Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced
that an interim analysis of an ongoing Phase 1b study of
resiniferatoxin (RTX) administered via epidural route in patients
with intractable cancer pain has generated positive data. The study
is completing enrollment of an additional 25 ug expansion dose
cohort. Based on full study results a dose will be selected for RTX
to proceed to Phase 3 pivotal trials in patients with advanced
cancer pain.
Safety in the higher dose cohort is expected to be supportive
for testing RTX epidural administration in other advanced
non-cancer disease related unmet clinical needs (with a choice of
starting dose at 15 or 25 ug depending on the indication
considered).
Results as planned in the original study (to 15 ug) are being
presented at the American Academy of Pain Medicine Annual Meeting
on February 27, 2020.
The Phase 1b open-label study was used for dose
escalation to assess the safety and preliminary efficacy of a
single epidural administration of resiniferatoxin for the treatment
of intractable pain due to cancer. Initial expectations for safety
and efficacy have been met for the Phase 1b study, though optimal
dose selection will follow assessment of the additional dose group
in which 25 ug is also being evaluated. Thus far, after
Institutional Review Board approval was obtained, and with
oversight by an independent data monitoring committee, data is
available from 14 subjects with intractable cancer-related pain who
received a single epidural injection of RTX from 0.4 to 15 ug.
Safety Outcomes
No dose limiting toxicities or notable adverse
events unrelated to progression of underlying disease were
encountered for any of the subjects. The most common
treatment-related adverse event was transient post-procedural pain:
7 of 14 subjects (50%) reported moderate severity. Two additional
treatment-related adverse events of moderate severity were back
pain and increase in blood pressure in a patient. All events
resolved in less than two days following drug administration.
Efficacy Outcomes
The ongoing trial will follow subjects for at least 84 days. The
lower doses of 0.4, 1.0, 2.0, 4.0 ug did not demonstrate notable
pain relief, but permitted dose escalation to the next designated
dose level based on how well the drug was tolerated.
Three patients had marked pain relief starting
shortly after initial administration that were still observed weeks
after treatment: 1 of 3 subjects who received 8 ug (a 58-year-old
woman with gastrointestinal stromal cancer with severe lower back
pain reported a decrease in numerical pain rating scale (NPRS)
scores from >6/10 to 2/10), and 2 of 3 subjects who received 15
ug (a 62-year-old man with rectal cancer noted significant
improvement in pain, physical strength, mood, and appetite with
NPRS scores reduced from 7-8/10 to 3/10; and a 57-year-old man with
multiple myeloma and severe pain in his back, hips, and lower
extremities subsequently reported mild pain in the target areas
after RTX injection). Improvement in pain and mobility within 24
hours of dosing in the three responders at the higher dose levels
of RTX suggests the clinical potential of the drug for intractable
cancer pain.
Sorrento intends to present the detailed results
of the completed study upon completion of the additional expansion
cohort later this year. A pivotal Phase 3 trial is being planned
using epidural RTX for severe pain states associated with advanced
disease.
“We are encouraged by the benefits of using RTX to treat
intractable pain in patients with metastatic cancer,” said
Associate Professor of Anesthesia, Srdjan S. Nedeljkovic, M.D. from
the Department of Anesthesiology, Perioperative and Pain Medicine,
Brigham and Women’s Hospital at Harvard Medical School. “Even in
patients with high levels of pain, RTX given via an epidural
injection has been found to reduce pain intensity without having
any long-term adverse safety consequences. The addition of RTX to
existing cancer pain therapies represents a positive step forward
in improving the care of patients with intractable cancer pain and
offers the hope of enhancing the overall quality of life
experienced by this population.”
For access to the scientific presentation (AAPM poster) please
visithttp://investors.sorrentotherapeutics.com/events-and-presentations/presentations
About Resiniferatoxin (RTX)
A thousand times “hotter” than pure capsaicin (16 Billion
Scoville units versus 16M), and with a high affinity for afferent
pain nerves, resiniferatoxin binds to TRPV1 receptors and
selectively ablates the nerve endings responsible for pain signals
experienced by patients1. Delivered peripherally (into the joint
space) the transient nerve ending ablation effect can have profound
clinical benefits lasting for months to years (as shown in canine
studies2).
RTX-001 is a multicenter, open-label dose escalation Phase 1b
study to assess the safety and define the maximally tolerated dose
of resiniferatoxin administered via the epidural route for the
reduction of moderate to severe pain signal intensity associated
with advanced cancer. The Phase 1b study is a dose-escalation
protocol in which cohorts of patients receive increasing doses of
resiniferatoxin until the maximum tolerated dose is achieved. The
primary objective of the study is to evaluate the safety of
resiniferatoxin and identify the recommended Phase 3 dose. The
secondary objective is to assess the preliminary efficacy of
resiniferatoxin measured by assessing changes in the intensity of
pain using the NPRS score, a widely used proprietary validated pain
scale.
RTX is not approved for clinical use by regulatory authorities.
Safety and efficacy have not been established.
More information on this trial can be found at
www.clinicaltrials.gov (NCT03226574).
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to turn
malignant cancers into manageable and possibly curable diseases.
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”), intracellular
targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”),
and clinical stage oncolytic virus (“Seprehvir®”).
Sorrento's commitment to life-enhancing therapies for patients
is also demonstrated by its effort to advance a first-in-class
(TRPV1 agonist) non-opioid pain management small molecule,
resiniferatoxin (“RTX”), and ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. Resiniferatoxin
is completing a Phase 1b trial for intractable pain associated with
cancer and a Phase 1b trial in osteoarthritis patients. 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 expectations for Sorrento's and its subsidiaries'
technologies and product candidates, including, but, not limited
to, resiniferatoxin (RTX), the clinical potential of RTX, timing
for completion and providing detailed results from the Phase 1b
study and the potential timing and dose selection for any Phase 3
trial for RTX for the treatment of intractable pain associated with
cancer. 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' technologies and
prospects, including, but not limited to, RTX; risks related to
seeking regulatory approvals and conducting and obtaining results
of clinical trials, including, but not limited to, the Phase 1b
study and any prior RTX studies in animals; costs associated with
clinical trials, the clinical and commercial success of RTX; the
viability and success of using RTX for treatments in certain
therapeutic areas, including for the treatment of intractable pain
associated with cancer 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, 2018, 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 RelationsContact: Alexis
Nahama, SVP Head of RTX Program.Telephone: 1.858.203.4120Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.ZTlido® and G-MAB™ are trademarks owned
by Scilex Pharmaceuticals Inc. and Sorrento,
respectively.Seprehvir®, is a registered trademark of
Virttu Biologics Limited, a wholly-owned subsidiary of TNK
Therapeutics, Inc. and part of the group of companies owned by
Sorrento Therapeutics, Inc. All other trademarks are the property
of their respective owners. © 2020 Sorrento Therapeutics, Inc. All
Rights Reserved.
_____________________________________
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC398431/2 Sorrento
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