factors” in the quarterly and annual reports that we file with the
SEC. Any forward-looking statements that we make in this press
release speak only as of the date of this press release. Except as
required by law, we assume no obligation to update forward-looking
statements contained in this press release whether as a result of
new information, future events, or otherwise, after the date of
this press release.
Contact:Tiffany HamiltonHead of
CommunicationsTiffany.Hamilton@ocugen.com
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