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Clinical Trial News

Persistent Tumor Hypoxia Predicts Distant Metastasis in Head and Neck Cancer

  • A cohort study of 281 HNSCC patients found persistent tumor hypoxia during chemoradiotherapy (CRT) significantly increases distant metastasis risk.
  • Patients with persistent hypoxia had a 3.5-fold higher risk of distant metastasis and worse overall survival compared to those without.
  • No patients with hypoxia-negative tumors before CRT experienced distant metastasis, suggesting its potential as a biomarker.
  • Findings support using 18F-fluoromisonidazole PET to identify high-risk patients for escalated therapies in HNSCC management.

CNP-104 Shows Promise in Phase 2a Trial for Primary Biliary Cholangitis

  • CNP-104 demonstrated a statistically significant decrease in liver stiffness compared to placebo in patients with primary biliary cholangitis (PBC).
  • The investigational therapy also showed favorable changes in pathogenic CD4 T cell populations and tolerance-inducing CD8 T cells.
  • CNP-104 was safe and well-tolerated, with all drug-related adverse events reported as mild during the 120-day primary study period.
  • These results suggest CNP-104 has the potential to halt disease progression, offering a transformational advancement for PBC treatment.

Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects with Primary Biliary Cholangitis

NCT05104853Active, Not RecruitingPhase 1
COUR Pharmaceutical Development Company, Inc.
Posted 1/25/2022

Semaglutide Use Surges Among Gen X, Impacting Aesthetics Market

  • Semaglutide usage has surged due to FDA approval for weight loss management, providing a regulated avenue for prescription.
  • Gen X (born 1965-1980) comprises the largest group of semaglutide patients (44%) due to higher disposable income and health concerns.
  • Semaglutide adoption is driving new patients to aesthetics practices, with potential shifts in spending across different aesthetic treatments.
  • Physicians should address physical changes during semaglutide treatment, like sagging facial skin, which may necessitate additional aesthetic interventions.

ASCO 2024: Experts Debate Neoadjuvant Therapy vs. Surgery in NSCLC

  • A debate at ASCO 2024 explored the evolving treatment landscape for non-small cell lung cancer (NSCLC), focusing on neoadjuvant therapy versus surgery.
  • The CROWN trial data highlighted lorlatinib's significant progression-free survival benefit over crizotinib in ALK-positive NSCLC, sparking discussion on sequencing TKI therapies.
  • CHRYSALIS-2 trial results showcased the potential of amivantamab plus lazertinib in EGFR-mutated NSCLC, though administration challenges were acknowledged.
  • Experts debated the role of neoadjuvant therapy, with arguments presented for its superiority in certain NSCLC cases based on improved outcomes and tailored treatment approaches.

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

NCT02998528CompletedPhase 3
Bristol-Myers Squibb
Posted 3/4/2017

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

NCT04077463Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/4/2019

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

NCT03052608Active, Not RecruitingPhase 3
Pfizer
Posted 4/27/2017

Progesterone Drug Provera Linked to Vision Loss in Meningioma Patients

  • A recent study identifies progesterone, specifically Provera, as a significant risk factor for vision loss related to meningiomas in premenopausal women.
  • Researchers are now conducting tests on patient samples to determine the prevalence of progesterone receptor expression in meningiomas.
  • The study emphasizes the importance of age-appropriate counseling and consistent assessment of hormone receptor status in meningiomas.
  • Clinicians have begun informing patients about the risks associated with Provera, leading many to discontinue its use.

ctDNA-Based Platform Aims to Accelerate Cancer Drug Development

  • A new platform leverages circulating tumor DNA (ctDNA) to detect recurrence, potentially accelerating cancer drug development and reducing costs.
  • ctDNA monitoring can identify molecular evidence of disease recurrence earlier than traditional methods, allowing for earlier therapeutic intervention.
  • The platform aims to improve the efficiency of clinical trials by enriching for patients with molecular residual disease (MRD).
  • The FDA supports the use of ctDNA in early-stage solid tumor drug development, highlighting the urgent need for MRD-based trials.

A Trial Using ctDNA Blood Tests to Detect Cancer Cells After Standard Treatment to Trigger Additional Treatment in Early Stage Triple Negative Breast Cancer Patients

NCT03145961Unknown StatusPhase 2
Institute of Cancer Research, United Kingdom
Posted 12/21/2017

Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection

NCT04457297RecruitingPhase 3
National Cancer Center Hospital East
Posted 7/8/2020

Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

NCT04642469CompletedPhase 3
AstraZeneca
Posted 11/30/2020

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

NCT04660344Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2021

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

NCT04915755Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 6/28/2021

Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation

NCT04089631RecruitingPhase 3
Technische Universität Dresden
Posted 6/26/2020

CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer

NCT03285412RecruitingPhase 2
Massachusetts General Hospital
Posted 12/12/2017

Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery

NCT04068103Active, Not RecruitingPhase 2
NRG Oncology
Posted 12/16/2019

Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors

NCT03832569Active, Not RecruitingEarly Phase 1
Memorial Sloan Kettering Cancer Center
Posted 2/20/2019

