Phases of clinical research

Altasciences Performs Phase I Studies for FDA Approval of Vibegron

Tuesday, February 23, 2021 - 4:52pm

Altasciences is pleased to have contributed to the recent FDA approval of Vibegron, by performing three early phase clinical trials.

Key Points: 
  • Altasciences is pleased to have contributed to the recent FDA approval of Vibegron, by performing three early phase clinical trials.
  • We take tremendous pride in contributing to the FDA approval of much-needed medicines that improve the health and wellbeing of patients, said Amy Denvir, General Manager at Altasciences Kansas clinical pharmacology unit.
  • Altasciences expert clinical teams provided clinical support for two drug-drug interaction studies and a bioavailability trial, conducted in 2018 and 2019, in healthy subjects.
  • These trials were supported by Altasciences data services team, who performed the full data management and reporting for the associated clinical studies.

First-in-Class GPR119 Agonist of Dong-A ST, DA-1241 Improved Glucose Control in Patients With Type 2 Diabetes in US Phase 1b Study

Monday, February 8, 2021 - 1:00pm

It conducted Phase 1a clinical study with healthy subjects (single ascending dose study) and then Phase 1b clinical study with both healthy subjects and type-2 diabetic patients (multiple ascending dose study).

Key Points: 
  • It conducted Phase 1a clinical study with healthy subjects (single ascending dose study) and then Phase 1b clinical study with both healthy subjects and type-2 diabetic patients (multiple ascending dose study).
  • The results of this Phase 1b study are meaningful in that non-clinical differentiation of DA-1241 was translated in a clinical study.
  • After confirming differentiations of DA-1241 in the pre-clinical program, Dong-A ST conducted Phase 1a clinical study and Phase 1b clinical study, respectively in the United States.
  • Building on the successful completion of Phase 1b clinical study of DA-1241, Dong-A ST is preparing for Phase 2 clinical study to evaluate the efficacy for diabetes and dyslipidemia.

Selva Therapeutics Announces Successful Completion of Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

Tuesday, February 2, 2021 - 2:00pm

Selva Therapeutics, Inc. today announced that the Phase 1 clinical study met its primary objective of demonstrating safety and tolerability of SLV213, a potential oral treatment for COVID-19.

Key Points: 
  • Selva Therapeutics, Inc. today announced that the Phase 1 clinical study met its primary objective of demonstrating safety and tolerability of SLV213, a potential oral treatment for COVID-19.
  • The company plans to rapidly advance SLV213 into a Phase 2 study in non-hospitalized COVID-19 patients.
  • The Phase 1 study was a randomized, placebo-controlled, double-blinded study conducted in healthy volunteers.
  • We successfully completed our Phase 1 study with no dose-limiting toxicity, said Ken Krantz M.D., Ph.D., Chief Medical Officer of Selva Therapeutics.

Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trials for STI-2020 (COVI-AMG) in Healthy Volunteers and in Newly Diagnosed COVID-19 Patients

Wednesday, December 9, 2020 - 2:00pm

FDA has granted clearance for the commencement of Phase 1 clinical trials of STI-2020 (COVI-AMGTM) in healthy volunteers and COVID-19 patients with mild symptoms.

Key Points: 
  • FDA has granted clearance for the commencement of Phase 1 clinical trials of STI-2020 (COVI-AMGTM) in healthy volunteers and COVID-19 patients with mild symptoms.
  • Outpatient trials are expected to enroll quickly and will be followed by pivotal trials to potentially support an EUA (Emergency Use Authorization) submission.
  • SAN DIEGO, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc.(Nasdaq: SRNE, Sorrento) announced today FDA acceptance of its Investigational New Drug (IND) application for its Phase 1 clinical trials for intravenous (IV)STI-2020 (COVI-AMG).
  • The trials will evaluate the safety, pharmacokinetics and efficacy of a single injection of STI-2020 in healthy volunteers and outpatient COVID-19 patients with mild symptoms.

uniQure Announces Two-Year Follow-Up Data from the Phase IIb Study of Etranacogene Dezaparvovec and Long-Term Follow-Up Data for AMT-060 in Patients with Hemophilia B

Monday, December 7, 2020 - 9:05pm

At Least Two Years of Stable, Therapeutic Levels of FIX Activity in Patients Treated with Etranacogene Dezaparvovec

Key Points: 
  • At Least Two Years of Stable, Therapeutic Levels of FIX Activity in Patients Treated with Etranacogene Dezaparvovec
    The Phase IIb study of etranacogene dezaparvovec is an open-label, single-dose, single-arm, multi-center trial being conducted in the United States.
  • In todays oral presentation at ASH, two-year follow-up data show that all three patients have sustained FIX activity at therapeutic levels after the one-time administration of etranacogene dezaparvovec.
  • The data offer encouraging support for the potential long-term benefits of etranacogene dezaparvovec, which are being further characterized in the ongoing Phase 3 HOPE-B study.
  • Data from this Phase I/II trial of AMT-060 also will be part of the regulatory submissions for marketing approval of etranacogene dezaparvovec.

