Trial of the century

AAVantgarde announces its innovative clinical study design for its lead program in Usher 1B

Retrieved on: 
Friday, May 3, 2024
University, Summit, Retinitis pigmentosa, Hope, Trial of the century, Principal investigator, AAV, Patient, Principal, Gene, Health, Clinical trial, USH1B, Usher syndrome, Medical device

The LUCE-1 clinical study is a first-in-human Phase 1/2 clinical study designed in collaboration with Prof. Simonelli and other leading experts in the field.

Key Points: 
  • The LUCE-1 clinical study is a first-in-human Phase 1/2 clinical study designed in collaboration with Prof. Simonelli and other leading experts in the field.
  • Leveraging AAVantgarde’s proprietary Dual Hybrid platform, this study aims to provide robust evidence supporting the effectiveness and safety profile of the Company’s lead program, AAVB-081, that addresses the retinitis pigmentosa derived from MYO7A-related Usher syndrome (USH1B).
  • “I am delighted to be presenting the pre-clinical and clinical activities that paved the way to the design of this first-in-human Phase 1/2 clinical study at the Summit.
  • Through this innovative design, we aim to revolutionize our approach to understanding and treating Usher 1B patients.

Castle Biosciences Reports First Quarter 2024 Results

Retrieved on: 
Thursday, May 2, 2024
Oncology, Mental Health, Health, Biometrics, General Health, Pharmaceutical, Biotechnology, Epidemiology, NCCN, News, Hospital, Risk, Recurrence, Lymph node, ART, Patient, Metastasis, Medicare, Trial of the century, Melanoma, Pharmaceutical industry

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the first quarter ended March 31, 2024.
  • Delivered 20,888 total test reports in the first quarter of 2024, an increase of 40% compared to 14,916 in the same period of 2023:
    DecisionDx-Melanoma test reports delivered in the quarter were 8,384 compared to 7,583 in the first quarter of 2023, an increase of 11%.
  • MyPath® Melanoma test reports delivered in the quarter were 998, compared to 980 MyPath Melanoma and DiffDx®-Melanoma aggregate test reports in the first quarter of 2023, an increase of 2%.
  • Castle Biosciences will hold a conference call on Thursday, May 2, 2024, at 4:30 p.m. Eastern time to discuss its first quarter 2024 results and provide a corporate update.

Ventus Therapeutics Announces First Participant Dosed in Clinical Study with an NLRP3 Inhibitor Licensed Exclusively to Novo Nordisk

Retrieved on: 
Friday, May 3, 2024
Mental Health, Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Obesity, NLRP3, Therapy, Novo Nordisk, Senior, Partnership, Trial of the century, Chronic kidney disease, Safety, MASH, Pharmacokinetics, Pharmaceutical industry

Ventus Therapeutics, Inc. , a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today announced that its partner, Novo Nordisk, has successfully dosed the first participant in a Phase 1 clinical study for NNC6022-0001 (formerly known as VENT-01) – an oral NLRP3 inhibitor licensed by Novo Nordisk in September 2022.

Key Points: 
  • Ventus Therapeutics, Inc. , a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today announced that its partner, Novo Nordisk, has successfully dosed the first participant in a Phase 1 clinical study for NNC6022-0001 (formerly known as VENT-01) – an oral NLRP3 inhibitor licensed by Novo Nordisk in September 2022.
  • “NLRP3 inhibitors have potential in a wide variety of cardiometabolic diseases, including obesity, metabolic dysfunction-associated steatohepatitis (MASH), and chronic kidney disease.
  • Since the beginning of our partnership with Ventus, we have seen additional evidence for the broad range of opportunities addressable by targeting NLRP3,” said Karin Conde-Knape, Ph.D., Senior Vice President of Global Drug Discovery at Novo Nordisk.
  • “This trial initiation marks the first stage in our NLRP3 inhibitor clinical program, and we are eager to be a key player in this expanding field.”
    The Phase 1 study is designed to fully explore the pharmacokinetics, pharmacodynamics, and safety of NNC6022-0001 across a broad range of doses in healthy volunteers.

Palatin Announces FDA Clearance of IND Application for the Co-Administration of Bremelanotide with Tirzepatide (GLP-1) for the Treatment of Obesity

Retrieved on: 
Thursday, May 2, 2024
FDA, Patient, Effectiveness, Incretin, Woman, Food, Health, Bremelanotide, Trial of the century, Human, Weight loss, Research, Peptide, Melanocortin, IND, KOL, University college, Therapy, Treatment, Rat, Standard of care, PTN, Quality of life, Calendar, Pharmaceutical industry

The study is designed to enroll up to 60 patients actively on tirzepatide at approximately five trial sites in the U.S.

