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Clinical Trial News

Pacira BioSciences Partners with Johnson & Johnson to Expand Zilretta Access for Osteoarthritis Knee Pain

  • Pacira BioSciences has entered a strategic co-promotion agreement with Johnson & Johnson MedTech to expand distribution of Zilretta, the first FDA-approved extended-release intra-articular therapy for osteoarthritis knee pain.
  • The collaboration will leverage Johnson & Johnson's specialized sales team to target broader physician specialties including sports medicine, pain management, and rheumatology beyond traditional orthopedic practices.
  • Zilretta provides extended pain relief for up to 16 weeks and could potentially reach a significant portion of the seven million intra-articular knee injections administered annually in the U.S.
  • The partnership aligns with Pacira's 5x30 growth strategy and Johnson & Johnson's mission to advance orthopaedic care with non-opioid pain management solutions.

Stanford Researchers Develop Radiation-Free Stem Cell Transplant Protocol for Fanconi Anemia Patients

Monoclonal AntibodyRare Disease
  • Stanford Medicine researchers successfully conducted stem cell transplants in three Fanconi anemia patients using the anti-CD117 antibody briquilimab, eliminating the need for toxic radiation or busulfan chemotherapy.
  • All three pediatric patients achieved nearly 100% donor cell engraftment after two years, far exceeding the initial 1% target, with no graft rejection or major complications.
  • The innovative protocol addresses donor shortage by allowing transplants from half-matched donors like parents through alpha/beta T-cell depletion techniques.
  • Researchers are now conducting phase 2 trials and exploring applications for other genetic diseases including Diamond-Blackfan anemia and elderly cancer patients.

STRIDE Immunotherapy Achieves Unprecedented 19.6% Five-Year Survival Rate in Advanced Liver Cancer

  • A new exploratory analysis of the HIMALAYA phase III trial shows that 19.6% of patients with unresectable hepatocellular carcinoma treated with STRIDE immunotherapy remained alive after five years, compared to 9.4% with sorafenib.
  • STRIDE represents the first phase III study to report five-year overall survival data in advanced liver cancer, establishing a new survival benchmark for this devastating disease.
  • The combination therapy demonstrated sustained survival benefits across all clinically relevant patient subgroups with manageable safety and no new late-onset serious side effects.
  • These findings represent a clinical breakthrough that was considered unimaginable just a few years ago and will inform treatment decisions for years to come.

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/11/2017

HMNC Brain Health and Spruce Biosciences Launch Phase 2 Trial for Precision Depression Treatment

Precision Medicine
  • HMNC Brain Health and Spruce Biosciences have dosed the first patient in the Phase 2 TAMARIND trial, evaluating tildacerfont as a precision treatment for major depressive disorder.
  • The trial targets a biologically distinct subtype of MDD patients with HPA axis dysregulation, using HMNC's proprietary genetic marker-based patient selection tool.
  • Tildacerfont, a CRF1 receptor antagonist, has the potential to address up to 50% of MDD patients worldwide through personalized medicine approaches.
  • The randomized, double-blind, placebo-controlled study will enroll 88 adults across eight UK sites, with topline results expected in the first half of 2026.

Real-World Study Shows Adalimumab Biosimilar IBI303 Matches Humira Efficacy with Superior Cost Benefits in Ankylosing Spondylitis

Real World Evidence
  • A retrospective study of 106 patients with ankylosing spondylitis in China found IBI303 biosimilar demonstrated comparable safety to Humira with higher retention rates at 52 weeks (63% vs 44%).
  • Treatment costs were significantly lower for IBI303 patients compared to Humira at both 12 weeks ($762.20 vs $903.70) and 52 weeks ($2543.00 vs $2982.30).
  • Safety profiles were nearly identical between groups, with only 2 patients in each group experiencing mild infusion-related reactions and no statistically significant differences in adverse events.
  • The findings support IBI303 as a cost-effective first-line treatment option that could expand access to adalimumab therapy while maintaining clinical effectiveness.

Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis

NCT02893254CompletedPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 9/22/2016

FDA Rejects Replimune's Melanoma Drug Amid Evolving Regulatory Standards

FDA ApprovalOncology
  • The FDA rejected Replimune's melanoma drug in a complete response letter, citing inadequate single-arm study design and patient enrollment differences as key concerns.
  • The agency questioned whether the single-arm study provided substantial evidence of effectiveness and raised issues with the company's confirmatory trial design.
  • Analysts interpret the rejection as evidence of changing FDA approval standards, with Replimune CEO expressing surprise at the decision given prior agency meetings.
  • The rejection highlights the evolving regulatory landscape for oncology drug approvals, particularly for single-arm studies in melanoma treatment.

NanoKnife System Shows Promise for Prostate Cancer Treatment in PRESERVE Trial

  • The PRESERVE trial demonstrated that irreversible electroporation with the NanoKnife System achieved a 71% negative in-field biopsy rate at 12 months in patients with intermediate-risk prostate cancer.
  • The treatment preserved quality of life outcomes, with 96% of patients remaining pad-free and 84% of patients with good baseline sexual function maintaining erections sufficient for penetration at 12 months.
  • The FDA granted 510(k) clearance for the NanoKnife System for prostate tissue ablation in December 2024 based on these trial results.
  • The non-thermal ablation technology offers a minimally invasive alternative to traditional whole-gland therapies while maintaining strong safety profile with most adverse events being grade 1-2.

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue

NCT04972097CompletedNot Applicable
Angiodynamics, Inc.
Posted 3/29/2022

SINTX Technologies Submits FDA 510(k) for Silicon Nitride Foot and Ankle Implants

  • SINTX Technologies has submitted a 510(k) premarket notification to the FDA for silicon nitride osteotomy wedges, marking the company's entry into the foot and ankle reconstruction market.
  • The implants are manufactured from proprietary medical-grade silicon nitride, which has demonstrated pro-osteogenic properties, antimicrobial activity, and superior radiographic clarity compared to traditional materials like PEEK and titanium.
  • The devices leverage over a decade of clinical experience with silicon nitride, including more than 50,000 spinal interbody fusion devices implanted since 2008.
  • The foot and ankle fusion market is valued at approximately $750.5 million and is expected to grow to $1.38 billion by 2032, representing a significant commercial opportunity for SINTX.

Radiopharm Theranostics Appoints Leading Prostate Cancer Expert Dr. Oliver Sartor to Scientific Advisory Board

Oncology
  • Radiopharm Theranostics has appointed Dr. Oliver Sartor, an internationally recognized medical oncologist specializing in prostate cancer and radiopharmaceutical therapies, to its Scientific Advisory Board.
  • Dr. Sartor currently serves as Director of Radiopharmaceutical Clinical Trials at Mayo Clinic and has led multiple pivotal Phase 3 trials resulting in FDA approvals for radiopharmaceutical therapies.
  • The appointment strengthens Radiopharm's clinical expertise as the company advances its radiopharmaceutical pipeline, which includes one Phase 2 and three Phase 1 trials across various solid tumor cancers.

BioVie Strengthens Board with Neuroscience and Finance Veterans as Bezisterim Advances Through Phase 2 Trials

  • BioVie Inc. appointed Amy S. Chappell, MD, FAAN, and Kameel D. Farag to its Board of Directors to support the company's neurological and liver disease drug development programs.
  • Dr. Chappell brings 25 years of CNS drug development experience at Eli Lilly, including FDA approvals for Cymbalta in fibromyalgia and musculoskeletal pain indications.
  • The appointments coincide with BioVie's ongoing Phase 2 trials of bezisterim for early Parkinson's disease and long COVID, plus advancing Alzheimer's disease and liver cirrhosis programs.
  • Farag's financial expertise includes securing over $150 million in financing at Aspen Neuroscience and scaling operations at major pharmaceutical companies like Ionis and Amgen.

NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa

NCT05083260CompletedPhase 1
BioVie Inc.
Posted 1/4/2022

A Phase 3 Study of NE3107 in Probable Alzheimer's Disease

NCT04669028CompletedPhase 3
BioVie Inc.
Posted 8/5/2021

Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia

NCT05227820CompletedPhase 2
Neurological Associates of West Los Angeles
Posted 1/19/2022

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