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

NCT05987241RecruitingPhase 2
National Cancer Institute (NCI)
Posted 2/2/2024

Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)

NCT04585477RecruitingPhase 2
Stanford University
Posted 4/8/2021

Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select Stage III [Any T1-3 N1-2 and T4N0-2] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA)

NCT04367311RecruitingPhase 2
Nasser Hanna
Posted 5/22/2020

Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)

NCT04434040Active, Not RecruitingPhase 2
Dana-Farber Cancer Institute
Posted 7/2/2020

Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

NCT03803553RecruitingPhase 3
Massachusetts General Hospital
Posted 4/16/2020

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

NCT05174169RecruitingPhase 2
NRG Oncology
Posted 3/10/2022

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

NCT05512364RecruitingPhase 3
European Organisation for Research and Treatment of Cancer - EORTC
Posted 12/15/2023

CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II

NCT04120701RecruitingPhase 3
Centre Hospitalier Universitaire Dijon
Posted 1/17/2020

Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer

NCT04050345Recruiting
Royal Marsden NHS Foundation Trust
Posted 12/5/2016

A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection

NCT04510285TerminatedPhase 2
Memorial Sloan Kettering Cancer Center
Posted 8/10/2020

A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer

NCT04985266RecruitingPhase 2
Royal Marsden NHS Foundation Trust
Posted 3/30/2022

Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC

NCT04585490RecruitingPhase 3
Maximilian Diehn
Posted 8/25/2021

Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)

NCT04385368CompletedPhase 3
AstraZeneca
Posted 7/17/2020

DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)

NCT04567420RecruitingPhase 2
Criterium, Inc.
Posted 2/9/2021

Arcturus/CSL COVID-19 Vaccine Shows Enhanced, Durable Immune Response Compared to Comirnaty

• Arcturus Therapeutics and CSL's self-amplifying mRNA vaccine, ARCT-154, demonstrates superior immune responses compared to BioNTech/Pfizer's Comirnaty vaccine after 12 months. • The Phase III trial in Japan showed ARCT-154 elicited significantly more neutralizing antibodies against various SARS-CoV-2 strains than Comirnaty at the 12-month mark. • Arcturus' self-amplifying mRNA technology allows for quick and long-lasting antigen expression, potentially providing more durable protection against COVID-19 with lower doses. • Arcturus and CSL are also developing a bivalent vaccine, ARCT-2301, which early research suggests has better immunogenicity than the bivalent version of Comirnaty.

Tenax Therapeutics' Levosimendan Shows Promise in Pulmonary Hypertension with Heart Failure

  • Tenax Therapeutics is developing levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), a condition affecting over 2 million U.S. patients.
  • Phase II HELP trial data indicated levosimendan prevented increased stress blood volume during exertion, significantly improving six-minute walk distance.
  • The company is currently enrolling patients in the Phase III LEVEL trial, with results expected in the second half of 2025, potentially de-risking the program.
  • Levosimendan has demonstrated unique properties including inotropic support and vasodilation across multiple heart failure indications.

Cell and Gene Therapies Emerge as Promising Avenues for Alzheimer's Disease Treatment

• Several cell and gene therapies are under investigation for Alzheimer's disease, with some showing early signs of efficacy in clinical trials. • NKGen's SNK01, an autologous NK cell therapy, demonstrated encouraging clinical activity and tolerability in a Phase 1 trial, with improvements in ADCOMS scores and CSF α-syn levels. • Longeveron's Lomecel-B, an allogeneic MSC therapy, showed statistically significant improvements in ADCS-ADL scores and trends of improvement on MMSE in a Phase 2 trial. • Beyond amyloid-targeting antibodies, researchers are exploring diverse targets like tau, inflammation, and viral proteins, with drug repurposing strategies also gaining traction.

Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD)

NCT04678453TerminatedPhase 1
NKGen Biotech, Inc.
Posted 1/6/2021

Lomecel-B Effects on Alzheimer's Disease

NCT05233774CompletedPhase 2
Longeveron Inc.
Posted 12/28/2021

A Clinical Trial of AAV2-BDNF Gene Therapy in Early Alzheimer's Disease and Mild Cognitive Impairment

NCT05040217RecruitingPhase 1
Mark Tuszynski
Posted 2/7/2022

Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease

NCT05667649RecruitingPhase 1
Regeneration Biomedical, Inc.
Posted 8/14/2023

Zydus Life Receives US FDA Approval for Enzalutamide Capsules in Prostate Cancer Treatment

  • Zydus Lifesciences secures US FDA approval for Enzalutamide capsules, a key medication in treating metastatic castration-resistant prostate cancer.
  • The approved drug, with an estimated annual sales of $869.4 million in the US, will be manufactured at Zydus' facility in Moraiya, Ahmedabad.
  • Enzalutamide is projected to be a major player in the prostate cancer treatment market, with combined sales of similar agents expected to reach $14.2 billion by 2029.
  • Zydus Life shares have shown significant growth, increasing by 76% over the past year, reflecting strong investor confidence and market performance.

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