Pacira BioSciences to Present New Data on Clinical Immunogenicity of Intra-Articular PCRX-201 and Its Implications for Dosing Strategy in Knee Osteoarthritis

Rhea-AI Summary

Pacira BioSciences (NASDAQ: PCRX) announced it will present findings from its Phase 1 study of PCRX-201, a gene therapy candidate for knee osteoarthritis, at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) on May 15, 2025. The presentation will focus on how neutralizing antibodies (NAbs) affect the therapy's efficacy, safety, and potential for redosing.

Dr. MiJeong Kim, Senior Director of Translational Sciences, will deliver the presentation titled "Understanding the Clinical Immunogenicity of Locally Injected HCAd Vector Provides Insight into Optimizing Dosing Strategy." Additionally, Pacira will host a symposium on High-Capacity Adenoviral Vectors (HCAd) for common diseases, featuring speakers from Baylor College of Medicine and Pacira's development team.

Data will be featured at the ASGCT 28th Annual Meeting

BRISBANE, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced an upcoming podium presentation of findings from its Phase 1 study of PCRX-201 (enekinragene inzadenovec), a locally administered gene therapy candidate for osteoarthritis of the knee. The data will be presented at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in New Orleans on May 15. The presentation will highlight how preexisting and treatment-induced neutralizing antibodies (NAbs) impact the therapy’s efficacy, safety, and redosing potential.

Presentation Title: Understanding the Clinical Immunogenicity of Locally Injected HCAd Vector Provides Insight into Optimizing Dosing Strategy

Presented By: MiJeong Kim, PhD, Senior Director of Translational Sciences at Pacira BioSciences

Date and Time: Thursday, May 15 from 2:15–2:30 PM CT, during the “Immunogenicity/NAb Titers” oral session at ASGCT 2025

Pacira will also host a symposium on HCAd for common diseases, like osteoarthritis.

Symposium Title: High-Capacity Adenoviral Vectors: Advancing Gene Therapy Beyond AAV to Deliver Cost-Effective Therapies for Common Diseases

Speakers:

• Brendan Lee, Professor of Molecular and Human Genetics, Baylor College of Medicine
• Derek Jackson, Vice President, Cell & Gene Therapy Product Development at Pacira BioSciences
• Kilian Guse, Development of Gene Therapy for Musculoskeletal Disorders at Pacira BioSciences
  

Date and Time: Friday, May 16 from 12:15–1:15 PM CT

About PCRX-201 (enekinragene inzadenovec)
PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today.

In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee – a testament to its promise and potential.

Given the promising Phase 1 results, dosing is underway in a Phase 2 study of PCRX-201 (the ASCEND study) for the treatment of knee osteoarthritis. To learn more about PCRX-201 and the company’s clinical development program, please visit the investor events section of the company’s investor website.

About Pacira
Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL^® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA^® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera_®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The Company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel, locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com.

Investor Contact:
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com 

Media Contact:
Sara Marino, (973) 370-5430
sara.marino@pacira.com 

FAQ

What will Pacira BioSciences (PCRX) present at ASGCT 2025?

Pacira will present Phase 1 study findings of PCRX-201, their gene therapy candidate for knee osteoarthritis, focusing on neutralizing antibodies' impact on efficacy, safety, and redosing potential.

When and where will PCRX present their PCRX-201 gene therapy data?

The presentation will take place on May 15, 2025, from 2:15-2:30 PM CT at the ASGCT 28th Annual Meeting in New Orleans.

Who will present the PCRX-201 data at ASGCT 2025?

Dr. MiJeong Kim, Senior Director of Translational Sciences at Pacira BioSciences, will present the data.

What additional event is Pacira hosting at ASGCT 2025?

Pacira will host a symposium on High-Capacity Adenoviral Vectors (HCAd) for common diseases on May 16, featuring speakers from Baylor College of Medicine and Pacira's development team.