Scilex Holding Company (“Scilex”), a Sorrento Company (nearly 100%
or over 99.9% majority-owned subsidiary of Sorrento Therapeutics,
Inc.) (Nasdaq: SRNE, “Sorrento”) and a commercial biopharmaceutical
company focused on developing and commercializing non-opioid
therapies for patients with acute and chronic pain, announced
pivotal Phase 3 SEMDEXATM data presentation at the American Society
of Interventional Pain 2022 annual meeting. The pivotal Phase 3
SP-102 (SEMDEXATM) trial has a highly positive results evaluating
SEMDEXATM in sciatica patients following an epidural injection was
presented at the Innovation summit session of the 2022 American
Society of Interventional Pain (ASIPP) Annual Scientific Meeting in
Las Vegas, Nevada. Results from this multicenter, randomized,
double-blind, placebo-controlled study demonstrated that patients
experienced rapid onset of pain reduction in sciatica pain and the
effect lasted for up to 99 days following a single injection of
SEMDEXATM at the end of the procedure. This is the first time this
trial study data has been presented at a major North American
medical meeting.
The podium presentation described the Phase 3 trial, known as
the C.L.E.A.R. trial program, randomized 401 lumbosacral radicular
pain/sciatica patients at 40 sites across 25 states in the U.S.,
which is the largest double-blind randomized controlled epidural
steroid injection clinical trial in sciatica.
Presenting Author: Prof. Dr. Nebojsa Nick Knezevic,
M.D., Ph.D., Professor of Anesthesiology and Surgery, College of
Medicine, University of Illinois at Chicago, President of the
Illinois Society of Interventional Pain Physicians,
Director-at-Large of the North American Society of Neuromodulation,
Vice-Chair for Research and Education, Advocate Illinois Masonic
Medical Center, Department of Anesthesiology and Pain
Management.
The presentation at the Innovation Summit session, ASIPP on May
5, 2022, described the outcome of the C.L.E.A.R. trial. Key
findings from this study include:
- The study met its primary endpoint
with a highly statistically significant reduction in average daily
leg pain in patients receiving SEMDEXATM compared to placebo
(p<0.001).
- A total of 401 sciatica patients
were enrolled at 40 clinical sites in US.
- The median time (days) to repeat
injection in Placebo group was 57 and 99 days in the SEMDEXATM
group, according to Kaplan-Meier estimation (p<0.001).
- Safety analysis demonstrated a
clean safety profile with no identified safety risks. There were no
serious adverse events related to the drug or injection procedure,
and no adverse events of special interest reported, such as
hematoma and infection at the injection site, or paraplegia. The
C.L.E.A.R trial also established the safety of repeat injections,
as patients who experienced moderate-to-severe radicular pain
between 4 and 23 weeks were allowed to receive open-label
additional SP-102 (SEMDEXA™) injection.
- The key secondary endpoint of
Oswestry Disability Index, the gold standard for measuring degree
of disability and estimating quality of life, showed a 28%
improvement at 4 weeks on SP-102 (SEMDEXA™) compared to baseline
(minimal clinically meaningful improvement 8%-12%).
"These Phase 3 data demonstrate that the median time to repeat
injection for patients treated with SEMDEXATM was significantly
longer than those treated with placebo," said Dmitri Lissin, SVP
and CMO of Scilex Holding. "We believe these data coupled with
Phase 2 results from our repeat-dose trial and earlier PK/PD trial
in sciatica patients will help support product registration with
the FDA and utility of SEMDEXATM in a pain clinic setting. This is
the first time that these pivotal Phase 3 data are being presented
at a North American medical meeting and we believe this is another
important milestone as we execute on our clinical and
pre-commercial strategies."
There is about 60% use of opioid pain medications for chronic
back pain2 which is directly linked to many new persistent opioid
users every year and up to many new cases of Opioid Use Disorder
annually, making low back pain opioid use an important contributor
to the opioid epidemic in the United States.
“With more than 30 million low back pain and sciatica patients
every year in the US3,4, there is enormous need for an approved
treatment and a desperate need for effective non-opioid
alternatives,” said Annu Navani, Secretary ASIPP and Medical
Director, Comprehensive Spine & Sports Center and Adjunct
Clinical Associate Professor, Stanford University School of
Medicine. “Epidural steroid injections have been used more than
half a century for low back and leg pain, and there has always been
a need for safer, longer lasting and more efficacious
formulations.”
Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq:
VCKA) (“VCKA”), a special purpose acquisition company sponsored by
Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan)
Pte Ltd, entered into a definitive business combination agreement
("BCA") on March 17, 2022. Upon the closing of the transaction, the
combined company (the “Combined Company”) will be renamed Scilex
Holding Company, and its common stock is expected to be listed on
Nasdaq under the ticker symbol “SCLX”. The boards of directors of
each of VCKA, Scilex and Sorrento have unanimously approved the
proposed transaction. The closing of the transaction, which is
expected to occur by the third quarter of 2022, is subject to the
approval of VCKA’s shareholders and the satisfaction or waiver of
certain other customary closing conditions.
A corporate presentation describing Scilex's development plans
can be found at www.scilexholding.com.
About Scilex Holding Company
Scilex Holding Company, a Sorrento Company
(nearly 100% or over 99.9% majority-owned subsidiary of Sorrento
Therapeutics, Inc.), is dedicated to the development and
commercialization of non-opioid pain management products for
treatment of acute and chronic pain. Scilex is uncompromising in
its focus to become the global pain management leader committed to
social, environmental, economic, and ethical principles to
responsibly develop pharmaceutical products to maximize quality of
life. Highly positive results from the Phase III Pivotal Trial
C.L.E.A.R Program for SEMDEXATM, its novel, non-opioid product for
the treatment of lumbosacral radicular pain (sciatica), were
announced in March 2022. Scilex targets indications with high unmet
needs and large market opportunities with non-opioid therapies for
the treatment of patients with moderate to severe pain. Scilex
launched its first commercial product in October 2018 and is
developing its late-stage pipeline, which includes a pivotal Phase
3 candidate and one Phase 2 and one Phase 1 candidate. Its
commercial product, ZTlido® (lidocaine topical system) 1.8%, or
ZTlido®, is a prescription lidocaine topical product approved by
the U.S. Food and Drug Administration for the relief of pain
associated with postherpetic neuralgia, which is a form of
post-shingles nerve pain. Scilex’s three product candidates are
SP-102 (injectable dexamethasone sodium phosphate viscous gel
product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3,
novel, viscous gel formulation of a widely used corticosteroid for
epidural injections to treat lumbosacral radicular pain, or
sciatica, with FDA Fast Track status; SP-103 (lidocaine topical
system) 5.4%, a Phase 2, triple-strength formulation of ZTlido®,
for the treatment of low back pain; and SP-104, 4.5 mg Delayed
Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule,
for the treatment of chronic pain, fibromyalgia in multiple Phase 1
programs expected to be initiated this year. For further
information regarding the SP-102 Phase 3 efficacy trial, see NCT
identifier NCT03372161 - Corticosteroid Lumbar Epidural Analgesia
for Radiculopathy - Full Text View - ClinicalTrials.gov.
Scilex Holding Company is headquartered in Palo Alto,
California, with operations in both Palo Alto and San Diego,
California. For further information please visit
www.scilexholding.com.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage
biopharmaceutical company developing new therapies to treat cancer,
pain (non-opioid treatments), autoimmune disease 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”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including Abivertinib, COVISHIELD™ and COVI-MSC™;
and diagnostic test solutions, including COVIMARK™.
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 postherpetic neuralgia (PHN). RTX has
been cleared for a Phase II trial for intractable pain associated
with cancer and a Phase II trial in osteoarthritis patients.
Positive final results from the Phase III Pivotal Trial C.L.E.A.R.
Program for SEMDEXA™, its novel, non-opioid product for the
treatment of lumbosacral radicular pain (sciatica), were announced
in March 2022. ZTlido® was approved by the FDA on February 28,
2018.
For more information visit
www.sorrentotherapeutics.com
About Vickers Vantage Corp. I
Vickers Vantage Corp. I is a blank check company
formed for the purpose of effecting a merger, share exchange, asset
acquisition, share purchase, reorganization or similar business
combination with one or more businesses or entities.
