Suono Bio Reports Encouraging Results From First in Human Study of Ultrasound Mediated Drug Delivery Platform

Suono Bio Reports Encouraging Results From a First in Human (FiH) Study of Its Ultrasound Mediated Drug Delivery Platform In a recent study, Suono Bio Inc. has unveiled promising findings from its first clinical trial testing the SuonoCalm™ platform. This groundbreaking study demonstrates the feasibility and safety of using ultrasound for drug delivery in the gastrointestinal tract. The study co..

BioRestorative Therapies' Drug Candidate BRTX-100 Passes Safety Test With Flying Colors, Moves Ahead With Phase 2 And Looks To Expand Pipeline Opportunities

BioRestorative Therapies' drug candidate BRTX-100 has successfully passed a safety test and is now moving forward with its Phase 2 clinical trial. The trial focuses on chronic lumbar disc disease, and the independent review board overseeing the trial has unanimously recommended its continuation without any changes to the protocol. &nbsp This recommendation from the Data Safety Monitoring Board (..

Simcha Therapeutics Announces First Patient Dosed in Phase 1/2 Study Evaluating ST-067 in Combination with KEYTRUDA® (Pembrolizumab) in Patients with Various Solid Tumors

Simcha Therapeutics, a clinical-stage immunobiology company, has announced that the first patient has been dosed in a Phase 1/2 clinical trial of ST-067 in combination with Merck's anti-PD-1 therapy, KEYTRUDA®, for patients with advanced solid tumors. The study aims to determine the maximum tolerated dose and preliminary activity of the combination treatment. Simcha Therapeutics has observed pro..

Simufilam Slowed Cognitive Decline in a Randomized Withdrawal Trial of Mild-to-Moderate Alzheimer’s Disease

Positive Interim Updates from ReSPECT™ Clinical Trials Presented at SNMMI Annual Meeting

Plus Therapeutics, a clinical-stage pharmaceutical company, announced positive interim updates from its ReSPECT™ clinical trials at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting. The ReSPECT-GBM Phase 1 trial showed safety and overall survival correlation with absorbed radiation dose in recurrent glioblastoma patients. The ReSPECT-LM Phase 1/Part A trial demonstrated..

SK Bioscience and Sanofi Announce Positive Results from Phase II Study of 21-Valent Pneumococcal Conjugate Vaccine Candidate

SK bioscience and Sanofi have announced positive results from the Phase II study of their 21-valent pneumococcal conjugate vaccine candidate, GBP410 (also known as SP0202). The vaccine demonstrated positive safety and immunogenicity data in infants. The companies plan to start Phase III trials in the first half of 2024. The Phase II clinical trial evaluated the safety and immunogenicity of GBP41..

Delta-Fly Pharma Inc. Provides Schedule for Interim Analysis of Phase 3 Study of DFP-10917 in R/R AML

Delta-Fly Pharma Inc. has announced the schedule for the interim analysis of the Phase 3 study of DFP-10917 in relapsed/refractory acute myeloid leukemia (R/R AML) patients. The interim analysis will be based on outcome measurements including complete remission rate, overall survival, and safety. The first data processing is scheduled to be completed in mid-July 2023, followed by the second data..

First Wave BioPharma Announces Final Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation

First Wave BioPharma, a clinical-stage biopharmaceutical company specializing in gastrointestinal (GI) diseases, has announced that the final patient has been dosed in the Phase 2 SPAN clinical trial. The trial is investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients. Topline..

First Wave BioPharma Strengthens Intellectual Property Estate

First Wave BioPharma, a clinical-stage biopharmaceutical company specializing in gastrointestinal (GI) diseases, has announced the publication of two patent applications for its enhanced enteric microgranule delivery formulation of adrulipase. The patents cover composition of matter and methods of use claims and were published by both the United States Patent and Trademark Office (USPTO) and the..

PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer

PDS Biotechnology has achieved the efficacy threshold in Stage 2 of the VERSATILE-002 trial with PDS0101 and KEYTRUDA® for head and neck cancer. The trial evaluates PDS0101, an HPV-targeted immunotherapy, combined with Merck’s anti-PD-1 therapy for the treatment of unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. Fourteen patients in the immune ch..