News & Updates

Freedom Biosciences Announces FDA Approval of IND Application for FREE001 in Patients with Treatment-Resistant Depression


Excerpt from the Press Release: SAN FRANCISCO, April 25, 2024 /PRNewswire/ — Freedom Biosciences, Inc. (“Freedom Bio” or the “Company”), a clinical-stage biotechnology platform focused on developing next-generation neuropsychiatric therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with its FREE001-TRD-201 study for its lead program, FREE001,…

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Join The TrialStat Team at the Precision in Clinical Trials Summit in Boston, May 6-7th

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Aspen Neuroscience Announces First Patient Dosed in First-in-Human Phase 1/2a Clinical Trial of Autologous Neuronal Cell Replacement Therapy for Parkinson’s Disease


Excerpt from the Press Release: First U.S. Multi-center, Multi-patient Phase 1/2a Trial of an Autologous Neurological Therapy SAN DIEGO, April 17, 2024 /PRNewswire/ — Aspen Neuroscience, Inc. announced that the first patient has been dosed in the ASPIRO trial, a Phase 1/2a open label clinical trial to assess safety and tolerability of ANPD001, an autologous, dopaminergic neuron…

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Benitec Biopharma Reports Positive Interim Clinical Trial Data for First OPMD Subject Treated with BB-301 in Phase 1b/2a Study


-First efficacy signals demonstrated for a gene therapy under development for Oculopharyngeal Muscular Dystrophy (OPMD) which affects ~15,000 patients worldwide- – BB-301 facilitated improvements across multiple measures of swallowing function in the first Phase 1b/2a clinical study subject as compared to pretreatment assessments conducted during the observational natural history portion of the study- Excerpt from…

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D2M Biotherapeutics Announces First Patient Dosed in A Phase 1 Study Evaluating DM919, a Novel MICA/B Antibody for Treating Patients with Advanced Solid Tumors


Excerpt from the Press Release: In the news release, D2M Biotherapeutics Announces First Patient Dosed in A Phase 1 Study … issued 18-Apr-2024 by D2M Biotherapeutics, Inc. over PR Newswire, the headline was incorrectly separated by PR Newswire into two parts. The corrected release (with headline intact) follows: D2M Biotherapeutics Announces First Patient Dosed in…

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Oncternal Announces First Patient Dosed in Fourth Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer


Excerpt from the Press Release: SAN DIEGO, April 18, 2024 (GLOBE NEWSWIRE) — Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the first patient has been dosed in the fourth cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients…

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Cerevel Therapeutics Announces Positive Topline Results for Tavapadon in Phase 3 Adjunctive Trial for People Living with Parkinson’s Disease


Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-3 adjunctive trial, demonstrating a statistically significant increase in total “on” time without troublesome dyskinesia compared with placebo over 27 weeks Results demonstrate tavapadon’s potential to provide the right balance of motor control, safety and tolerability for people living with Parkinson’s disease Additional data from…

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Nutcracker Therapeutics Demonstrates Enhanced Functional Activity of Prostate Cancer Candidate NTX-470 at the 2024 AACR Annual Meeting


Excerpt from the Press Release: EMERYVILLE, Calif.–(BUSINESS WIRE)–Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, recently presented two posters at the American Association for Cancer Research (AACR) Annual Meeting in San Diego: one showcasing the latest preclinical data for the company’s mRNA drug candidate for prostate…

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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


STARMAP (Study Treating Acquired Resistance: MAPK Amplifications) is a first-in-human, 3-part, Phase 1/2 study of BBI-825 as a single agent and in combination with select targeted cancer therapies BBI-825 is a novel, oral, selective ribonucleotide reductase (RNR) inhibitor and Boundless Bio’s second extrachromosomal DNA (ecDNA)-directed therapy (ecDTx) to enter clinical development Preclinically, BBI-825 has demonstrated…

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MEI Pharma Reports Initial Data from Clinical Study Evaluating ME-344 in Combination with Bevacizumab (Avastin®) in Relapsed Metastatic Colorectal Cancer Patients


– Cohort 1 Exceeds Predetermined Non-Progression Threshold in the Ongoing Phase 1b Study – – ME-344 in Combination with Bevacizumab was Generally Well-tolerated with no Evidence of Overlapping Toxicity – – MEI to Continue Advancing ME-344 via Development of a New Formulation with the Potential to Increase Biological Activity, Patient Convenience and Commercial Opportunity –…

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