Clinical Trials - Phase II
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LIXTE Biotechnology Reports First Spanish Site Activated to Begin Accrual of Patients for a Phase 1b/2 Clinical Trial of LIXTE's Lead Anti-Cancer Compound, LB-100, Added to Doxorubicin as First-Line Treatment of Advanced Soft Tissue Sarcoma
4/24/2023
LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”) announced that the Spanish Sarcoma Research Group (Grupo Español de Investigación en Sarcomas, or GEIS) completed its first site initiation visit in preparation for the advanced soft tissue sarcoma (ASTS) clinical trial at Fundación Jiménez Díaz University Hospital (Madrid).
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Morphic Therapeutic to Host EMERALD-1 Topline Results Call on April 25, 2023
4/24/2023
Morphic Therapeutic announced it will host a webcast and conference call to discuss topline results from the main cohort of the open-label EMERALD-1 Phase 2a study of MORF-057 in adults with moderate to severe ulcerative colitis.
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Baudax Bio to Host Key Opinion Leader Webinar to Discuss Results of Phase 2 BX1000 TrialVirtual Webinar to be held April 25, 2023 at 10:00 AM Eastern Time
4/24/2023
Baudax Bio, Inc. announced the Company is hosting a virtual key opinion leader event Innovation in Anesthesia: BX1000 for Neuromuscular Blockade featuring Dr. Todd M. Bertoch, Chief Executive Officer of JBR Clinical Research, and Dr. Harold S. Minkowitz, Associate Director for Clinical Research at The University of Texas MD Anderson Cancer Center Department of Anesthesiology and Perioperative Medicine.
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IDEAYA Announces Positive Interim Phase 2 Data for Darovasertib and Crizotinib Combination and Successful FDA Type C Meeting on Registrational Trial Design for Accelerated Approval in First-Line Metastatic Uveal Melanoma
4/23/2023
IDEAYA Biosciences, Inc. announced further interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib combination in metastatic uveal melanoma patients.
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Lexicon To Present Results From LX9211 Phase 2 Trial In Postherpetic Neuralgia At The 2023 American Academy Of Neurology (AAN) Annual Meeting And The British Pain Society (BPS) 56th Annual Scientific Meeting 2023
4/21/2023
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that results from RELIEF-PHN-1, a Phase 2 double-blind, placebo-controlled trial of its investigational drug LX9211 for the treatment of postherpetic neuralgia, will be presented during the Emerging Science session at the AAN Annual Meeting, April 22-27, in Boston, MA.
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Cantex and Michigan Medicine Announce Initiation of a Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Clinical Study to Determine the Safety and Efficacy of Azeliragon in the Treatment of Patients Hospitalized for COVID-19
4/20/2023
Cantex Pharmaceuticals, Inc. and Michigan Medicine, a part of the University of Michigan and one of the nation's leading academic medical centers, announced today the initiation of a randomized double-blind, placebo-controlled, multicenter, phase 2/3 clinical study to evaluate the safety and efficacy of azeliragon in decreasing the incidence of acute kidney injury and other life-threatening complications in patients hospitalized for COVID-19.
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Apex Labs Granted Approval for 160 Patient Macrodose Multi-Dose Psilocybin Clinical Trial by Health Canada
4/20/2023
Apex Labs Ltd. is pleased to announce approval of SUMMIT-90. SUMMIT-90 is a landmark double-blind, placebo controlled phase 2b study evaluating multiple doses of APEX-90 administered in-clinic with assisted psychotherapy for the treatment of severe depression within diagnosed PTSD.
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MAIA Biotechnology Reports Preliminary Survival Data in Part A of THIO-101 Phase 2 Trial for Non-Small Cell Lung Cancer
4/20/2023
MAIA Biotechnology, Inc. (NYSE American: MAIA ) today announced preliminary survival data in the Part A safety lead-in of its ongoing phase 2 trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC).
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Sensei Biotherapeutics Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for SNS-101, a Conditionally Active VISTA-Blocking Antibody
4/20/2023
Sensei Biotherapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SNS-101, a conditionally active VISTA-blocking antibody, paving the way for the Company to conduct a Phase 1/2 clinical trial in patients with solid tumors.
