Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today
announced receipt of clearance from the Brazilian regulatory agency
(ANVISA) to proceed with a Phase 2 Pivotal clinical trial of
COVI-MSC™, an injectable infusion of mesenchymal stem cells, for
the treatment of hospitalized COVID-19 patients suffering from
ARDS.
The Brazil study is a Phase 2 Pivotal,
multi-center, randomized, controlled study to evaluate the safety
and efficacy of three infusions of COVI-MSC™, administered every
other day, to hospitalized patients experiencing moderate or severe
COVID-19 with ARDS. The study is expected to enroll 100 patients
(33 placebo and 67 treated patients) in three months from the date
of first enrollment. Sorrento expects this projected pace of
enrollment due to the extensive COVID-19 disease burden in Brazil,
Sorrento’s partnership with a leading local clinical research
organization (Synova Health), and existing relationships with high
quality medical centers throughout the country. The current
partnership with Synova Health leverages high quality clinical
trial sites in addition to a dozen centers already enrolling
COVID-19 patients for another Sorrento Phase 2 clinical trial
(Abivertinib). Additional studies are also being discussed for
early clearance in parallel or immediately following this study.
Priority access to multiple trials is being given to Brazilian
patients following the rapid and openly collaborative interactions
Sorrento has been able to establish with ANVISA regulators.
“We are very satisfied with the progress made in
Brazil so far, and we have developed strong local relationships in
support of multiple studies,” stated Dr. Henry Ji, Chairman and CEO
of Sorrento. “By focusing on the geographies most impacted by
COVID-19, we are able to implement synergistic programs to answer
safety and efficacy questions related to our product candidates
while helping patients where the disease has been spreading the
most. We expect this next Phase 2 Pivotal study to confirm the
clinical benefits initially observed in our recently completed open
label Phase 1b study. If confirmed, we are ready to establish a
plan for development and manufacturing commitments that are
required by ANVISA to take the product candidate from clinical
trials to emergency use authorization (EUA) approval, including
generating the data needed to support making the drug accessible
prior to any full registration.”
The study is referenced with ANVISA (Brazilian
authority) under Process nº 25351.986743/2021-44,
COMUNICADO ESPECIAL (CE) Nº 0004/21 –
GSTCO/DIRE1/Anvisa.
Details of the Brazilian Clinical Study can be
found at:Study of Intravenous Administration of Allogeneic
Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute
Respiratory Distress - Full Text View - ClinicalTrials.gov
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®", “Seprehvec™”). 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 1B 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 StatementsThis
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 initiation of a Phase 2
study for COVI-MSC; the expected number of patients to be enrolled
in the Phase 2 study; the expected timing for commencing and
completing enrollment of the Phase 2 study; Sorrento’s expectation
to utilize its partnership with Synova Health and other existing
relationships with medical centers throughout Brazil to facilitate
enrollment of the Phase 2 study; Sorrento’s ability to use centers
enrolling COVID-19 patients for Sorrento’s Phase 2 clinical trial
of Abivertinib for enrollment of patients in the Phase 2 clinical
trial for COVI-MSC; the potential for the Phase 2 study to be
considered for expansion as a global trial; the potential for
Sorrento to recruit patients for the Phase 2 study in the U.S. and
Brazil; the potential for additional studies to receive clearance
in parallel or immediately following the Phase 2 study; Sorrento’s
ability to implement synergistic programs that answer safety and
efficacy questions related to product candidates; Sorrento’s
expectation that the Phase 2 study will confirm clinical benefits
initially observed in Sorrento’s open label Phase 1b study of
COVI-MSC; the potential therapeutic benefits of COVI-MSC;
Sorrento’s ability to establish a plan for development and
manufacturing commitments needed for emergency use approval if
clinical benefits of COVI-MSC are confirmed; the potential for
pre-clinical and clinical data and results to be replicated in
future clinical trials; regulatory approvals of COVI-MSC; and the
completion of clinical trials of COVI-MSC. 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
COVI-MSC; 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 product
candidates 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.
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™,
COVIGUARDTM, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™,
COVI-MSC™, COVITRACK™, COVI-TRACE™ and COVISTIX™ 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.
Sorrento Therapeutics (NASDAQ:SRNE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sorrento Therapeutics (NASDAQ:SRNE)
Historical Stock Chart
From Apr 2023 to Apr 2024