SAN
DIEGO, May 21, 2024 /PRNewswire/ -- Cali
Biosciences Co., Ltd. (hereinafter referred to as "Cali
Biosciences"), a biotechnology company dedicated to the research
and development of innovative drugs, announced publication of
"CPL‑01, an investigational long‑acting ropivacaine, demonstrates
safety and efficacy in open inguinal hernia repair" in the
scientific journal Hernia. The article's authors are
Hanghang Tommy Xu, John Zimmerman,
Todd Bertoch, Lee Chen, PJ Chen, and Erol Onel.
"Recognition of the importance of these results by an esteemed
journal such as Hernia is an important moment for Cali
Biosciences," commented lead author, Dr. Tommy Xu. "In this study, our
investigational drug CPL-01 out-performed not only placebo, but
also standard of care Naropin®, with a clinically meaningful
decrease in pain over 72 hours despite using half the
opioids." Dr. Erol Onel, the
Chief Medical Officer of Cali Biosciences US, LLC, agreed: "While
there are several long-acting local anesthetics based on
bupivacaine currently available, CPL-01 is based on ropivacaine,
which is believed to be safer." The study's lead PI, Dr.
Todd Bertoch, reiterated the safety
of CPL-01, recounting the lack of serious adverse events in the
dose advanced to Phase 3 and agreeing that "the advantages of a
more effective and safer long-acting local anesthetic are obvious,
and the ability to keep patients out of severe pain and towards an
opioid-free recovery benefits society, the hospital systems, and of
course the patients themselves."
PJ Chen, the CEO of Cali Biosciences, emphasized that "along
with our soon-to-be published successful Phase 2 bunion study,
these results are incredibly encouraging and we are hopeful that
our Phase 3 results will be as successful, leading to positive news
from the regulatory authorities. When combined with our other
pipeline products in the peri-operative space, Cali
Biosciences is positioned to be a leader in this area with a
suite of products that could help serve doctors and patients around
the world."
The publication may be accessed here: CPL-01, an investigational
long-acting ropivacaine, demonstrates safety and efficacy in open
inguinal hernia repair | Hernia (springer.com).
About CPL-01
CPL-01 is a sustained-release injectable formulation of
Naropin® (ropivacaine hydrochloride). Ropivacaine is a member
of the amide class of local anesthetics indicated for the
production of local or regional anesthesia for surgery and acute
pain management. Naropin® injection is approved for local or
regional anesthesia for surgery and for acute pain management.
However, because of the short duration of effect of the traditional
Naropin®, infusion by catheter is required if protracted local
analgesia is needed for postoperative pain management. Based on the
formulation of Naropin®, Cali Biosciences has applied PG-Depot, a
versatile drug delivery platform, in developing CPL-01 to prolong
the duration of analgesic effect at local site after a single local
administration.
About Cali Biosciences
Cali Biosciences Co., Ltd. was established in Cayman
Islands in 2021. Cali Biosciences US, LLC was established
in San Diego in 2016, and later Cali Biosciences built its
global headquarter in Shenzhen. Cali Biosciences is a
biotechnology company dedicated to the research and development of
pain management drug candidates based on its drug delivery
platforms and other patented technologies, with a view to extending
the coverage to manufacturing and commercialization of the
pharmaceutical products it develops. The product pipeline of Cali
Biosciences currently focuses on non-opioid post-operative pain
management including analgesia, anesthesia, sedation, and control
of inflammation. Cali Biosciences is committed to responding to
unmet medical needs and serving patients and medical professionals
around the world.
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SOURCE Cali Biosciences