Clinical Trials - Phase III
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Innovent Releases Final Analysis Results of ORIENT-16: the Phase 3 Study of Sintilimab in Combination with Chemotherapy for the First-Line Treatment of Gastric Cancer at the AACR Annual Meeting 2023
4/18/2023
Innovent Biologics, Inc. announced the final analysis results of ORIENT-16, the Phase 3 study evaluating sintilimab in combination with chemotherapy compared to chemotherapy for the first-line treatment of advanced or metastatic gastric or gastroesophageal junction cancer at the American Association for Cancer Research Annual Meeting 2023.
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Spexis announces closing of capital commitment of USD 4.5 million from SPRIM Global Investments (SGI) to enable initiation of ColiFin® Phase 3 study
4/18/2023
Spexis AG announced that the company has finalized a capital commitment from SPRIM Global Investments totaling USD 4.5 million in the form of secured, interest-bearing debt with partial warrant coverage and subordinated debt mandatorily converting into equity.
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Awakn Life Sciences Signs Collaboration Agreement with University of Exeter for Upcoming Phase III Trial
4/18/2023
Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD)
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Alzheon to Present Baseline Imaging Characteristics from Ongoing APOLLOE4 Phase 3 Trial of Oral Tablet ALZ-801 (Valiltramiprosate) and Results of Phase 2 Biomarker Study at American Academy of Neurology Conference in Boston
4/18/2023
Alzheon, Inc. announced that it will be presenting baseline imaging characteristics from ongoing APOLLOE4 Phase 3 clinical trial and 12-month results from the Phase 2 biomarker study evaluating ALZ-801 oral tablet at the upcoming American Academy of Neurology Conference to be held from April 22 – April 27, 2023 in Boston, Massachusetts.
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Top 2023 Neurodegenerative Readouts
4/17/2023
Clinical results for experimental treatments in Alzheimer’s, ALS and more are expected over the coming months. BioSpace highlights a few of the more highly anticipated datasets. -
Between new formulations of traditional drugs nearing the market and completely novel approaches in mid-stage trials, 2023 is poised to be a pivotal year in Parkinson’s disease treatment.
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AffaMed Therapeutics Announces Approval to Initiate a Phase 3 Registrational Clinical Trial in Mainland China for DEXTENZA® for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery
4/17/2023
AffaMed Therapeutics ("AffaMed") today announced that China's National Medical Products Administration (NMPA) has approved AffaMed's Clinical Trial Application (CTA) to initiate a Phase 3 registrational study in China to investigate the efficacy and safety of DEXTENZA in subjects following ophthalmic surgery.
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BioLineRx Announces Publication in Nature Medicine of its GENESIS Phase 3 Clinical Trial Data Evaluating Motixafortide and G-CSF in Stem Cell Mobilization for Autologous Transplantation in Multiple Myeloma
4/17/2023
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced the publication of data from the Company's GENESIS Phase 3 clinical trial in the peer-reviewed journal Nature Medicine.
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Innovent Releases Final Analysis Results of ORIENT-15: the Phase 3 Study of Sintilimab plus Chemotherapy for the First-Line Treatment of Esophageal Squamous Cell Carcinoma at the AACR Annual Meeting 2023
4/17/2023
Innovent Biologics, Inc. announced that the final analysis results of ORIENT-15, the Phase 3 study evaluating sintilimab in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma were released in a poster presentation at the American Association for Cancer Research Annual Meeting 2023.
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Genentech’s Tecentriq Plus Avastin Reduced the Risk of Cancer Returning in People With Certain Types of Adjuvant Liver Cancer in a Phase III Study
4/16/2023
Genentech, a member of the Roche Group, announced new data from the Phase III IMbrave050 study that show Tecentriq® plus Avastin® demonstrated a statistically significant improvement in recurrence-free survival in people with hepatocellular carcinoma at high risk of disease recurrence following liver resection or ablation with curative intent.
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IMFINZI-based treatment before and after surgery reduced the risk of disease recurrence, progression events or death by 32% in resectable non-small cell lung cancer in the AEGEAN Phase III trial
4/16/2023
Positive results from the AEGEAN Phase III trial showed that treatment with AstraZeneca’s IMFINZI® in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery led to a statistically significant and clinically meaningful improvement in event-free survival versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage non-small cell lung cancer.
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The regulator found no issues with mirikizumab's clinical or safety data.
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Results from Astellas' Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet
4/14/2023
Astellas Pharma Inc. announced that The Lancet published detailed data from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin 18.2 targeted monoclonal antibody, plus mFOLFOX6 versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
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Minghui Pharmaceutical Inc. Announces Phase 2 Clinical Trial Success of MH004 Cream as a Potential Best-in-Class Topical Treatment for Mild-to-Moderate Atopic Dermatitis and the FDA Clearance of its Global Phase 3 MRCT
4/14/2023
Minghui Pharmaceutical, Inc. today announced positive top line results from its Phase 2 study evaluating MH004 Cream, the topical cream of a pan-JAK inhibitor, for treatment of adolescents and adults with mild-to-moderate atopic dermatitis (AD).
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RenovoRx Presenting Phase III Clinical Trial Interim Analysis Data of the TIGeR-PaC Study at American Association for Cancer Research Annual Meeting Underway in Orlando, Florida
4/14/2023
RenovoRx Presenting Phase III Clinical Trial Interim Analysis Data of the TIGeR-PaC Study at American Association for Cancer Research Annual Meeting Underway in Orlando, Florida.
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Liver toxicities triggered a partial clinical hold on Merck KGaA's trial studying its BTK inhibitor candidate for multiple sclerosis.
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Tonix Pharmaceuticals Expedites Fibromyalgia and Chronic Migraine Programs
4/13/2023
Tonix Pharmaceuticals Holding Corp. today announced that it is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for chronic migraine.
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Aldeyra Therapeutics Completes Enrollment in Phase 3 INVIGORATE-2 Clinical Trial in Allergic Conjunctivitis
4/13/2023
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced completion of enrollment in the Phase 3 INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis.
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First Patient Enrolled into U.S. Phase 3 Neurotrophic Keratitis Clinical Trial with RGN-259
4/13/2023
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, has announced that on April 12, the first patient of the Phase 3 clinical trial (SEER-2) of RGN-259, a novel treatment for neurotrophic keratitis (NK), has been enrolled and begun treatment.
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Interim Analysis of the Phase 3 PROTECT Study of FILSPARI™ (Sparsentan) in IgA Nephropathy Presented by Travere Therapeutics at NKF Spring Clinical Meetings
4/13/2023
The National Kidney Foundation (NKF) will feature a late-breaking plenary session by Travere Therapeutics on the interim analysis of efficacy and safety data from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ (Sparsentan) in adults with IgA nephropathy (IgAN).