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Clinical Trial News

UK Labour Government's NHS Reform: AI and Technology at Forefront of 10-Year Healthcare Transformation Plan

• Lord Darzi's NHS report reveals critical healthcare challenges, including higher cancer mortality rates and delays in genomic testing, highlighting urgent need for system reform.
• Health Secretary Wes Streeting emphasizes shift towards predictive and preventative healthcare through advances in genomics, data analytics, and personalized medicine.
• Healthcare experts at HETT 2024 advocate for AI integration and technological adoption to transform patient care, calling for organizational openness to innovation and consistent long-term planning.

Daehwa Pharm's Oral Paclitaxel (Liporaxel) Approved in China for Gastric Cancer Treatment

  • Daehwa Pharm's Liporaxel, an oral formulation of paclitaxel, has received marketing approval from China's NMPA for treating gastric cancer.
  • Liporaxel utilizes Daehwa's DHLASED technology, offering improved convenience and safety compared to traditional intravenous paclitaxel.
  • Clinical trials demonstrated improved outcomes, particularly regarding hair loss and peripheral neuropathy, enhancing patient comfort.
  • Daehwa Pharm anticipates significant market penetration in China through its partnership with Haihe, expanding into other global markets.

Synergy Spine Solutions Completes Enrollment in Synergy Disc 2-Level IDE Clinical Trial

  • Synergy Spine Solutions has completed patient enrollment in its U.S. 2-Level IDE clinical trial for the Synergy Disc.
  • The trial evaluates the safety and effectiveness of the Synergy Disc compared to anterior cervical discectomy and fusion (ACDF) for degenerative disc disease.
  • The Synergy Disc features a lordotic core designed to maintain or restore sagittal alignment, potentially expanding TDR indications.
  • Anticipated FDA approval of the Synergy Disc will offer surgeons enhanced options for disc arthroplasty, increasing the overall disc replacement market.

Medidata Streamlines Clinical Trial Compensation with New Patient Payments Platform

  • Medidata has launched a comprehensive Patient Payments solution to automate and simplify reimbursements for clinical trial participants, covering expenses from travel to lost wages.
  • The new platform integrates with Medidata's existing e-clinical suite, leveraging AI to automate payment triggers based on trial activities and providing unified access through myMedidata and iMedidata portals.
  • This solution addresses a critical challenge in clinical research by enhancing participant experience and streamlining the financial management process for sites and sponsors.

Entera Bio and OPKO Health Announce Positive PK/PD Results for Oral Oxyntomodulin for Obesity and Metabolic Disorders

• Entera Bio and OPKO Health reported positive pharmacokinetic/pharmacodynamic (PK/PD) results for their oral oxyntomodulin (OXM) tablet candidate targeting obesity and metabolic disorders. • In vivo studies in rodent and pig models demonstrated significant systemic exposure and favorable bioavailability of oral OXM following a single dose. • Oral OXM significantly reduced plasma glucose levels in rats post-glucose administration compared to placebo, indicating potential pharmacologic effect. • The companies plan to present the data at an upcoming clinical conference and advance the program toward IND-enabling efforts.

TYRA-300: Novel FGFR3-Selective Inhibitor Shows Promise in Urothelial Cancer and Achondroplasia

  • TYRA-300 is a novel, orally available, and highly selective inhibitor of FGFR3, designed to minimize off-target toxicities associated with pan-FGFR inhibitors.
  • Phase 1 clinical trials are underway, evaluating TYRA-300 in patients with urothelial cancers and solid tumors harboring FGFR3 alterations.
  • Preclinical data suggest TYRA-300's potential to overcome gatekeeper resistance mutations, a common challenge with existing FGFR inhibitors.
  • Future Phase 2 studies are planned to investigate TYRA-300's efficacy in urothelial cancers and achondroplasia, a skeletal dysplasia caused by FGFR3 mutations.

Sanofi Expands Oncology Pipeline with CD73 Inhibitor Ulelimumab Collaboration

  • Sanofi partners with I-Mab to develop ulelimumab, a monoclonal antibody targeting CD73, for cancer treatment.
  • A pivotal study in China is evaluating ulelimumab with Loqtorzi in first-line NSCLC patients with PD-L1 and CD73-positive tumors.
  • Phase 1/2 trials showed a 63% ORR in NSCLC patients with high CD73 and PD-L1 expression when ulelimumab was combined with Loqtorzi.
  • The collaboration marks Sanofi's third oncology deal recently, focusing on innovative approaches in a competitive CD73-targeting landscape.

Anixa Biosciences Plans Phase II Trial for Breast Cancer Vaccine

  • Anixa Biosciences is set to launch a Phase II clinical trial for its breast cancer vaccine, administered before surgery.
  • The trial will evaluate the vaccine's efficacy alongside chemotherapy and pembrolizumab, aiming to reduce tumor burden and recurrence.
  • The study will assess the immunological response and compare outcomes of standard care alone versus the vaccine combined with standard care.
  • Scheduled to begin in 2025 and last 2-3 years, the trial follows promising Phase I results showing no safety concerns and immune responses.

YourChoice Therapeutics Doses First Participants in Phase Ia/IIb Trial of Hormone-Free Male Contraceptive Pill YCT-529

  • YourChoice Therapeutics has initiated a Phase Ia/IIb clinical trial of YCT-529, a hormone-free oral contraceptive for men.
  • The trial will evaluate the tolerability and impact on sperm count of YCT-529 in up to 50 male volunteers aged 28-70 years.
  • YCT-529 functions by inhibiting retinoic acid receptor-alpha (RAR-alpha) in the testes, preventing sperm production by restricting vitamin A access.
  • Preclinical studies suggest YCT-529 is as effective, or more so, than traditional female birth control pills, marking a potential innovation in male contraception.

Adicet's ADI-001 CAR-T Therapy Expands Clinical Trial to Include Idiopathic Inflammatory Myopathy and Stiff Person Syndrome

  • Adicet Bio's ADI-001, a CAR-engineered gamma delta T-cell therapy, has received FDA clearance to expand its Phase 1 trial to include idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS).
  • The Phase 1 trial will now include arms for lupus nephritis (LN) and SLE, systemic sclerosis (SSc), antineutrophil cytoplasmic autoantibody associated vasculitis (AAV), and IIM/SPS.
  • Clinical biomarker data from a previous trial indicated ADI-001's potential in autoimmune diseases, showing robust B-cell depletion and tissue trafficking.
  • Patient enrollment for the IIM and SPS arm is expected to begin in the first quarter of 2025, marking an expansion of Adicet's autoimmune disease program.

A Phase 1 Study of ADI-001 in Autoimmune Disease

NCT06375993RecruitingPhase 1
Adicet Therapeutics
Posted 11/10/2024

A Phase 1 Study of ADI-001 in B Cell Malignancies

NCT04735471TerminatedPhase 1
Adicet Therapeutics
Posted 3/4/2021

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