Sorrento Announces Positive Results of Phase 1b Study of COVI-MSC™ Treatment of ICU Covid-19 Patients, Achieving 100% (10 o...
April 20 2021 - 9:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced
today the completion of enrollment in its Phase 1b study of human
allogeneic adipose-derived mesenchymal stem cells (COVI-MSC™)
infusions to treat COVID-19 induced acute respiratory failure (ARD)
or acute respiratory distress syndrome (ARDS). This current study
(MSC-COV-101) is a single arm, non-randomized Phase 1b study of the
safety and preliminary efficacy of COVI-MSCs administered every
other day for up to three infusions for a total of 1 x 106
cells/kg, with patients being followed for 28 days following the
final infusion.
A total of 10 patients (8 males/2 females; age
range 24-65 years; 8 Caucasian/2 Asian; 7 Hispanic/Latino/3
non-Hispanic/Latino; height 64 to 70 inches; weight 66 to 130 kg)
were enrolled and all were discharged from the hospital to home
within three days of their last infusion. At baseline, all patients
required oxygen supplementation and had PaO2/FiO2 ratios ranging
from 135 to 256 (normal ˃ 400). All patients had various medical
co-morbidities in addition to obesity. The 10th patient had been
under treatment for nearly 2 weeks without improvement and was
discharged after the 2nd COVI-MSC infusion with oxygen saturations
in the high 90s on room air. On follow up days later, the patient
was still doing well.
The study met its primary objective: to
demonstrate the safety of intravenous infusion of allogeneic
adipose MSC cells in patients with COVID-19-induced ARD or ARDS.
Dr. Eyad Almasri, Associate Professor of Medicine, Pulmonary,
Critical Care and Sleep Medicine at UCSF Fresno, is the principal
investigator of this study.
Sorrento will be working with the FDA in the
near future once the full dataset is available to plan a
placebo-controlled pivotal study to support an emergency use
authorization (EUA) submission. The study is expected to be
conducted across multiple sites in the United States and
Brazil.
Dr. Henry Ji, President and CEO of Sorrento
Therapeutics, stated, “We look forward to moving our stem cell
program forward in development and working with FDA and ANVISA to
bring this product to patients in need.”
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat cancers
and COVID-19. Sorrento's multimodal, multipronged approach to
fighting cancer is made possible by its extensive immuno-oncology
platforms, including key assets such as fully human antibodies
(“G-MAB™ library”), clinical stage immuno-cellular therapies
(“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and
clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™,
Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions,
including COVITRACK™, COVISTIX™ and COVITRACE™.
Sorrento's commitment to life-enhancing
therapies for patients is also demonstrated by our effort to
advance a first-in-class (TRPV1 agonist) non-opioid pain management
small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg,
dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel,
viscous gel formulation of a widely used corticosteroid for
epidural injections to treat lumbosacral radicular pain, or
sciatica, and to commercialize ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. RTX has
completed a Phase IB trial for intractable pain associated with
cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is
in a pivotal Phase 3 trial for the treatment of lumbosacral
radicular pain, or sciatica. ZTlido® was approved by the FDA on
February 28, 2018.
For more information visit
www.sorrentotherapeutics.com.
Forward-Looking Statements
This press release and any statements made for
and during any presentation or meeting contain forward-looking
statements related to Sorrento Therapeutics, Inc., under the safe
harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995 and subject to risks and
uncertainties that could cause actual results to differ materially
from those projected. Forward-looking statements include statements
regarding the safety and potential efficacy of an adipose-derived
allogeneic MSC product candidate in patients with COVID-19 and in
respiratory distress; the clinical testing of an adipose-derived
allogeneic MSC product candidate; the preliminary results of the
Phase 1b trial to date; the continued enrollment and potential
commencement of future clinical trials for an adipose-derived
allogeneic MSC product candidate; the plans to conduct a
placebo-controlled study to support an emergency use authorization
(EUA) submission; the plans to conduct studies across multiple
sites in the US and Brazil; the potential for preliminary data
results to be replicated or continue to show improved clinical
safety or efficacy as the ongoing trial continues; and our
potential position in the antiviral industry. Risks and
uncertainties that could cause our actual results to differ
materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: risks
related to Sorrento's technologies and prospects, including, but
not limited to risks related to seeking regulatory approval for any
adipose-derived allogeneic MSC product candidate; clinical
development risks, including risks in the progress, timing, cost,
and results of clinical trials and product development programs;
risk of difficulties or delays in obtaining regulatory approvals;
risks that clinical study results may not meet any or all endpoints
of a clinical study and that any data generated from such studies
may not support a regulatory submission or approval; risks that
prior test, study and trial results may not be replicated in future
studies and trials; risks of manufacturing and supplying drug
product; risks related to leveraging the expertise of its
employees, subsidiaries, affiliates and partners to assist Sorrento
in the execution of its therapeutic antibody product candidate
strategies; risks related to the global impact of COVID-19; and
other risks that are described in Sorrento's most recent periodic
reports filed with the Securities and Exchange Commission,
including Sorrento's Annual Report on Form 10-K for the year ended
December 31, 2020, and subsequent Quarterly Reports on Form 10-Q
filed with the Securities and Exchange Commission, including the
risk factors set forth in those filings. Investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release and we undertake no
obligation to update any forward-looking statement in this press
release except as required by law.
Media and Investor Relations
ContactAlexis Nahama, DVM (SVP Corporate
Development)Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™,
COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics,
Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2021 Sorrento Therapeutics, Inc. All Rights
Reserved.
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