Key Points: 
  • The study is designed to enroll up to 60 patients actively on tirzepatide at approximately five trial sites in the U.S.
  • The primary endpoint of the trial is to demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight.
  • Patients will be treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment regimens.
  • "Therapeutic options for obesity treatment requires multiple pathways to safely, effectively, and consistently treat and maintain weight loss.

SwiftDuct Presents Positive Clinical Study Results of SwiftGlide For ERCP Procedures at ESGE Days 2024

Retrieved on: 
Thursday, May 2, 2024
Electrochemistry, Dielectric spectroscopy, Bar-Ilan University, Poster, Gastrointestinal Endoscopy, Trial of the century, ESGE, Fluoroscopy, Bile, Pancreatic duct, Patient, EMMS Nazareth Hospital, Pancreatitis, Galilee Medical Center, Assistant, ERCP, Clinical trial, Medical imaging

SAKHNIN, Israel, May 2, 2024 /PRNewswire/ -- In a poster presentation at the 2024 annual meeting of the European Society of Gastrointestinal Endoscopy, ESGE Days 2024, SwiftDuct announced the positive findings of the first clinical trial of SwiftGlide™, the company's electrochemical navigation system for ERCP procedures.

Key Points: 
  • SwiftDuct's first clinical study, which was conducted at Galilee Medical Center, demonstrates that the company's electrochemical navigation method has the potential to improve ERCP procedures and outcomes, marking an important milestone towards Fluoroscopy-Free ERCP cannulation.
  • ERCP is a widely used procedure to diagnose and treat issues in the bile or pancreatic ducts.
  • SAKHNIN, Israel, May 2, 2024 /PRNewswire/ -- In a poster presentation at the 2024 annual meeting of the European Society of Gastrointestinal Endoscopy, ESGE Days 2024 , SwiftDuct announced the positive findings of the first clinical trial of SwiftGlide™, the company's electrochemical navigation system for ERCP procedures.
  • The study showed that SwiftGlide™ was successful in differentiating between bile and pancreatic/mixed juices as the basis to providing selective and safe biliary cannulation during ERCP procedures.

MongoDB Announces General Availability of MongoDB Atlas Vector Search Integration with Amazon Bedrock

Retrieved on: 
Thursday, May 2, 2024
Knowledge, Amazon Web Services, Atlas, MongoDB, Meta, FMS, RAG, API, Obesity, Therapy, Mistral, Novo Nordisk, Organization, Synthetic media, Stability, Privacy, Generative, Trial of the century, AWS, Cohere, Online shopping

NEW YORK, May 2, 2024 /PRNewswire/ -- MongoDB, Inc. (NASDAQ: MDB) today at its developer conference MongoDB.local NYC announced the general availability of MongoDB Atlas Vector Search on Knowledge Bases for Amazon Bedrock to enable organizations to build generative AI application features using fully managed foundation models (FMs) more easily. MongoDB Atlas is the world's most widely available developer data platform and provides vector database capabilities that make it seamless for organizations to use their real-time operational data to power generative AI applications. Amazon Bedrock is a fully managed service from Amazon Web Services (AWS) that offers a choice of high-performing FMs from leading AI companies via a single API, along with a broad set of capabilities organizations need to build generative AI applications with security, privacy, and responsible AI. Customers across industries can now use the integration with their proprietary data to more easily create applications that use generative AI to autonomously complete complex tasks and to deliver up-to-date, accurate, and trustworthy responses to end-user requests.

Key Points: 
  • NEW YORK, May 2, 2024 /PRNewswire/ -- MongoDB, Inc. (NASDAQ: MDB) today at its developer conference MongoDB.local NYC announced the general availability of MongoDB Atlas Vector Search on Knowledge Bases for Amazon Bedrock to enable organizations to build generative AI application features using fully managed foundation models (FMs) more easily.
  • The new integration with Amazon Bedrock allows organizations to more quickly and easily deploy generative AI applications on AWS that can act on data processed by MongoDB Atlas Vector Search to deliver more accurate, relevant, and trustworthy responses.
  • Customers can use the integration between MongoDB Atlas Vector Search and Amazon Bedrock to privately customize FMs like large language models (LLMs)—from AI21 Labs, Amazon, Anthropic, Cohere, Meta, Mistral AI, and Stability AI—with their real-time operational data by converting it into vector embeddings for use with LLMs.
  • Now with MongoDB Atlas Vector Search generally available on Knowledge Bases for Amazon Bedrock, our shared customers can more easily and quickly implement retrieval augmented generation (RAG) to glean greater insights from their data."

