Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced
the public release of the results of its’ multicenter, open-label,
Phase 1b Study to Evaluate Safety and MTD of Epidural
Resiniferatoxin Injection for the Treatment of Intractable Cancer
Pain, at the 14th Annual Pain Therapeutics Summit held virtually
from September 21 to 22, 2020. Data was presented by Srdjan
Nedeljkovic, MD, Associate Professor of Anesthesia, Harvard
Medical School/Brigham & Women's Hospital.
“We are extremely encouraged by the results of
this initial study. 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,” 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. “The patient population had intractable
pain that did not respond to other standard therapeutic approaches,
including opioids. The addition of RTX to the management of
patients with intractable advanced-stage cancer pain offers the
prospect of reducing suffering and improving quality of life for
this underserved patient population”.
This multicenter, open-label study enrolled 17
adults with intractable moderate to severe cancer pain. Subjects
were treated with a one-time epidural administration of RTX at
escalating dose level cohorts, ranging from 0.4 µg to 25 µg in 3 ml
saline, in seven cohorts. The first participant in each cohort
served as the “Sentinel” subject. The first two dosing cohorts (0.4
µg and 1.0 µg) each included one subject. Subsequent cohorts
proceeded with three subjects each (2, 4, 8, 15 and 25 µg).
Enrollment of dose escalation cohorts has
completed, with 17 subjects receiving RTX. 65% were women and 35%
were men. The median age was 58 years (range 28-82 years). The
baseline numerical pain rating scale (NPRS) average score was a
mean of 6.8 (standard deviation (S.D.) of 1.65), and the baseline
NPRS worst score was a mean of 7.9 (S.D. of 1.26).
No dose-limiting toxicities were reported. Dose
escalation was completed at 25 ug. The most frequently reported
treatment-emergent adverse event was transient post-procedural pain
that was described in 47.1% of subjects. Post-injection-associated
pain was managed with traditional short-term pain medications on
the day of RTX injection. Typically, the RTX-associated pain
following injection subsided before the 8-hour post-injection
assessment and resolved within 24 hours in all subjects. Transient
and reversible adverse events reported in at least two RTX-treated
subjects were nausea (17.6%), vomiting (17.6%), and headache
(17.6%). A total of 15 serious adverse events (SAEs) were reported,
but none were deemed by the investigator to be related to RTX
treatment. Most adverse events were attributed to the underlying
cancer diagnosis.
Clinical efficacy (CE) was assessed at three
efficacy levels: CE30, CE50 and CE70, defined as a 30%, 50% and 70%
decrease in pain, respectively, for three consecutive days from the
original baseline NPRS score of ≥ 6/10.
A positive outcome was observed in the lowest dose
of RTX administered (0.4 ug) at the CE30 efficacy point. A
dose-response relationship was observed, with the majority of
responders at the 15 ug and 25 ug dose levels. Of the 17 subjects,
11 achieved the CE30 prespecified efficacy end-point using NPRS
scores. Day 90 results for all RTX doses pooled are shown
below:
Percentage decrease in Pain |
Average Pain |
Worst Pain |
> 30% reduction from Baseline |
64.7 |
% |
47.1 |
% |
> 50% reduction from Baseline |
35.3 |
% |
29.4 |
% |
> 70% reduction from Baseline |
23.5 |
% |
17.6 |
% |
PK data revealed no detectable drug in plasma in
15 of the 17 subjects. Minimally detectable levels of RTX were seen
in 2 of the 17 subjects, in each case only at the initial
post-injection time point.
RTX administration was well-tolerated when given
as a one-time epidural injection at doses up to 25 ug. Preliminary
clinical pain improvement was observed in the dose-escalation
phase. Based on the results, though the protocol allowed
exploration of a 35 mcg dose for this indication, a dose
beyond 25 mcg was not deemed necessary to qualify the safety and
clinically meaningful efficacy of the drug. These preliminary data
support further study of epidural RTX in a broader patient
population with what would be considered moderate to severe pain
associated with cancer in this orphan indication.
For access to the poster associated with the
scientific presentation, please visit Sorrento Investor Relations
Site
Sorrento intends to rapidly advance to larger
scale trials and expects to submit a request to proceed with a
multicenter, blinded, controlled Phase 3 trial to the FDA in the
upcoming weeks.
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 was 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
was a dose-escalation protocol in which cohorts of patients
received increasing doses of resiniferatoxin until the maximum
tolerated dose was achieved. The primary objective of the study was
to evaluate the safety of resiniferatoxin and identify the
recommended Phase 3 dose. The secondary objective was 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 treat
cancers. 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 COVIDTRAP™, ACE-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™; and diagnostic test
solutions, including COVI-TRACK™ 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 ZTlido® (lidocaine topical
system) 1.8% for the treatment of post-herpetic neuralgia. RTX 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 commencing larger scale trials for RTX, timing for completion
and submission of a request to proceed with any Phase 3 trial for
RTX and the possibility of proceeding to a Phase 3 trial. 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, including, but not limited
to, RTX; risks related to seeking regulatory approvals and
conducting and obtaining results of clinical trials; costs
associated with clinical trials; risks that prior test, study and
trial results may not be replicated in future studies and 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; 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, 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 Relations
Contact: Alexis Nahama, SVP Head of RTX
Program.
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc. G-MAB™, COVI-GUARD™,
COVI-SHIELD™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MAB™,
COVI-TRACK™, and COVI-TRACE™ are trademarks of Sorrento
Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex
Pharmaceuticals 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
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