Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), announced
that review of early results from an on-going “declawed cat pain
trial” (run by its Ark Animal Health division) prompted management
to assign a high priority to exploring the use of resiniferatoxin
as a local nerve block injection for the control of neuropathic
post-amputation residual limb pain in humans. A full IND package is
being prepared for FDA submission in the second half of 2019.
Declawing is the amputation of the last digit in a cat’s paws.
Although currently falling out of favor, this procedure used to be
commonplace. The population of “aging amputee cats” living with the
sequalae of surgeries performed years ago is quite large making it
a valuable “model” when looking at residual limb pain which affects
about 30% of the 1.6 million American amputees, or phantom limb
pain which affects up to 70% of those human patients1.
“Chronic distal limb pain in declawed cats is common in varying
degrees, especially in older cats. For some, the pain is very
difficult to control and often causes limping, aggressive behavior,
litter box avoidance, and decreased quality of life. I was
elated that the veterinarians at ARK contacted me and showed
interest in helping treat this population of cats as they don’t
otherwise receive much attention. I was hopeful but still
cautiously optimistic that these cats could improve and be made
more comfortable. My expectations were met as both cats I
treated did well during the treatment and showed improvement that
lasted for months afterwards. I was initially hesitant since
the treatment involved anesthesia and direct injections in the paw
nerves. However, experiencing the cat’s improved demeanor and
reduction in negative behavior was worth the effort. Reducing
or eliminating the need for daily systemic medications positively
affected not only the cat’s quality of life, but also the
human-animal bond with the owner,” (Dr M, Feline Specialist,
Principal Investigator).
Nine cats that have been living for years with debilitating
neuropathic post-declaw pain were included to date in the on-going
ARK clinical trial. Every cat treated was considered a treatment
success at Day 28, regardless of dose group, as defined by FDA
Center for Veterinary Medicine guidance using a validated feline
pain and behavior scale (see figure 1). No failures noted through
Day 120, but only 2 cats have completed the follow-up visits so
far. Andy, the cat with the longest follow-up to date, is still
doing well and enjoying a much-improved quality of life 7 months
after treatment (see video).
For humans, Residual Limb Pain is a common and difficult to
control condition in amputees. Often the condition is managed with
the use of opioids despite the high potential for addiction and the
unclear long-term clinical benefits. Delivering RTX peripherally as
a nerve block just like what is done with local anesthetics, is an
easy and precise technique that puts the drug exactly in the area
we believe might be the most effective. Any convenient to
administer non-opioid solution that could provide long-term relief
to amputees and potentially reduce the use for drugs or more
complex procedures in their pain control strategy, would address a
clear unmet need for that patient population.
“We are looking at RTX in cats as a good long-term pain control
approach given that felines do not tolerate non-steroidal
anti-inflammatory drugs well (there are no NSAIDs approved in cats
for chronic use) and opioids are not a viable approach for daily at
home pain control. The local nerve block as a route of
administration for RTX presents numerous advantages and a
convenient way for veterinarians to help their feline patients
without relying on off-label chronic use of daily oral medications.
Given the clear clinical benefits we have seen in cats, and
confirmed in some dogs, we decided to explore the same direct nerve
application approach for the RTX human clinical development
program,” stated Alexis Nahama, DVM, President of Ark Animal Health
and Head of the RTX program.
“In addition to our marketed product ZTlido® (lidocaine topical
system) 1.8% for postherpetic neuralgia and our Phase 3 SP-102
product for sciatica back pain, RTX provides another powerful tool
in our expansive arsenal of non-opioid pain management,” added Dr.
Henry Ji, Chairman and CEO of Sorrento Therapeutics. “The clinical
data generated by our animal health division is very exciting and
motivates us to accelerate the work needed to file a human IND
later this year. We hope to confirm the long-term potential of RTX
in helping control residual limb pain and assess the clinical
benefits in reducing phantom limb pain in people”.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/a98449dc-9b89-416f-a9e1-2dd09cb33663
* CSOMf. Validated Scale taking into account 3 pet owner
selected parameters measured (from 1 to 5) over time. Success
defined as a reduction of at least 2 in total CSOMf score compared
to Day 0 with no increase in any individual activities. Two treated
cat patients were followed at Day 90 and one at Day 120.
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 patients. Delivered peripherally (into the joint
space, the epicardial space or as a nerve block) the transient
nerve ending ablation effect can have profound clinical benefits
lasting for months to years (as shown in canine joint pain
studies). Delivered spinally the effect can be profound and lasting
(as shown in canine cancer pain studies).
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 cancer
patients and Osteoarthritis (OA) patients is also demonstrated by
its effort to advance Resiniferatoxin (“RTX”), a first-in-class
(TRPV1 agonist) non-opioid pain management small molecule, ZTlido®
and SP-102, a non-opioid corticosteroid gel. Resiniferatoxin is
completing a Phase 1b trial in terminal cancer patients and a Phase
1b trial for OA. ZTlido was approved by US FDA on 02/28/18. SP-102
is in Phase 3 pivotal study for the treatment of lumbar radicular
pain/sciatica.
For more information visit www.sorrentotherapeutics.com
More information on Sorrento clinical trials can be found at
www.clinicaltrials.gov
About Ark Animal Health, Inc.
Ark Animal Health is a wholly owned subsidiary of Sorrento
Therapeutics, Inc. The company was formed in 2014 to bring to the
companion animal market innovative solutions issued from Sorrento’s
human research and development activities. Ark is shifting the
paradigm of treatment of veterinary pain management with the
development of a multi-species multi-indications resiniferatoxin
(RTX), a purified chemical originally discovered in cactus-like
Euphorbia plants with unique properties and potential to help treat
previously intractable pain. This ultra-potent non-opioid molecule
selectively binds to and deletes the afferent nerves responsible
for transmitting the chronic inflammatory pain signals to the
brain. The company’s lead program evaluating RTX for the control of
canine pain associated with bone cancer, has received FDA/CVM MUMs
designation (orphan type designation). Other pipeline projects
include indications for RTX in chronic articular pain in companion
animals, neuropathic pain in horses, and idiopathic cystitis in
cats. Development opportunities leveraging Sorrento human
immuno-oncology expertise and clinical assets (antibodies,
oncolytic virus, cell therapies) are being assessed for translation
into the companion animal health market.
For more information about Ark Animal Health or Sorrento’s
translational program visit http://www.arkanimalhealth.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. and Ark Animal Health, 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), ZTlido® (lidocaine topical system) 1.8% for
postherpetic neuralgia and our Phase 3 SP-102 product for sciatica
back pain. 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,
ZTlido® (lidocaine topical system) 1.8% for postherpetic neuralgia
and our Phase 3 SP-102 product for sciatica back pain; risks
related to seeking regulatory approvals and conducting and
obtaining results of clinical trials, including, but not limited
to, any prior RTX studies in animals; the clinical and
commercial success of RTX and SP-102; the viability and success of
using RTX for treatments in certain therapeutic areas, including
cardiovascular diseases and osteoarthritis, ZTlido® (lidocaine
topical system) 1.8% for postherpetic neuralgia pain, our Phase 3
SP-102 product for sciatica back pain 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, DVM
Head of RTX Program and President ARK Animal Health
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.
References:
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3198614/
A video accompanying this announcement is available
at https://www.globenewswire.com/NewsRoom/AttachmentNg/929fa479-a377-4f60-87da-49c7e0ff8fd5
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