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Clinical Trial News

Mesoblast Secures $50 Million Funding Option Contingent on Ryoncil FDA Approval

  • Mesoblast has entered into a convertible note agreement with its largest shareholder for up to $50 million, pending FDA approval of Ryoncil.
  • The funding will support the commercial launch of Ryoncil for treating children with steroid-refractory acute graft versus host disease (SR-aGvHD).
  • The convertible notes have a 5% annual coupon and a conversion price of $9.06 per American Depository Receipt (ADR).
  • FDA decision on Ryoncil is anticipated by January 7, 2025, which aligns with Mesoblast's commercialization strategy.

Cutia Therapeutics' CU-20401 Completes Phase II Trial for Submental Adipose Accumulation

• Cutia Therapeutics has completed a Phase II clinical trial in China for CU-20401, a novel drug targeting submental adipose accumulation. • CU-20401 utilizes a unique mechanism to reduce localized fat by targeting the extracellular matrix of adipose tissue. • The Phase II trial was a multi-center, randomized, double-blind, and placebo-controlled study evaluating CU-20401's efficacy and safety. • CU-20401 is a recombinant mutant collagenase, modified to reduce adverse effects, that promotes adipocyte apoptosis by degrading extracellular matrix collagen.

Medidata Clinches Two Excellence Awards for Innovative Clinical Trial Solutions

  • Medidata's Health Record Connect wins Innovation Award for its groundbreaking interoperability engine that streamlines EHR data acquisition across healthcare organizations, enabling faster clinical trial processes.
  • Clinical Data Studio earns Product Launch Award by demonstrating up to 80% reduction in data review times and 50% decrease in patient profile reviews through AI-powered data management.
  • As part of Dassault Systèmes, Medidata continues to transform clinical research with digital solutions, supporting over 34,000 trials and 10 million patients in its 25-year history.

FDA Approves Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic and Non-Small Cell Lung Cancers

• The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced unresectable or metastatic NRG1+ pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC). • Bizengri is the first and only FDA-approved therapy specifically targeting NRG1 gene fusions in these cancers, offering a new treatment option for patients with disease progression after prior systemic therapy. • Approval was based on overall response rate (ORR) and duration of response (DOR) data from the eNRGy trial, with continued approval contingent on confirmatory trial results. • Bizengri carries a Boxed Warning for Embryo-Fetal Toxicity and warnings for infusion-related reactions, interstitial lung disease/pneumonitis, hypersensitivity/anaphylactic reactions and left ventricular dysfunction.

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

NCT02912949Active, Not RecruitingPhase 2
Partner Therapeutics, Inc.
Posted 1/1/2015

HDAC Inhibition in Muscle Cells Enhances Bone Regeneration via Extracellular Vesicles

  • Histone deacetylase (HDAC) inhibition using Trichostatin A (TSA) in human skeletal muscle myoblasts (HSMMs) promotes myotube formation and myogenic gene expression.
  • Extracellular vesicles (EVs) from TSA-treated HSMMs (TSA-EVs) exhibit enhanced properties and prevent ovariectomized-induced bone loss in mice, increasing bone mineral density.
  • TSA-EVs promote osteogenic differentiation of human bone marrow mesenchymal stem cells (hBMSCs) and inhibit osteoclast formation, highlighting their potential for bone regeneration.
  • TSA treatment mimics exercise effects on bone formation by upregulating miR-873-3p in EVs, which targets CNN2 to promote osteogenesis in hBMSCs.

Combination Therapy Shows Promise in Oligometastatic Prostate Cancer

• A phase 2 trial (SHARP) indicates that combining radium-223 dichloride with stereotactic body radiation therapy (SBRT) and ADT is well-tolerated for mCSPC. • The SHARP trial observed a median progression-free survival (PFS) of greater than 21 months in treated patients with mCSPC. • MRI-guided SBRT demonstrates lower rates of genitourinary and gastrointestinal toxicity compared to CT-guided SBRT for prostate cancer. • The RAVENS study found that adding radium-223 to SABR did not delay disease progression in bone-metastatic oligometastatic hormone-sensitive prostate cancer.

Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

NCT03361735Active, Not RecruitingPhase 2
City of Hope Medical Center
Posted 8/29/2018

Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

NCT03380806Unknown StatusPhase 2
Juravinski Cancer Center
Posted 1/1/2019

RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers

NCT04037358Active, Not RecruitingPhase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Posted 8/9/2019

Stereotactic Body Radiation for Prostate Oligometastases

NCT02680587CompletedPhase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Posted 4/28/2016

Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer

NCT01558427CompletedPhase 2
University Hospital, Ghent
Posted 8/1/2012

Prostate Advances in Comparative Evidence

NCT01584258Active, Not RecruitingPhase 3
Royal Marsden NHS Foundation Trust
Posted 8/7/2012

BART Trial: Adjuvant Radiotherapy Shows Tolerable Toxicity Profile in Bladder Cancer

  • The BART trial investigated adjuvant radiotherapy (ART) following radical cystectomy and chemotherapy in high-risk muscle-invasive bladder cancer (MIBC).
  • Results indicated that ART did not significantly increase severe acute or late toxicity compared to observation alone.
  • Grade 2 acute toxicities, mainly bowel-related, were more frequent in the ART arm but resolved without intervention.
  • The study suggests ART is a safe and tolerable option for MIBC, with ongoing assessment for oncological efficacy.

Ultrahypofractionated Radiotherapy Shows Promise in Post-Prostatectomy Salvage Setting

• A prospective trial evaluated ultrahypofractionated radiotherapy (SBRT) post-prostatectomy for localized prostate cancer, showing it is well-tolerated by patients. • The study reported no grade ≥3 acute genitourinary or gastrointestinal toxicities, suggesting a favorable acute safety profile for the treatment approach. • Health-related quality of life impact was minimal in the acute phase, though longer follow-up is needed to assess long-term toxicity and efficacy. • A multicenter study with a larger cohort has completed enrollment to further validate the safety and efficacy of this radiotherapy modality.

Novel Therapies and Biomarkers Reshape Bladder Cancer Treatment Strategies

  • Immunotherapy and antibody-drug conjugates (ADCs) are transforming urothelial carcinoma treatment, prompting investigation into bladder-sparing approaches.
  • Ongoing trials are evaluating combinations of ICIs or ADCs with trimodal therapy (TMT) in muscle-invasive bladder cancer (MIBC) patients.
  • Predictive biomarkers like ERCC2 mutations and ctDNA levels show promise in tailoring treatment and predicting outcomes in MIBC.
  • Combining ADCs with radiation therapy demonstrates potential in preclinical studies, warranting further clinical investigation for enhanced efficacy.

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