Nanodropper, Inc., an ophthalmic device company that created the eyedrop volume-reducing Nanodropper® Adaptor, announced today that its clinical trial “An Evaluation of the Efficacy and Safety of Timolol Maleate 0.5% Microdrops Administered with the Nanodropper” was published in the journal Ophthalmology. This was a prospective, multicenter, randomized, parallel-group, single-masked, active-controlled, non-inferiority trial. The trial enrolled glaucoma patients and demonstrated […]
Tag: Clinical Trial
Atrogi Announces Positive Clinical Data from First-in-Class Insulin-Independent Treatment for Type 2 Diabetes
Atrogi, a pioneering clinical-stage biotech company advancing treatments for metabolic disorders, announces the full set of results from its Phase 1 a/b trial with ATR-258, its first-in-class treatment for type 2 diabetes (T2D). This clinical trial, conducted on both healthy volunteers and individuals with T2D, underscores the safety of ATR-258 as a novel β2-adrenoceptor agonist, […]
Recce Pharmaceuticals Doses Next Cohort in Phase I/II Trial of RECCE® 327 for Urinary Tract Infections and Urosepsis
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it dosed the next cohort of healthy subjects at 3,000mg within a fast infusion rate of 20-minutes in a Phase I/II trial evaluating its lead candidate, RECCE® 327 (R327). “We’re pleased to continue advancing the clinical […]
Ocugen, Inc. Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 1 of Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410
Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced […]
Arctic Therapeutics and Nacuity Pharmaceuticals Announce European Medicines Agency Approval to Initiate First Clinical Trial of AT-001 (NPI-001) for the Treatment of HCCAA
Arctic Therapeutics ehf, an Icelandic drug development company and partner Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other diseases caused by oxidative stress, today announced approval by the European Medicines Agency (EMA) for initiation of the first clinical trial evaluating AT-001 (Nacuity’s NPI-001) for the treatment of Hereditary […]
First Patient Treated in Phase 2 GvHD Trial
Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, confirms that the first patient has been enrolled and treated in its Phase 2 clinical trial of CYP-001 in high-risk acute graft versus host disease (aGvHD). CYP-001 is Cynata’s Cymerus™ off-the-shelf iPSC[1]-derived MSC[2] product candidate for intravenous infusion, which previously generated very encouraging safety […]
PepGen Announces Clearance of CTA by UK Medicines & Healthcare Products Regulatory Agency to Begin CONNECT2-EDO51, a Phase 2 Clinical Trial designed to support potential accelerated approval of PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy
PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has authorized its Clinical Trial Application (CTA) to initiate the CONNECT2-EDO51 Phase 2 clinical trial […]
RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by […]
Ultimovacs announces publication of results from NIPU Phase II trial with UV1 vaccination in mesothelioma in European Journal of Cancer
Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced that the results from the randomized controlled Phase II clinical trial, NIPU, are published in the European Journal of Cancer. The trial investigates the effect of adding Ultimovacs’ cancer vaccine UV1 to second-line treatment with ipilimumab and nivolumab for patients with […]
Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical stage of its Phase 1, single ascending dose escalation trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy volunteers. TNX-1500 is in development for the prevention of […]