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Achieve Life Sciences Announces Positive Phase 2 ORCA-V1 Trial Results Showing Statistically Significant Vaping Cessation Benefit for Participants Treated with Cytisinicline
4/20/2023
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today reported positive topline results from its Phase 2 ORCA-V1 trial.
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Dermata Announces Receipt of Type C Meeting Response from the FDA and Submission of DMT310 End of Phase 2 Meeting Package
4/20/2023
Dermata Therapeutics, Inc. announced that it has received a response from the U.S. Food and Drug Administration to the Company's Type C Chemistry, Manufacturing, and Controls meeting request.
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Promore Pharma Reports Outcome from Clinical Phase II Study with Ensereptide
4/20/2023
Promore Pharma AB announces that the results from the company's Phase II study PHSU05 with ensereptide in prevention of skin scarring have been concluded.
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BioInvent Announces a Fourth Complete Response in Phase 1/2 Trial with BI-1206 in Non-Hodgkin’s Lymphoma
4/20/2023
BioInvent International AB announces that a fourth complete response has been observed in the 100 mg dose expansion cohort in the IV arm of the Phase 1/2 trial of its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, in combination with rituximab in non-Hodgkin's lymphoma.
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Innovent Announces Overall Survival Results of Phase 2 Study of Pemazyre® (pemigatinib) in Chinese Patients with Advanced Cholangiocarcinoma Presented at AACR Annual Meeting 2023
4/20/2023
Innovent Biologics, Inc., announced that the overall survival results of the Phase 2 study of pemigatinib in Chinese patients with advanced cholangiocarcinoma were presented at the American Association for Cancer Research Annual Meeting 2023.
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Luxa Biotechnology to Provide Update on Clinical Trial of Retinal Pigmented Epithelium Stem Cell (RPESC) Technology for Treatment of Dry Age-Related Macular Degeneration in Panel Session at ARVO 2023
4/20/2023
Luxa Biotechnology today announced the company will provide an update on the progress of a Phase 1/2a clinical trial evaluating transplantation of RPESC-RPE-4W to treat dry age-related macular degeneration (AMD) at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held in New Orleans from April 23– 27, 2023.
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Myrtelle Announces Positive 6-month Post-Treatment Data in Patients in Its First-in-Human Clinical Study of rAAV-Olig001-ASPA Gene Therapy in Canavan Disease
4/19/2023
Analyses at 6 months showed increases in myelin, white matter and other MRI and MRS measurements as well as functional improvements on validated assessment scales.
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Plus Therapeutics Completes Enrollment of the Original Three Patients Required for Cohort 8 of ReSPECT-GBM Phase 1/2a Trial
4/19/2023
Plus Therapeutics, Inc. today announced the completion of enrollment of the original three patients required in Cohort 8 of the ReSPECT-GBM Phase 1/2a dose escalation clinical trial of rhenium ( 186 Re) obisbemeda for the treatment of recurrent glioblastoma (GBM).
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ANNOVIS BIO ANNOUNCES UPDATE ON RECRUITMENT INTO ITS PHASE 2/3 ALZHEIMER'S STUDY AND UPCOMING R&D WEBCAST
4/19/2023
Annovis Bio, Inc. today announced that patient recruitment for the Company's Phase 2/3 study of buntanetap for the treatment of moderate Alzheimer's disease (AD) remains consistent with its planned development program.
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Zucara Therapeutics Receives IND Clearance for Phase 2 Clinical Trial of ZT-01
4/19/2023
Zucara Therapeutics Inc., today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug ("IND") application for ZT-01 for the prevention of night-time (nocturnal) hypoglycemia in patients with Type 1 Diabetes ("T1D").
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Longeveron Announces First Patient Dosed in Phase 2 Clinical Trial of Lomecel-B™ for Aging-Related Frailty in Japan
4/19/2023
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced that the first patient has been treated with Lomecel-B™ in its Phase 2 clinical trial in patients with Aging-Related Frailty in Japan.