Enlivex Reports Positive Interim Results From Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients

Thursday, December 3, 2020 - 1:00pm

The Phase II patients that have been discharged from the hospital are currently healthy.

Key Points: 
  • The Phase II patients that have been discharged from the hospital are currently healthy.
  • Oren Hershkovitz, Ph.D., CEO of Enlivex commented, We are pleased with the interim results of this COVID-19 Phase II clinical trial.
  • We believe that AllocetraTM, if approved, could potentially cover the void that currently exists in treatments for severe or critical COVID-19 patients.
  • The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals.

Global Pharmacovigilance Market Size, Share & Trends Analysis Report 2020 with COVID-19 Impact Analysis - ResearchAndMarkets.com

Tuesday, December 1, 2020 - 10:13am

The "Pharmacovigilance Market Size, Share & Trends Analysis Report by Product Life Cycle, by Service Provider, by Type, by Therapeutic Area, by Process Flow, by End-use, and Segment Forecasts, 2020-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pharmacovigilance Market Size, Share & Trends Analysis Report by Product Life Cycle, by Service Provider, by Type, by Therapeutic Area, by Process Flow, by End-use, and Segment Forecasts, 2020-2027" report has been added to ResearchAndMarkets.com's offering.
  • According to the National Center for Biotechnology Information (NCBI), approximately 5% of total hospitalizations in Europe each year, are due to ADR.
  • Pharmacovigilance services play an integral role in this clinical trial phase by assisting manufacturers in identifying adverse effects associated with the drug.
  • Moreover, companies are adopting strategies including new product launch, collaborations, and mergers & acquisitions to gain a competitive advantage
    Chapter 3 Pharmacovigilance Market Variables, Trends & Scope

New Centre for Medicines Research (CMR) Clinical Factbook From Clarivate Highlights Increasing Cost and Complexity of Phase II Trials

Tuesday, November 24, 2020 - 8:05am

The factbook reveals clinical trial volume has increased by 7% between 2014 and 2019 with Phase II trials accounting for the majority of trials initiated during the period.

Key Points: 
  • The factbook reveals clinical trial volume has increased by 7% between 2014 and 2019 with Phase II trials accounting for the majority of trials initiated during the period.
  • The annual publication provides insights on clinical study, country and site level metrics from Phase I through Phase IV.
  • Leading pharmaceutical and biotechnology companies can assess clinical productivity and leverage industry trends and insights to make informed clinical planning decisions.
  • The 2020 CMR International Pharmaceutical Clinical Factbook indicates, while Phase I and II clinical trials tend to be the most complex, Phase III trials have also seen an increase in complexity.

New Centre for Medicines Research (CMR) Clinical Factbook From Clarivate Highlights Increasing Cost and Complexity of Phase II Trials

Tuesday, November 24, 2020 - 8:05am

The factbook reveals clinical trial volume has increased by 7% between 2014 and 2019 with Phase II trials accounting for the majority of trials initiated during the period.

Key Points: 
  • The factbook reveals clinical trial volume has increased by 7% between 2014 and 2019 with Phase II trials accounting for the majority of trials initiated during the period.
  • The annual publication provides insights on clinical study, country and site level metrics from Phase I through Phase IV.
  • Leading pharmaceutical and biotechnology companies can assess clinical productivity and leverage industry trends and insights to make informed clinical planning decisions.
  • The 2020 CMR International Pharmaceutical Clinical Factbook indicates, while Phase I and II clinical trials tend to be the most complex, Phase III trials have also seen an increase in complexity.

Development of COVID-19 Vaccine AZD1222 Expands Into US Phase III Clinical Trial Across All Adult Age Groups

Monday, August 31, 2020 - 9:53pm

Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials are planned to start in Japan and Russia.

Key Points: 
  • Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials are planned to start in Japan and Russia.
  • These trials, together with the US Phase III clinical trial will enroll up to 50,000 participants globally.
  • Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.
  • Individuals interested in participating in the Phase III D8110C00001 vaccine trial can visit https://www.c19vaccinestudy.com or www.CoVPN.org websites for more information.