Cali Biosciences Completes Enrollment in Phase 3 Studies
for CPL-01 (Long-Acting ropivacaine)
SAN DIEGO, February 11, 2025 -- Cali Biosciences Co., Ltd. (hereinafter referred to as “Cali Biosciences”), a biotechnology company dedicated to the research and development of innovative drugs, announced that is has completed enrollment in both of its Phase 3 studies for CPL-01, a long-acting formulation of ropivacaine. This sets the stage for the company to submit its New Drug Application (NDA) to both the US FDA, the China CDE, and potentially other Regulatory agencies for approval across the globe to treat acute postoperative pain management, providing analgesia and reducing or avoiding opioid use for up to 72 hours after single-use administration via infiltration into the surgical site.
CPL-01 will be submitted as a 505(b)(2), capitalizing on Cali Biosciences’ being named “Company of the Year” by the 505(b)(2) Platform last year. Dr. Erol Onel, the company’s Chief Medical Officer, stated, “This milestone is certainly something to celebrate…now we can focus on getting the documents ready for Regulatory submission, the next step in our journey to help patients.” Scott Schwartz, Arizona Research Center CEO and Dr. Louise Taber, one of the AZRC’s primary investigators, both agree, stating “despite comparing the investigational drug to both placebo and active controls, results of the Phase 2 studies were absolutely pitch perfect. We are eagerly anticipating great success in Phase 3, and are so proud that we have been able to help Cali Biosciences move CPL-01 forwards.”
New Article
So pleased at the publication of our latest article, CPL-01, an investigational long-acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair, in the journal Hernia. Open access available here: https://doi.org/10.1007/s10029-024-03047-3. Enjoy!
Another Presentation
Honored to be presenting data from Cali Biosciences…
https://www.linkedin.com/posts/cali-biosciences_cali-biosciences-shines-with-cpl-01-presentation-activity-7117037832640040960-iGVj?utm_source=share&utm_medium=member_desktop
Honored
Pleased to be quoted in this Press Release…
Dr. Todd Bertoch, an anesthesiologist who has participated in clinical trials of other prior long-acting local anesthetics and a principal investigator in this study, said, "The fact that all available slots filled in just a few weeks is a tribute to the organization and care that CaliBio brings to organizing and executing on these studies, while also speaking to the unmet need of having a safe and effective long-acting ropivacaine with a broad approval.” Dr. Erol Onel, Chief Medical Officer of CaliBio US who has developed several other long-acting local anesthetics, agreed, "A successful trial in a bony surgery, like bunionectomy, will build on our already demonstrated success from our prior hernia and abdominoplasty trials. This should continue to help patients control or eliminate their post-operative pain, while decreasing any need for opioids."
Such an important project to fight the opioid crisis…
Monk
You’ve got to dig it to dig it, you dig?
A quote from Thelonius Monk, one of the greatest Jazz pianists. But also a great musical mind, and a bit of a philosopher who beautifully shows how science and the arts are related. Read some of his writings. Listen to some of his rhythms. You’ll thank me….
Thanks
Appreciate the recent acknowledgement for work done with Cali Biosciences on developing another long-acting local anesthetic to stem the tide of the opioid crisis…
Dr. Todd Bertoch, an anesthesiologist who has participated in clinical trials of prior long-acting local anesthetics and a principal investigator in this study, said, "This is an important step; ropivacaine is generally considered safer than bupivacaine, and there are no long-acting ropivacaine options currently available to help our patients with their post-operative pain." Dr. Erol Onel, Chief Medical Officer at CaliBio who has developed several other long-acting local anesthetics, agreed, "We need to do all that we can to help patients control or eliminate their post-operative pain, while continuing to chip away at the opioid crisis."
Next Steps
We all come to tipping points. How to determine which way to turn? It can’t simply be following the crowd, but reflexively taking the road less traveled by is just as bad. Think. Read. Analyze the data. The truth - your truth - is in there. It’s up to you to find it. We can help….
Light?
We’ve all heard the phrase “there’s a light at the end of the tunnel.” Looks like we are getting there in the fight against Covid-19. With the tremendous research that has taken place, the vaccine choices and new technologies that enabled them have given us multiple weapons against the variants. So long as people continue to be vigilant, and not let their guard down too much too soon, we should be able to anticipate the dawning of a more normal day….
Blog Post One
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