Clinical research

Guided Therapeutics and FDA Meet; Agree on Path Forward in Approval Process

Retrieved on: 
Thursday, April 30, 2020
Women, Biotechnology, Oncology, Health, FDA, Medical devices, Consumer, Clinical trials, Health, Clinical research, Medical research, Articles, Design of experiments, Pharmaceutical industry, Clinical pharmacology, Food and Drug Administration, Clinical trial, Outline of clinical research, Investigator's brochure

As a previous step, the Company filed on February 17, 2020 its FDA Pre-Submission document, which summarized LuVivas new indication for use and supporting clinical trial design.

Key Points: 
  • As a previous step, the Company filed on February 17, 2020 its FDA Pre-Submission document, which summarized LuVivas new indication for use and supporting clinical trial design.
  • Five days prior to its meeting, FDA provided the Company with written comments on its Pre-submission document detailing its approach for a new clinical trial to support U.S. approval.
  • The meeting with FDA was both positive and constructive, providing a path forward in the approval process, said Gene Cartwright, CEO.
  • The Guided Therapeutics LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.

Algernon Receives Clearance from Health Canada for Ifenprodil COVID-19 Phase 2b/3 Multinational Clinical Trial

Retrieved on: 
Thursday, April 30, 2020
Health, Clinical research, Design of experiments, Clinical pharmacology, Clinical trial, Pharmaceutical industry, Medical research

VANCOUVER, British Columbia, April 30, 2020 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc.(CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the Company or Algernon) a clinical stage pharmaceutical development company, is pleased to announce that it has received a No Objection Letter from Health Canada to proceed with a NP-120 (Ifenprodil) COVID-19 Phase 2b/3 multinational clinical trial.

Key Points: 
  • VANCOUVER, British Columbia, April 30, 2020 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc.(CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the Company or Algernon) a clinical stage pharmaceutical development company, is pleased to announce that it has received a No Objection Letter from Health Canada to proceed with a NP-120 (Ifenprodil) COVID-19 Phase 2b/3 multinational clinical trial.
  • The trial will begin as a Phase 2b study and after an interim analysis is performed on the first 100 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial.
  • With positive preliminary data, the clinical trial will move directly from a Phase 2b into a Phase 3.
  • We are very excited to have received clearance for our Phase 2b/3 study, said Christopher J. Moreau CEO of Algernon.

Worldwide Rotavirus Infections Clinical Trials Landscape: H1 2020 - ResearchAndMarkets.com

Retrieved on: 
Thursday, April 30, 2020
Infectious diseases, Health, Clinical trials, Health, Medical specialties, Medicine, Gastroenterology, Pediatrics, Clinical research, Pharmaceutical industry, Rotavirus, Clinical trial, Rotaviral gastroenteritis, Rotavirus vaccine

The "Rotavirus Infections Clinical Trials Overview, H1 2020" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Rotavirus Infections Clinical Trials Overview, H1 2020" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This clinical trials report, Rotavirus Infections Clinical Trials Overview, H1 2020 provides an overview of the Rotavirus Infections Syndrome Clinical trials scenario.
  • The report provides top line data relating to the clinical trials on Rotavirus Infections.
  • The study offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.

Acasti Pharma Announces Submission of TRILOGY 1 Briefing Package to FDA

Retrieved on: 
Thursday, April 30, 2020
Design of experiments, Clinical research, Scientific method, Blinded experiment, Articles, Science, Knowledge

Acasti continues to remain blinded to the TRILOGY 2 results, and intends to update the statistical analysis plan (SAP) with these revisions if the FDA agrees.

Key Points: 
  • Acasti continues to remain blinded to the TRILOGY 2 results, and intends to update the statistical analysis plan (SAP) with these revisions if the FDA agrees.
  • Jan DAlvise, President and CEO of Acasti Pharma, commented, We have submitted our briefing package to the FDA for their review, and are now awaiting their formal response.
  • We look forward to the FDAs feedback on our briefing package, and expect that they will provide valuable guidance on the next steps to be taken towards the unblinding of TRILOGY 2.
  • We will provide more information about our TRILOGY 1 findings, and the FDAs response to our briefing package and our questions after we get it.

Galectin Therapeutics Submits Seamless Adaptively-Designed Phase 2b/3 NASH-RX Protocol in NASH Cirrhosis

Retrieved on: 
Thursday, April 30, 2020
Health, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry, Galectin-3

Prior trials have demonstrated the safety of belapectin with doses of up to 8 mg/kg for 52 weeks (Phase 2b Study GT-026).

Key Points: 
  • Prior trials have demonstrated the safety of belapectin with doses of up to 8 mg/kg for 52 weeks (Phase 2b Study GT-026).
  • It also provides for a seamless transition of patients from the phase 2b component into the phase 3 stage, as well as provides for the potential addition of new patients.
  • Galectin Therapeutics will share more details about the protocol at the time the clinical trial begins.
  • Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer.

