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 today
that safety data from Scilex’s Phase 1 clinical trial demonstrated
that SP-104 was better tolerated than immediate release naltrexone
hydrochloride 4.5 mg at the same dose in healthy volunteers. A
second Phase 1 pharmacokinetic trial has completed enrollment and
results will be available soon.
SP-104 is a novel, proprietary, fixed dose, delayed burst
release of low dose naltrexone, for the treatment of FM and has an
end goal of reducing side effects associated with formulations of
immediate release naltrexone and FM disease burden. SP-104 has key
clinical data supporting its use in the treatment of FM. Prior
investigational trials support the use and development of SP-104,
delayed burst release naltrexone hydrochloride 4.5 mg, for FM.
Currently there are no low-dose formulations (i.e., less than 5 mg)
available. Physicians currently use the commercially available
high-dose tablets (naltrexone hydrochloride 50 mg) and have
compounding pharmacies aliquot lower doses for patients.
Pharmacy-compounding is inherently inaccurate and does not involve
analyses to confirm that the aliquoted product has the target level
of drug, and there is no assurance as to content uniformity within
a batch as well as other quality attributes critical for
pharmaceutical product performance. This can lead to errors in
dosing and challenges with titration. The commercial products and
pharmacy-compounded products also allow for the immediate release
of the drug in the stomach, which can lead to compliance challenges
due to severe side effects. Common side effects for naltrexone
include hyperalgesia, dysphoria, insomnia and anxiety. All these
issues culminate into patient compliance issues and result in the
eventual abandonment of an otherwise viable therapy to treat this
debilitating disease. SP-104 uses delayed burst release technology
that bypasses the stomach and releases the drug in the gut (upper
intestine). When taking SP-104 at night before bed, peak drug
levels are achieved at night during sleep, allowing the patient to
avoid conscious perception of hyperalgesia and other side effects.
The combination of the delayed-release and administration at night
may also maximize efficacy as most endorphin/enkephalin release is
during sleep, which maximizes the product’s potential to elicit
compensatory response.
Scilex is committed to develop SP-104 for FM. Phase 1 studies
are to characterize the pharmacokinetic and safety profile of
SP-104, and Scilex intends to initiate a Phase 2 study in the
second half of 2022. If successful, we believe SP-104 can become a
pivotal treatment for management of FM, which represents a large
commercial opportunity with high unmet needs. “There is a clear
medical need for new, safe and effective treatments with the
potential to improve care for the estimated 10 million FM patients
in the U.S. and more than 200 million worldwide,” commented Dmitri
Lissin, M.D., Chief Medical Officer of Scilex. “Our Phase 1
clinical trial data demonstrated that healthy volunteers treated
with SP-104 had lower rates of adverse events, as compared with
immediate release naltrexone -treated volunteers. This is an
especially encouraging result when viewed in the background of the
large number of current FM patients and high provider
dissatisfaction with the few existing approved FM treatments”.
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 SEMDEXA™, 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, COVI-AMG™, COVISHIELD™,
COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including
COVITRACK™ and 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-104 for treatment of FM in
patients, the ability of SP-104 to address limitations of currently
used commercially available high-dose tablets in treating FM,
Scilex’s expected timeline to complete this Phase 1 study, plans
for a second Phase 1 pharmacokinetic trial and plans for subsequent
phase 2 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™), SP-103 or SP-104, 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
or Phase 1 trial for SP-104 may not be successful; risks that the
prior results of the clinical trials of SP-102 (SEMDEXA™),SP-103 or
SP-104 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.
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