Clinical Trials - Phase II
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BeyondSpring Announces First Patient Dosed with Pembrolizumab, Plinabulin Plus Etoposide/Platinum in a Phase 2 Investigator-initiated Study of First-Line Extensive-Stage Small-Cell Lung Cancer
3/25/2024
BeyondSpring Inc. today announced that the first patient has been dosed in a Phase 2 investigator-initiated trial (IIT) with Pembrolizumab, Plinabulin.
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Chemomab Awarded New European Patent for CM-101, Its First-in Class Monoclonal Antibody in Phase 2 Clinical Development for Primary Sclerosing Cholangitis
3/25/2024
Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab) today reported that the European Patent Office has granted a new patent for CM-101, Chemomab’s first-in-class monoclonal antibody that neutralizes CCL24, a novel disease target that has been shown to play a critical role in the processes that drive fibrosis and inflammation.
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Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection
3/25/2024
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
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Bio-Thera Solutions Receives IND Clearance From US FDA to Initiate a Phase II Study for BAT8006, an Innovative Antibody Drug Conjugate Targeting Folate Receptor α
3/25/2024
Bio-Thera Solutions today announced receiving IND clearance from the US FDA for a phase II Study for BAT8006, an innovative Antibody Drug Conjugate (ADC) targeting Folate Receptor α (FRα).
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Stoke Therapeutics Announces Landmark New Data That Support the Potential for STK-001 to be the First Disease-Modifying Medicine for the Treatment of Patients with Dravet Syndrome
3/25/2024
Stoke Therapeutics, Inc. (Nasdaq: STOK) today announced landmark new data from two open-label Phase 1/2a studies and two open-label extension (OLE) studies of children and adolescents ages 2 to 18 with Dravet syndrome who were treated with STK-001.
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Astria Therapeutics Announces Positive Initial Proof-of-Concept Results from the ALPHA-STAR Phase 1b/2 Trial of STAR-0215 for HAE
3/25/2024
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, today announced positive initial proof-of-concept results from the ALPHA-STAR Phase 1b/2 clinical trial evaluating STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients.
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ProLynx announces initiation of the Phase II Topology clinical trial of its DNA-damaging agent PLX038 in triple-negative breast cancer at the Institut Curie
3/25/2024
ProLynx Inc. announced that the first patient was included in TOPOLOGY by investigator Dr. Delphine Loirat, with a Phase II clinical trial investigating PLX038 (PEG~SN-38) for locally-advanced or metastatic triple-negative breast cancer (TNBC).
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Andelyn Biosciences and Grace Science, LLC Partner to Tech Transfer Phase I/II/III Manufacturing of a Suspension Process Adeno-Associated Virus (AAV) Gene Therapy for NGLY1 Deficiency
3/25/2024
Andelyn Biosciences has partnered with Grace Science, LLC, to tech transfer and manufacture GS-100, a suspension process AAV NGLY1 gene therapy for Phase I/II/III clinical trial material for the treatment of NGLY1 Deficiency.
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NMD Pharma Receives FDA IND Clearance to initiate a Phase 2b Clinical Trial of NMD670 in Generalized Myasthenia Gravis Patients in the US
3/22/2024
NMD Pharma A/S today announces that it has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 2b clinical trial of NMD670 in patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
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IRLAB Receives Minutes From End-of-Phase 2 Meeting Confirming Alignment with the FDA on the Phase III Program For Mesdopetam
3/22/2024
IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) IRLAB Therapeutics AB (Nasdaq Stockholm:IRLAB A), a company discovering and developing novel treatments for Parkinson's disease, today announced the receipt of written minutes from a recent End-of-Phase 2 meeting for mesdopetam with the US Food and Drug Administration, FDA.
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First patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis
3/22/2024
Molecure S.A. has started the clinical trial where OATD-01 is being administered to patients with active pulmonary sarcoidosis as part of a Phase II clinical trial.
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OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Multiple Signs and Symptoms of Dry Eye Disease including Ocular Pain Relief in its First-in-Human Phase 2 Trial of OK-101
3/22/2024
OKYO Pharma Limited announced today additional key findings from analyses of the clinical data set from the 240 patient Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with DED.
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HUTCHMED Initiates Registration Stage of the ESLIM-02 Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China
3/21/2024
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China.
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Blue Lake Biotechnology Reports Positive Interim Clinical Data in Children for Its RSV Vaccine Candidate
3/21/2024
Blue Lake Biotechnology, Inc. today announced preliminary data from the first two cohorts of a Phase 1/2a clinical trial studying BLB201, the company’s investigational vaccine against severe respiratory syncytial virus (RSV) disease.
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Bionomics Reports Results of the Full Dataset Analysis from ATTUNE Phase 2b Trial of BNC210 in Patients with Post-Traumatic Stress Disorder
3/21/2024
Bionomics Limited announced the release of the full dataset analysis from its Phase 2b ATTUNE trial in patients with post-traumatic stress disorder.
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Antengene Initiates Phase II Dose Expansion Study of Claudin 18.2 ADC ATG-022 in China and Australia
3/20/2024
Antengene Corporation Limited today announced that it has initiated the dose expansion portion of the Phase II CLINCH study of ATG-022 (Claudin 18.2 antibody-drug conjugate[ADC]) in China and Australia.
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IGC Pharma Announces Positive Interim Results for IGC-AD1 in Reducing Alzheimer’s Agitation
3/20/2024
IGC Pharma, Inc. (“IGC Pharma”, “IGC”, or the “Company”) (NYSE American: IGC) today announced the results of an interim analysis of its ongoing Phase 2 trial investigating IGC-AD1 as a treatment for Agitation in dementia from Alzheimer’s Disease (“AAD”).
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BerGenBio Announces Initiation of Phase 2a in First Line Non-Small Lung Cancer Patients with a STK11 mutation
3/20/2024
BerGenBio ASA (OSE: BGBIO) announced today it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m).
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ACELYRIN, INC. Announces Positive Phase 1/2 Proof-of-Concept Data for Lonigutamab, First Subcutaneous Anti-IGF-1R to Demonstrate Clinical Responses in Thyroid Eye Disease
3/20/2024
ACELYRIN, INC today announced positive proof-of-concept data from an ongoing Phase 1/2 trial of lonigutamab in thyroid eye disease (TED). Lonigutamab is a subcutaneously (SC) delivered humanized IgG1 monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), a validated mechanism of action for the treatment for TED.
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Celularity Submits Request to U.S. FDA for Orphan Drug Designation for PDA-002 Asset Treating Facioscapulohumeral Muscular Dystrophy
3/20/2024
Celularity Inc., a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced that it has submitted a request to the U.S. Food and Drug Administration for orphan drug designation for its off-the-shelf, placental-derived cell therapy, PDA-002, for treating Facioscapulohumeral Muscular Dystrophy.