Important Information for Investors and
Stockholders
This press release relates to a proposed transaction between
Scilex and VCKA. This press release does not constitute an offer to
sell or exchange, or the solicitation of an offer to buy or
exchange, any securities, nor shall there be any sale of securities
in any jurisdiction in which such offer, sale or exchange would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. In connection with the
transaction described herein, VCKA intends to file relevant
materials with the SEC, including a registration statement on Form
S-4, which will include a document that serves as a prospectus and
proxy statement of VCKA, referred to as proxy statement/prospectus.
After the registration statement is declared effective by the SEC,
the proxy statement/prospectus will be sent to all VCKA
shareholders as of a record date for the meeting of VCKA
shareholders to be established for voting on the proposed business
combination. VCKA will also file other documents regarding the
proposed transaction with the SEC. This press release does not
contain all of the information that will be contained in the proxy
statement/prospectus or other documents filed or to be filed with
the SEC. Investors and security holders of VCKA are urged
to read these materials (including any amendments or supplements
thereto) and any other relevant documents in connection with the
transaction that VCKA files with the SEC when, and if, they become
available because they will contain important information about
VCKA, Scilex and the proposed transaction. Investors
and security holders will be able to obtain free copies of the
registration statement, the proxy statement/prospectus and all
other relevant documents filed or that will be filed with the SEC
by VCKA through the website maintained by the SEC at
www.sec.gov.
Participants in the Solicitation
VCKA and its directors and executive officers may be deemed
participants in the solicitation of proxies from VCKA’s
shareholders in connection with the transaction. A list of the
names of such directors and executive officers and information
regarding their interests in the proposed business combination will
be contained in the proxy statement/prospectus when available. You
may obtain free copies of these documents as described in the
preceding paragraph.
Scilex and its directors and executive officers
may also be deemed to be participants in the solicitation of
proxies from the shareholders of VCKA in connection with the
proposed transaction. Information about Scilex’s directors and
executive officers and information regarding their interests in the
proposed transaction will be included in the proxy
statement/prospectus for the proposed transaction.
Non-Solicitation
This press release is not a proxy statement or
solicitation of a proxy, consent or authorization with respect to
any securities or in respect of the potential transaction and shall
not constitute an offer to sell or a solicitation of an offer to
buy the securities of VCKA, the Combined Company or Scilex, nor
shall there be any sale of any such securities in any state or
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act of 1933, as amended.
Forward-Looking Statements
This press release and any statements made for
and during any presentation or meeting concerning the matters
discussed in this press release contain forward-looking statements
related to VCKA, Sorrento Therapeutics, Inc. and its subsidiaries,
including but not limited to Scilex, under the safe harbor
provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995 and are subject to risks and uncertainties that
could cause actual results to differ materially from those
projected. Forward-looking statements include statements regarding
the efficacy and safety profile of SP-103 for treatment of LBP in
patients, the ability of SP-103 to address limitations of
prescription lidocaine patches in treating acute LBP, Scilex’s
expected timeline to complete this Phase 2 study and plans for
subsequent phase 3 trial(s),the proposed business combination
between Scilex and VCKA, including the timing of such business
combination, the potential listing of the Combined Company’s common
stock on Nasdaq or other major securities exchange and the
anticipated stock ticker symbol for such shares, the expectation
that VCKA will file a registration statement on Form S-4 with
the SEC, which would include a proxy statement/prospectus, the
estimated or anticipated future results and benefits of the
Combined Company following the proposed business combination,
including the likelihood and ability of the parties to successfully
consummate the proposed business combination, future opportunities
for the Combined Company, the timing of the completion of the
proposed business combination, Scilex’s and the Combined Company’s
proposed business strategies, the expected cash resources of the
Combined Company and the expected uses thereof; Scilex’s and the
Combined Company’s current and prospective product candidates,
planned clinical trials and preclinical activities and potential
product approvals, as well as the potential for market acceptance