Foresee Pharmaceuticals Announces First Subject Dosed in its First-in-Human Clinical Trial of FP-020

Retrieved on: 
Tuesday, April 30, 2024
Foresight, Clinical trial, Trial of the century, Asthma, Safety, Pharmacokinetics, COPD, Pharmaceutical industry

TAIPEI, April 30, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced that the first subject has been dosed in its Phase 1 clinical trial of FP-020 in Australia.

Key Points: 
  • TAIPEI, April 30, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced that the first subject has been dosed in its Phase 1 clinical trial of FP-020 in Australia.
  • The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-center, single, and multiple ascending oral dose study to evaluate the safety, tolerability, and pharmacokinetics of FP-020 in healthy volunteers.
  • "The initiation of this Phase 1 trial underscores our commitment to advancing innovative therapies to benefit patients with severe asthma and COPD.
  • Additionally, we are working diligently to build a broad franchise leveraging our multiple MMP-12 inhibitors across several therapeutic areas."

Biophytis announces new Scientific Advisory Board for its phase 2 OBA clinical study in obesity

Retrieved on: 
Friday, May 3, 2024
FDA, Upjohn, Cytoprotection, Research, Geriatrics, Trial of the century, Doctor of Philosophy, IND, Hepatology, Prostaglandin, Baylor University, SAB, Endocrinology, Baylor College of Medicine, Ageing, Diabetes, Euronext Growth, Gastroenterology, Wellcome Research Laboratories, Obesity, Therapy, Royal Free Hospital, Notifiable disease, Investigational New Drug, OBA, GLP1, Frailty, Consultant, MD, Facial muscles, Digestion, Patient, Metabolism, Sarcopenia, Internal medicine, Pharmaceutical industry

The OBA SAB will guide the company to develop BIO101 (20-hydroxyecdysone) in obesity, in combination with GLP1-RA, and will actively work towards the finalization of the OBA Phase 2 clinical study design.

Key Points: 
  • The OBA SAB will guide the company to develop BIO101 (20-hydroxyecdysone) in obesity, in combination with GLP1-RA, and will actively work towards the finalization of the OBA Phase 2 clinical study design.
  • Biophytis plans to file for an Investigational New Drug (IND) application to start the OBA Phase 2 clinical study in the USA with FDA in the coming weeks.
  • Stanislas Veillet, CEO de Biophytis states: “We are pleased to announce the appointment of Professor Dennis Villareal and Professor Francisco Guarner to the Scientific Advisory Board of the OBA Phase 2 study.
  • We are preparing with the SAB to file for an IND to start the OBA phase 2 clinical study in the coming weeks.”
    The first two members of Biophytis’ new Scientific Advisory Board for the OBA clinical study are:
    at Baylor College of Medicine, Houston, Texas, United States.

EQS-News: Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next-Gen CRC Test

Retrieved on: 
Friday, May 3, 2024
FDA, Cancer, CDC, Colorectal cancer, CRC, Trial of the century, Polyp, Patient, Colonoscopy, FIT, Gene expression, Messenger, Biomarker, PMA, Medical imaging

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.

Key Points: 
  • “We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.
  • Hence these results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.
  • Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.
  • The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

Cardiff Oncology Reports First Quarter 2024 Results and Provides Business Update

Retrieved on: 
Thursday, May 2, 2024
Clinical Cancer Research, SCLC, CRDF, RAS, Trial of the century, Carcinoma, Patient, AACR, Cancer, Bev, PLK1, Ovarian cancer, SAN, Pharmaceutical industry

Company highlights for the quarter ended March 31, 2024 and subsequent weeks include:

Key Points: 
  • Company highlights for the quarter ended March 31, 2024 and subsequent weeks include:
    Presented updated data at AACR Annual Meeting 2024 that supports ongoing first-line RAS-mutated mCRC clinical study.
  • Contingent upon the results, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
  • As of March 31, 2024, Cardiff Oncology had approximately $67.2 million in cash, cash equivalents, and short-term investments.
  • Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on May 2, 2024.