SAN DIEGO, Jan. 22, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") announced that
the phase 1b study of its non-opioid, afferent nerve ablating drug candidate (resiniferatoxin or “RTX”) for the treatment of pain
from osteoarthritis in the knee (intra-articular route of administration) interim data analysis of over 30 patients had positive
activity, prompting Sorrento to start planning pivotal studies to start in 2019.
- Rapid onset of pain relief (day following injection) and sustained clinical benefits (84 days) at the lowest dose
tested.
- Pain at walking (10 points WOMAC scale) reduced by 4.7 points versus control at day 84.
- No dose limiting toxicities, nor adverse events of interest noted for any dose group.
The “Phase 1b double-blind study to assess the safety and preliminary efficacy of intra-articular administration of
resiniferatoxin versus placebo for the treatment of pain due to moderate to severe osteoarthritis of the knee” was expected to
recruit about 40 patients in 5 dose level cohorts or until a maximum tolerated dose (MTD) was reached. In each cohort six patients
received intra-articular RTX and two received a saline control (placebo arm).
No dose limiting toxicities have been observed to date at any dose group (see table 1) and a majority of the patients treated
with the active drug are reporting positive clinical benefits in pain reduction.
The lowest dose cohort treated with a single injection into the knee joint (with 5 mcg RTX) was unblinded after twelve weeks of
observation as authorized per protocol. The RTX treated patients had a mean pain score 4.7 points lower than controls (on the
10 point WOMAC pain scale) at Day 84 (see figure 1). Onset of pain reduction was as early as the day following drug administration
and sustained over time. Patients in higher dose groups are also displaying rapid and sustainable improvements (data still
blinded). As specified in the current protocol, patients will be monitored for 12 months after injection. A clinically effective
dose will be determined by the end of the current study.
“Given these initial results and the feedback from our investigators, we have started the process of planning our pivotal
studies so they can be initiated later this year (2019),” stated Dr. Henry Ji, Chairman and CEO for Sorrento. “We believe this drug
has the potential to rival the best selling non-opiod pain drugs on the market, and make Sorrento an industry leader in non-opioid
pain management. We look forward to discussing our phase 1b data with the FDA and plan the final phase of our RTX knee
osteoarthritis pain development program.”
Table 1: Safety Report as of January 2019 is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/212b8439-71a0-4a5a-a94a-b21b80a337db
* DLT = dose limiting toxicity. AE = adverse event.
Figure 1: WOMAC Question A1 Pain Score Averages (Treated versus Saline Control) – Cohort 1 (5
?g) is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/635b5966-d22e-4f0d-a88d-ca47bf61a560
About Resiniferatoxin (RTX) and the PTVA-OA-001 Study
Joint pain affects over 30 million patients in major markets, half of which suffer from knee osteoarthritis
pain1.
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 patients2. 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 studies3).
PTVA-OA-001 is a multicenter, placebo-controlled phase 1b study (being expanded into a phase 2 study) to assess the safety and
define the maximally tolerated dose of resiniferatoxin administered in the knee joint for the reduction of moderate to severe pain
signal intensity associated with osteoarthritis. The study is a dose-escalation protocol in which cohorts of patients will
receive increasing doses of resiniferatoxin until the maximum tolerated dose (MTD) is achieved. The primary objective of the study
is to evaluate the safety of resiniferatoxin and identify the recommended phase 2 dose. The secondary objective is to assess the
preliminary efficacy of resiniferatoxin measured by assessing changes in the intensity of pain using the WOMAC Index, a widely used
proprietary validated pain questionnaire.
Resiniferatoxin is not approved by regulatory authorities. Safety and efficacy have not been established.
More information on this trial can be found at www.clinicaltrials.gov (NCT03542838).
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 IB trial in terminal cancer patients 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.
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1 GlobalData Epicast (2017 report) states for year 2016: 17M cases of symptomatic hand OA (7 Major Markets, 7.6M in
the USA) + 15.2M symptomatic Knee OA (4.4M in the US) + 3.34M symptomatic hip OA (1.7M in the US).
2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC398431/
3 Sorrento Therapeutics (Ark Animal Health) internal data (on file).
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). 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
PTVA-OA-001 study or trial and any prior RTX studies in animals; the clinical and commercial success of RTX; the viability and
success of using RTX for treatments in certain therapeutic areas, including osteoarthritis (OA) 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, 2017, 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 Corporate Development
Telephone: 1.858.203.4120
Email: 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.
© 2019 Sorrento Therapeutics, Inc. All Rights Reserved.
