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Pacira BioSciences to Present 104-Week Efficacy Data Following a Single Local Administration of PCRX-201 for Patients with Mild to Severe Osteoarthritis of the Knee

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Pacira BioSciences (Nasdaq: PCRX) has announced the upcoming presentation of new 104-week efficacy data for their gene therapy candidate PCRX-201 (enekinragene inzadenovec) at the 2025 OARSI World Congress in Incheon, South Korea.

The presentation, titled 'Improvements in Pain, Stiffness, and Function After a Single Intraarticular Injection of Gene Therapy PCRX-201 for Knee Arthritis Osteoarthritis: A Subgroup Analysis by Structural Severity,' will be delivered by Professor Ali Mobasheri from the University of Oulu and State Research Institute Centre for Innovative Medicine.

The data demonstrates results following a single local administration for patients with mild to severe osteoarthritis of the knee. The presentation is scheduled for April 25 and 26, 2025, from 3:30-4:15 PM KST.

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-- Poster to be presented at OARSI World Congress on Osteoarthritis --

BRISBANE, Calif., April 22, 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 the upcoming presentation of new 104-week data in support of its locally administered gene therapy candidate, PCRX-201 (enekinragene inzadenovec). The data is being presented at the 2025 Osteoarthritis Research Society International (OARSI) World Congress in Incheon, South Korea, April 24-27.

Presentation Title: Improvements in Pain, Stiffness, and Function After a Single Intraarticular Injection of Gene Therapy PCRX-201 for Knee Arthritis Osteoarthritis: A Subgroup Analysis by Structural Severity

Presented By: Ali Mobasheri, Professor of Musculoskeletal Biology at the University of Oulu in Oulu, Finland; Chief Researcher and International Adviser in the State Research Institute Centre for Innovative Medicine in Vilnius, Lithuania

Date and Time: Friday, April 25 and Saturday, April 26 from 3:30-4:15 PM KST

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 are the key findings from PCRX-201's 104-week knee osteoarthritis trial?

The complete findings will be presented at the 2025 OARSI World Congress, focusing on improvements in pain, stiffness, and function following a single intraarticular injection of PCRX-201 for knee osteoarthritis patients.

How is PCRX-201 administered for knee osteoarthritis treatment?

PCRX-201 is administered as a single local intraarticular injection for patients with mild to severe osteoarthritis of the knee.

When will Pacira BioSciences present the PCRX-201 gene therapy data?

The data will be presented on April 25 and 26, 2025, from 3:30-4:15 PM KST at the 2025 OARSI World Congress in Incheon, South Korea.

What type of patients were included in the PCRX-201 clinical trial?

The trial included patients with mild to severe osteoarthritis of the knee, with results analyzed by structural severity subgroups.

What is the full name of Pacira's gene therapy candidate PCRX-201?

PCRX-201's full name is enekinragene inzadenovec, a locally administered gene therapy candidate for knee osteoarthritis.
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