of any approved products and the related market opportunity;
statements regarding SP-102 (SEMDEXA™) or SP-103, if approved by
the FDA; Scilex’s development and commercialization plans; and
Sorrento’s products, technologies and prospects and Scilex’s
products, technologies and prospects, including the potential for
Scilex’s product candidates to be best-in-class or first-in-class
therapies. Risks and uncertainties that could cause
Sorrento’s and Scilex’s actual results to differ materially and
adversely from those expressed in our forward-looking statements,
include, but are not limited to: the inability of the parties to
consummate the proposed business combination transaction for any
reason or the occurrence of any event, change or other
circumstances that could give rise to the termination of the BCA,
including any failure to meet applicable closing conditions;
changes in the structure, timing and completion of the proposed
transaction between VCKA and Scilex; VCKA’s ability to continue its
listing on the Nasdaq Capital Market until closing of the proposed
transaction; the Combined Company’s ability to list its securities
on Nasdaq or other major securities exchange after closing of the
proposed transaction; the ability of the parties to achieve the
benefits of the proposed transaction, including future financial
and operating results of the Combined Company; the ability of the
parties to realize the expected synergies from the proposed
transaction; risks related to the outcome of any legal proceedings
that may be instituted against the parties following the
announcement of the proposed business combination; general
economic, political and business conditions; risks related to the
ongoing COVID-19 pandemic; the risk that the potential product
candidates that Scilex develops may not progress through clinical
development or receive required regulatory approvals within
expected timelines or at all; risks relating to uncertainty
regarding the regulatory pathway for Scilex’s product candidates;
the risk that Scilex will be unable to successfully market or gain
market acceptance of its product candidates; the risk that Scilex’s
product candidates may not be beneficial to patients or
successfully commercialized; the risk that Scilex has overestimated
the size of the target patient population, their willingness to try
new therapies and the willingness of physicians to prescribe these
therapies; risks that the results of the Phase 2 trial for SP-103
may not be successful; risks that the prior results of the clinical
trials of SP-102 (SEMDEXA™) or SP-103 may not be replicated;
regulatory and intellectual property risks; the risk that any
requisite regulatory approvals to complete the transaction are not
obtained, are delayed or are subject to unanticipated conditions
that could adversely affect the Combined Company or the expected
benefits of the proposed transaction or that the approval of VCKA’s
shareholders is not obtained; the risk of failure to realize the
anticipated benefits of the proposed transaction; the amount of
redemption requests made by VCKA’s shareholders and other risks and
uncertainties indicated from time to time and other risks set forth
in Sorrento’s and VCKA’s filings with the SEC. 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 may be required by law.
Contacts:
For Scilex Holding Company
Jaisim ShahChief Executive OfficerScilex Holding Company 960 San
Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310Email:
jshah@scilexpharma.com
Website: www.sorrentotherapeutics.com and
www.scilexholding.com
Investors and Media Contact:
Contact: Brian CooleySenior Vice PresidentCorporate
Communications and Investor RelationshipsHead of Lymphatic Drug
DeliveryEmail: mediarelations@sorrentotherapeutics.comWebsite:
www.sorrentotherapeutics.comFor Vickers Vantage Corp. I
Jeffrey Chi Chief Executive Officer 85 Broad Street, 16th
FloorNew York, NY 10004Phone: (646) 974-8301Email:
jeff.chi@vickersventure.com
Website: www.vickersvantage.com
Investors and Media Contact: Nicolette Ten, Senior Account
Executive, SPRGEmail: nicolette.ten@sprg.com.sg
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™,
COVISHIELD™, COVI-MSC™, and COVIMARK™ are trademarks of Sorrento
Therapeutics, Inc.
SEMDEXA™ (SP-102) is a trademark owned by Semnur
Pharmaceuticals, Inc., a wholly owned subsidiary of Scilex Holding
Company. A proprietary name review by the FDA is planned.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc., a wholly owned subsidiary of Scilex
Holding Company.
All other trademarks are the property of their
respective owners.
© 2022 Sorrento Therapeutics, Inc. All Rights
Reserved.
References |
1) |
Yoshina et
al., 2019 and Ostelo, de Vet. Clinically important outcomes in low
back pain. Best Practice & Research Clinical Rheumatology.
Volume 19, Issue 4, August 2005, Pages 593-607. |
2) |
Deyo & Weinstein 2001 |
3) |
Decisions Resources Group. Chronic Pain: Disease Landscape and
Forecast. 2016; 76 & 80 |
4) |
Decisions Resources Group. Chronic Pain: Disease Landscape and
Forecast. 2016; 40 |
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