Clinical Trial News

Speakers at the 2024 World Conference on Lung Cancer highlighted the use of new technologies and emerging end points in clinical trials, emphasizing the importance of relationships with investigators, patients, and families. They discussed the evolving role of end points like event-free survival and pathologic complete response, and the need for advanced technology in standardizing trial design. Successful trial design requires pragmatic and adaptive protocols, and strong relationships are crucial for patient participation and trial success.

PharmAla Biotech Holdings Inc. contracted as MDMA supplier for Johns Hopkins Medicine clinical trial. CEO Nicholas Kadysh highlights PharmAla's unique position to meet GMP MDMA quality standards. PharmAla terminates agreement with Red Light Holland on September 3, 2024. Selected to present novel molecule APA-01 at EBPS Workshop on September 26th. PharmAla focuses on research, development, and manufacturing of MDXX class molecules, including MDMA, aiming to alleviate global backlog and develop novel drugs.

Nippon Shinyaku received rare pediatric disease designation for NS-050/NCNP-03, developed for Duchenne muscular dystrophy. NS-050/NCNP-03, an antisense oligonucleotide, aims to treat patients with gene mutations amenable to exon 50 skipping therapy, producing a functional dystrophin protein to suppress muscle function deterioration. Clinical trials are being prepared in Japan and the U.S.

Theradaptive's Phase I/II OASIS Trial treats first patient with OsteoAdapt SP in spinal fusion, aiming to improve safety and effectiveness over autologous bone graft. OsteoAdapt SP, containing next-gen protein AMP2, targets degenerative disc disease and offers potential benefits in various medical fields.

Dana-Farber Cancer Institute presents novel breast cancer treatments and quality of life research at ESMO Congress 2024, including studies on targeted therapies and antibody-drug conjugates. Key presentations include Ann Partridge on unintended consequences of cancer care, Nancy Lin on DESTINYBreast-12, and Toni Choueiri on renal cell carcinoma. Other studies cover vitamin D supplementation, HIF-2α inhibitors, and supportive care interventions.

PainReform Ltd. announced positive compatibility results of PRF-110 with both non-absorbable and resorbable sutures, confirming its safety and efficacy in post-surgical pain management.

SS Innovations plans to submit its SSi Mantra Surgical Robotic System for FDA approval via a de novo pathway, aiming for clinical trials in Q1 2025 and potential market approval by end of 2025.

Allergan Aesthetics launches BOTOX® Cosmetic for masseter muscle prominence (MMP) in China, supported by clinical trials showing effectiveness and safety. Plans include expanding MMP treatment to other global markets.

Nuance Pharma completes patient recruitment for ENHANCE-CHINA phase 3 trial of ensifentrine (Ohtuvayre™) for COPD treatment in China, following US FDA approval in 2024. The trial, led by Professor Zhong Nanshan, aims to evaluate efficacy and safety over 24 weeks in 46 hospitals.

TOFIDENCE (BAT1806/BIIB800) maintains comparable clinical efficacy, safety, and immunogenicity after switching from reference tocilizumab in TP2 (Week 24-48) for RA patients with inadequate MTX response, supporting its biosimilarity.