Clinical Trials - Phase II
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On the heels of withdrawing Relyvrio from the U.S. and Canadian markets, Amylyx is now charting a path in Wolfram syndrome with promising interim Phase II data for its lead asset AMX0035.
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Possible New Hope for Metastatic Cancer Patients: Food and Drug Administration Grants Approval for Clinical Trials For Lamassu's Groundbreaking Cancer Treatment Protocol
4/11/2024
Lamassu Biotech is proud to announce its pioneering effort to combat locally advanced metastatic p53 wild-type tumors has earned investigational new drug application (IND) approval from the Food and Drug Administration (FDA) to proceed in initiate Phase 1/2a clinical trials.
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Enlivex Announces Topline Results of Its Phase II Trial Evaluating Allocetra™ In Patients With Sepsis
4/11/2024
Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive indication of effect and safety results from its Phase II study of Allocetra™ in patients with sepsis, in which 120 patients enrolled.
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Algiax Pharmaceuticals Expands Phase 2a Study with Lead Candidate AP-325 in Chronic Neuropathic Pain with 12 New Clinical Sites in Belgium and France
4/11/2024
Algiax Pharmaceuticals, provided an update on its ongoing Phase 2a study with lead candidate AP-325 in patients with chronic neuropathic pain.
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Boundless Bio Announces First Patient Dosed in First-in-Human Phase 1/2 Clinical Trial of BBI-825 in Cancer Patients with Resistance Gene Amplifications
4/11/2024
Boundless Bio today announced that the first patient has been dosed with BBI-825 in a first-in-human, Phase 1/2 clinical trial for patients with locally advanced or metastatic cancer with resistance gene amplifications (NCT06299761).
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Allay Therapeutics’ Phase 2B Clinical Study Supports Ability of ATX101 To Deliver Four Weeks of Sustained Post-surgical Pain Relief
4/11/2024
Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, announced the results from a Phase 2B clinical study of its lead investigational product ATX101.
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Merck and Kelun-Biotech’s antibody-drug conjugate achieved a 22% objective response rate and 80.5% disease control rate in heavily pretreated patients with gastric or gastroesophageal junction cancer.
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Amylyx Pharmaceuticals Announces Interim Data From Ongoing Phase 2 HELIOS Clinical Trial Demonstrating Improvements in Pancreatic Function and Glycemic Control with AMX0035 in People with Wolfram Syndrome
4/10/2024
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced interim data from the ongoing Phase 2 HELIOS clinical trial of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults living with Wolfram syndrome, a rare, progressive genetic disease impacting approximately 3,000 people in the U.S.
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Medicenna Presents Updated Results of Single Agent MDNA11 Anti-tumor Activity from Dose Escalation and Ongoing Dose Expansion of the Phase 1/2 ABILITY-1 Study
4/10/2024
Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA), a clinical-stage immunotherapy company focused on the development of Superkines, presented updated clinical results from the monotherapy dose escalation and ongoing expansion portions of the Phase 1/2 ABILITY-1 (ABeta-only IL-2 ImmunoTherapY) study.
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Gabather Joins Forces with the Centre for Neuropsychiatric Schizophrenia Research in Denmark to Conduct a Clinical Phase II Study with GT-002
4/10/2024
Gabather AB (Nasdaq First North Growth Market: GABA) announces that the Company has signed a Collaborative Agreement with the Centre for Neuropsychiatric Schizophrenia Research at the Psychiatric Centre in Glostrup to conduct a so-called clinical phase II study with GT-002 in patients diagnosed with schizophrenia.
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EpiEndo reports Phase 2A results for lead asset, EP395, in COPD
4/10/2024
EpiEndo Pharmaceuticals announces the successful completion of its Phase 2A clinical trial for EP395 in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
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RAPT Therapeutics Announces Promising Results from Phase 2 Trial of Tivumecirnon in Combination with Anti-PD-1 Immunotherapy in CPI-Experienced Head and Neck Cancer Patients
4/9/2024
RAPT Therapeutics, Inc. (Nasdaq: RAPT) today announced safety and efficacy data from its ongoing Phase 2 trial of tivumecirnon in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab in the cohort of patients with advanced head and neck squamous cell carcinoma (HNSCC) whose disease progressed despite previous treatment with CPI therapy (CPI-experienced).
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Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by MASH
4/9/2024
Galectin Therapeutics, Inc. reported the positive outcome of its fifth independent data and safety monitoring board meeting for NAVIGATE, its seamless, adaptive, Phase 2b/3 study of belapectin in patients with cirrhotic portal hypertension caused by Metabolic Dysfunction-Associated SteatoHepatitis.
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ALX Oncology Reports Encouraging Clinical Data of Evorpacept in Combination with Standard-of-Care in an Ongoing Phase 1/2 Clinical Trial in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (“R/R B-NHL”)
4/9/2024
ALX Oncology Holdings Inc. reported encouraging clinical data from the ongoing Phase 1/2 investigator-sponsored trial of evorpacept in combination with R2 in patients with indolent and aggressive R/R B-NHL.
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Medicenna Presents Updated Results of Single Agent MDNA11 Anti-tumor Activity from Dose Escalation and Ongoing Dose Expansion of the Phase 1/2 ABILITY-1 Study at the 2024 Annual Meeting of the American Association for Cancer Research (AACR)
4/9/2024
Medicenna Therapeutics Corp. presented updated clinical results from the monotherapy dose escalation and ongoing expansion portions of the Phase 1/2 ABILITY-1 study evaluating MDNA11, a long-acting ‘beta-enhanced not-alpha’ interleukin-2 super-agonist, in patients with advanced solid tumors, at the 2024 Annual Meeting of the American Association for Cancer Research held in San Diego, CA, on April 9th, 2024.
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Notable Labs Presents the Design Plan for the PPMP-Enabled Phase 2 Trial with Volasertib for Relapsed/Refractory AML at AACR 2024
4/9/2024
Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable” or the “Company”) today presented the design for the PPMP-enabled Phase 2 trial with volasertib, in combination with decitabine, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR 2024) being held in San Diego, CA (Poster abstract 5178).
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Fusion Pharmaceuticals Announces Presentation of Interim Data from the Phase 2 TATCIST Clinical Trial Evaluating FPI-2265 at the AACR Annual Meeting 2024
4/9/2024
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) today announced the presentation of interim efficacy and safety data from the Phase 2 TATCIST open-label clinical trial evaluating FPI-2265, at the American Association for Cancer Research (AACR) Annual Meeting 2024 being held April 5-10 in San Diego, California.
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Novo Nordisk and Ionis Pharmaceuticals unveiled promising respective data at the American College of Cardiology’s Annual Scientific Session, while Boehringer Ingelheim and Eli Lilly’s Jardiance missed the endpoint in a myocardial infarction study.
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IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm® in Phase 2 ‘MONTPARK’ Clinical Trial
4/8/2024
IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.
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KRAZATI (adagrasib) in Combination with Cetuximab Demonstrates Clinically Meaningful Activity as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)
4/8/2024
Bristol Myers Squibb (NYSE: BMY) today announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).