Sorrento Therapeutics, Inc. (Nasdaq: SRNE,
"Sorrento") announced today additional
positive results from its Phase 1b study
of human allogeneic adipose-derived mesenchymal
stem cells (COVI-MSC™) for patients suffering
from COVID-19-induced acute respiratory distress
(ARD) or acute respiratory distress syndrome (ARDS).
This ongoing study (PSC-CP-004) is a single arm,
non-randomized Phase 1b study of the safety and preliminary
efficacy of COVI-MSCs administered every other day for
three infusions for a total of 1 x 106 cells/kg. The
primary objective is to evaluate the safety of
intravenous infusion of allogeneic adipose MSC cells in
patients with COVID-19-induced ARD or ARDS.
On January 26, 2021, Sorrento announced the first three
enrolled ICU COVID-19 patients were discharged from
the hospital within a week of starting COVI-MSC
infusions and a fourth patient just started the COVI-MSC treatment
last Monday, January 25, 2021. The fourth patient who had been in
the hospital for more than 2 weeks and required intubation and
mechanical ventilation with worsening pulmonary compromise received
3 infusions of COVI-MSC and improved so rapidly that he was able to
be discharged the evening after his 3rd infusion on January 29,
2021. No infusion related safety events were reported.
Dr. Eyad Almasri, Associate Professor of Medicine, Pulmonary,
Critical Care and Sleep Medicine at UCSF Fresno, is the principal
investigator in this ongoing study.
Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated
“It brings us great joy each time one of our treatments helps to
save a life, after all that is what we at Sorrento work toward each
and every day to save one life at a time.”
More information on the Phase 1 trial can be found
at www.clinicaltrials.gov (NCT04486001). Information
on the proposed Phase 2 trial is expected
to be available soon.
Stem cells have been demonstrated to support resolution of
symptoms in multiple disease settings and have the potential to
reduce the long-term effects associated with pulmonary tissue
damage. More information on the potential use and benefits of
MSCs for patients with COVID-19 can be found in the recently
published review
at: https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02380-2
Personalized Stem Cells, Inc. (PSC) is the GMP
manufacturer partner for Sorrento’s COVI-MSC.
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 COVI-GUARD™, COVI-AMG™, COVI-SHIELD™,
Gene-MAb™, COVI-MSC™ and COVI-DROPS™; and diagnostic test
solutions, including COVI-TRACK™, COVI-STIX™ and
COVI-TRACE™.
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 any future clinical trials for an adipose-derived
allogeneic MSC product candidate, including any Phase 2 trial; 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 and its subsidiaries', affiliates’ and
partners’ technologies and prospects and collaborations with
partners, 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 COVID-19 therapeutic
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, 2019, 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
Contact: Alexis Nahama, DVM (SVP Corporate Development)
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, COVI-GUARD™, COVI-AMG™,
COVI-SHIELD™, Gene-MAb™, COVI-DROPS™, COVI-MSC™, COVI-TRACK™,
COVI-TRACE™ and COVI-STIX™ are trademarks of Sorrento Therapeutics,
Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a 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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