Biotechnology

Neurophth Announces First Patient Dosed in Phase I/II Clinical Trial of Second Gene Therapy

08/24/2023

Excerpt from the Press Release: WUHAN, China and SAN DIEGO, Aug. 17, 2023 /PRNewswire/ — Neurophth Therapeutics, Inc. (“Neurophth”) announced today that the first patient has been dosed in the international multi-region, multi-center Phase I/II clinical trial for the treatment of Leber hereditary optic neuropathy caused by ND1 mutation (ND1-LHON). Neurophth is conducting a Phase I/II,…

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CymaBay Initiates IDEAL, a Phase 3 Placebo-Controlled, Randomized Study of Seladelpar in Patients with Primary Biliary Cholangitis and Incomplete Control of Alkaline Phosphatase

08/17/2023

valuates seladelpar 10 mg vs. placebo for alkaline phosphatase normalization at 52 weeks Patients enroll with alkaline phosphatase levels between 1- and 1.67-times upper limit of normal Excerpt from the Press Release: NEWARK, Calif., Aug. 10, 2023 /PRNewswire/ — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies…

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Jnana Therapeutics Announces Dosing of First Participant in Phase 1b Clinical Trial of JNT-517 in Individuals with PKU

08/15/2023

JNT-517 is a Potential First-in-Class Oral Treatment for PKU; Phase 1b Study Follows Positive Clinical Proof of Mechanism Data in Healthy Individuals Upcoming Oral Presentation of Phase 1a Study Results at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023 Excerpt from the Press Release: BOSTON, Aug. 09, 2023 (GLOBE…

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LianBio Announces First Patient Treated in Phase 1 Trial of SHP2 Inhibitor BBP-398 in Combination with Osimertinib in Patients with Non-Small Cell Lung Cancer with EGFR Mutations

08/11/2023

Excerpt from the Press Release: SHANGHAI, China and PRINCETON, N.J., Aug. 03, 2023 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, an investigational SHP2 inhibitor,…

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Celsius Therapeutics Announces Initiation of Dosing in Phase 1 Clinical Trial of CEL383, an Anti-TREM1 Antibody for the Treatment of Inflammatory Bowel Disease

08/07/2023

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celsius Therapeutics, a biotechnology company pioneering new precision medicines for patients with inflammatory disease by harnessing the power of single-cell RNA sequencing and human biology at scale, today announced the initiation of dosing in the company’s first-in-human Phase 1 clinical trial of CEL383 in healthy volunteers. CEL383 is…

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Elixir Medical Completes Enrollment of INFINITY-SWEDEHEART Clinical Trial

07/20/2023

-Largest randomized trial of DynamX Bioadaptor to date with 2,400 patients enrolled, covering real-world population- Excerpt from the Press Release: MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of breakthrough cardiovascular technologies, today announced enrollment completion in INFINITY-SWEDEHEART, a prospective, multicenter, single-blind, randomized clinical trial of the DynamX® Coronary Bioadaptor System, the first metallic coronary artery implant…

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Blue Lake Biotechnology Doses First Child in Clinical Trial of Novel Intranasal Vaccine Against Respiratory Syncytial Virus

07/12/2023

Excerpt from the Press Release: ATHENS, Ga. and LOS GATOS, Calif., June 29, 2023 /PRNewswire/ — Blue Lake Biotechnology, Inc., a clinical stage intranasal vaccine company harnessing the full breadth of the immune system to protect against serious infectious disease, announced that the first child has been dosed in its Phase 1/2a trial (NCT05655182) of…

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Capricor Therapeutics Announces Positive 24-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy

07/07/2023

-Improvements in Left Ventricular Ejection Fraction (LVEF) for the M ajority of Patients Suggest Preservation of Cardiac Function- -Results in Performance of the Upper Limb PUL v2.0 Continue to Show Long-Term Benefit in Skeletal Muscle Function (p=0.02)- -Safety and Efficacy Results Continue to Suggest Potential Disease Attenuation in Duchenne Muscular Dystrophy (DMD) Excerpt from the…

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Oncolytics Biotech’s® Pelareorep Selected for Inclusion in Precision PromiseSM Pivotal Phase 3 Platform Trial

06/29/2023

Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic…

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Epic Bio Presents Compelling Preclinical Data Supporting Clinical Initiation of EPI-321 for FSHD

06/28/2023

– NHP studies demonstrate EPI-321’s favorable safety and pharmacokinetic profile – – IND and CTA applications planned for 2023 – Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., June 16, 2023 (GLOBE NEWSWIRE) — Epic Bio, a biotechnology company developing therapies to modulate gene expression using compact, non-cutting dCas proteins, today presented new non-human…

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