Orbsen's stromal cell immunotherapy, ORBCEL, may benefit
patients with Acute Respiratory Distress Syndrome
(ARDS) caused by coronavirus (COVID-19)
GALWAY, Ireland, April 8, 2020 /PRNewswire/ -- Orbsen
Therapeutics, a biotechnology company focused on the development
and commercialization of best-in-class stromal cell
immunotherapies, announced the beginning of a phase 2a clinical
trial for the treatment of COVID-19 patients with acute respiratory
distress syndrome (ARDS). Nearly 90 percent of deaths caused by
COVID-19 are the result of ARDS.
Orbsen's ORBCEL recently completed a successful phase 1 trial in
patients with moderate to severe ARDS. In pre-clinical studies,
ORBCEL, a next-generation stromal cell immunotherapy, demonstrated
the ability to mitigate the devastating effects of ARDS by
improving lung oxygenation, lessening inflammation, reducing edema
and decreasing bacterial infection.
"The successful completion of ORBCEL's phase 1 clinical trial,
intended to assess ORBCEL safety in patients, confirms our belief
in the potential of Orbsen's proprietary stromal cell immunotherapy
technologies," said Dr. Larry
Couture, CEO of Orbsen Therapeutics. "We believe ORBCEL will
prove a valuable addition to the arsenal of therapies to combat the
effects of COVID-19."
The phase 2a clinical trial, funded by the Wellcome Trust, has
been approved by the United
Kingdom's Medical Health Regulatory Agency (MHRA). Also, the
UK's National Institute of Health Research (NIHR) designated the
trial as a National Urgent Public Health Study.
"While more than 100 vaccines and therapies targeting COVID-19
are in development, there are no disease modifying therapies
approved for ARDS," said Dr. Steve
Elliman, Chief Scientific Officer at Orbsen. "We take
seriously NIHR's designation of this trial as an Urgent Public
Health Research Study and believe ORBCEL has the potential to be a
timely and effective treatment for patients with ARDS."
Patients have already begun enrolling in the study. Five
clinical trial sites throughout the UK will host the study led by
clinical investigators from Queen's University Belfast. Other trial
supporters include the Health and Social Care Research &
Development Division and the Belfast Health and Social Care
Trust.
ORBCEL is derived from a select and highly purified population
of immunomodulatory stromal cells obtained from umbilical cord
tissue. Orbsen currently is enrolling and treating patients in
additional clinical trials across Europe to assess ORBCEL's safety and efficacy
in the prevention and treatment of diabetic kidney disease,
auto-immune hepatitis and primary sclerosing cholangitis. Another
trial is pending regulatory review in the UK for patients with
several auto-immune disorders.
About Orbsen Therapeutics
Orbsen Therapeutics, Ltd. is a leading company in the
development of cellular immunotherapies across four immune-mediated
inflammatory conditions. Founded in 2006, Orbsen Therapeutics Ltd.,
is a privately held company led by global leaders in the field of
cellular immunotherapy. The company, which spun-out from
Ireland's Regenerative Medicine
Institute at the National University of
Ireland Galway, has developed proprietary technologies that
enables the isolation of a well characterized population of pure
stromal cells from human tissues which, once isolated, can be
expanded and frozen to generate multiple doses of an "off the
shelf" therapeutic product.
Media Contact:
Rand
Walton
804-647-4526
rwalton@waltonstrategic.com