Science 37® and AiCure Partner to Enhance Virtual Clinical Trials

Retrieved on: 
Thursday, April 30, 2020
Health, Articles, Clinical research, Clinical pharmacology, Clinical trial, Design of experiments, Pharmaceutical industry, Telehealth, Science 37

LOS ANGELESand NEW YORK, April 30, 2020 /PRNewswire/ --Science 37, the industry leader in virtual clinical trials, and AiCure, a leading artificial intelligence (AI) and advanced data analytics company, have announced a collaboration to support and deliver enhanced technology for virtual trials.

Key Points: 
  • LOS ANGELESand NEW YORK, April 30, 2020 /PRNewswire/ --Science 37, the industry leader in virtual clinical trials, and AiCure, a leading artificial intelligence (AI) and advanced data analytics company, have announced a collaboration to support and deliver enhanced technology for virtual trials.
  • Science 37 will recruit, enroll, and support patients using its virtual model and in-house network of investigators and mobile nurses.
  • In addition, Science 37 will deliver eConsent, eSource, ePRO and telemedicine capabilities through its comprehensive clinical trial platform, the industry's first and only platform purpose-built to support virtual trials.
  • Science 37 has conducted more fully virtual, interventional clinical trials than any other organization.

Palatin Technologies Provides Assessment of Impact of COVID-19 Pandemic on Business Operations

Retrieved on: 
Thursday, April 30, 2020
Health, Articles, Peptides, Aphrodisiacs, Bremelanotide, AMAG Pharmaceuticals, Clinical research, Global health, Pharmaceuticals policy, Clinical trial, AMAG, Pandemic

During this pandemic, the safety of Palatin's employees, clinical trial patients and healthcare partners has been the Company's number one priority.

Key Points: 
  • During this pandemic, the safety of Palatin's employees, clinical trial patients and healthcare partners has been the Company's number one priority.
  • Assuming partial opening of economic activities by mid-2020, senior management believes there will be limited impact of the pandemic on operations.
  • Palatin is not responsible for updating for events that occur after the date of this press release.
  • Vyleesi is a registered trademark of AMAG Pharmaceuticals, Inc. in North America and of Palatin Technologies, Inc. elsewhere in the world.

WPD Pharmaceuticals and CNS Pharmaceuticals Identify Leading Polish Medical Institutions for Berubicin Phase 2 Clinical Trial

Retrieved on: 
Thursday, April 30, 2020
Health, Clinical research, Pharmaceutical industry, Clinical pharmacology, Clinical trial, Design of experiments, Pharmacology

The US Phase 2 trial Sponsor will be CNS and the Polish Phase 2 trial Sponsor will be WPD, a Polish corporation founded by Professor Waldemar Priebe, founder of both WPD and CNS.

Key Points: 
  • The US Phase 2 trial Sponsor will be CNS and the Polish Phase 2 trial Sponsor will be WPD, a Polish corporation founded by Professor Waldemar Priebe, founder of both WPD and CNS.
  • The Company expects to initiate both its Phase 2 US and Polish trial of Berubicin in adults with GBM during the second half of 2020.
  • As previously announced, WPD entered into a sublicense agreement with CNS, which gives WPD commercial rights in selected territories in Europe and Asia to Berubicin.
  • Proceeds from this grant will be used to support the Companys upcoming Phase 2 clinical trial of Berubicin in adults with GBM in Poland.

CalciMedica Expands Clinical Study to Assess CM4620-IE in Patients with Critical COVID-19 Pneumonia on High-Flow Oxygen Therapy

Retrieved on: 
Thursday, April 30, 2020
Health, Medicine, Clinical medicine, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry, Demand valve oxygen therapy, Idiopathic pulmonary fibrosis

This additional study arm gives us the opportunity to treat patients with COVID-19 pneumonia at a more advanced stage of lung dysfunction using our fast-acting agent, CM4620-IE.

Key Points: 
  • This additional study arm gives us the opportunity to treat patients with COVID-19 pneumonia at a more advanced stage of lung dysfunction using our fast-acting agent, CM4620-IE.
  • The open-label Phase 2 clinical study aims to enroll a total of 120 patients with COVID-19 pneumonia.
  • The additional study arm in critical patients on high-flow oxygen therapy also aims to enroll 40 patients randomized to receive CM4620-IE and 20 randomized to receive standard of care alone.
  • Patients receiving high flow oxygen therapy are differentiated from patients receiving low flow oxygen therapy as they are considered critical rather than severe by the FDA.

Contactless COVID-19 Clinical Study Starts in Ontario

Retrieved on: 
Thursday, April 30, 2020
Health, Pharmaceutical industry, Clinical research, Clinical pharmacology, Clinical trial, Design of experiments, Pharmacology

As of today, Ontarians who are tested positive for COVID-19, but are not hospitalized, may be eligible for this innovative, contactless at-home study.

Key Points: 
  • As of today, Ontarians who are tested positive for COVID-19, but are not hospitalized, may be eligible for this innovative, contactless at-home study.
  • Dr. Tardif and the MHI are working to also bring this clinical trial to other provinces/sites as soon as possible.
  • Physicians with patients, or people with a positive COVID-19 diagnosis who are interested in participating in the clinical study, can call the hotline any time at 1-877-536-6837.
  • The study will be monitored by a data monitoring committee (DMC) that includes experienced clinical researchers.