Blinded experiment

Citius Pharmaceuticals Achieves Next Interim Analysis Milestone in its Mino-Lok® Phase 3 Trial

Retrieved on: 
Tuesday, June 8, 2021

"We look forward to feedback from the DMC following their review of the trial data," stated Myron Holubiak, President and Chief Executive Officer of Citius.

Key Points: 
  • "We look forward to feedback from the DMC following their review of the trial data," stated Myron Holubiak, President and Chief Executive Officer of Citius.
  • The first two interim analyses were conducted by the DMC in 2019 and 2020, respectively.
  • The next interim analysis meeting of the DMC will be held on June 29, 2021.
  • At that time, the DMC will review unblinded study data and subsequently provide written recommendations to Citius within five business days.

AB Science is providing a summary of the live webcast held on June 3, 2021 following the voluntary hold in the clinical studies of masitinib

Retrieved on: 
Tuesday, June 8, 2021

SUMMARY OF THE WEBCAST HELD ON JUNE 3, 2021 FOLLOWING THE VOLUNTARY HOLD IN THE CLINICAL STUDIES OF MASITINIB

Key Points: 
  • SUMMARY OF THE WEBCAST HELD ON JUNE 3, 2021 FOLLOWING THE VOLUNTARY HOLD IN THE CLINICAL STUDIES OF MASITINIB
    RESUMPTION OF TRADING ON WEDNESDAY JUNE 9, 2021
    AB Science SA (NYSE Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on June 3, 2021 following the voluntary hold in the clinical studies of masitinib.
  • AB Science took the decision to temporarily hold the inclusions of new patients because of a potential signal of ischemic heart disease.
  • After unblinding the phase 2B/3 studies with masitinib, AB Science ran multiple safety analyses in a continuous effort to detect signals.
  • Out of precaution, AB Science decided to hold inclusions in on-going studies pending completion of these investigations.

BetterLife Selects CRO to Conduct Clinical Trials for AP-003 in COVID-19 Cases in Indonesia

Retrieved on: 
Thursday, January 21, 2021

Jakarta-based Equilab ( http://www.equilab-int.com ) is an internationally recognized CRO with a strong team of clinical and analytical researchers that have already conducted clinical trials in COVID-19 patients.

Key Points: 
  • Jakarta-based Equilab ( http://www.equilab-int.com ) is an internationally recognized CRO with a strong team of clinical and analytical researchers that have already conducted clinical trials in COVID-19 patients.
  • BetterLife and Equilab will conduct the placebo-controlled blinded trials in COVID-19 patients at Equilabs own 75 bed clinical facility.
  • We changed the site of our proposed AP-003 clinical trials in COVID-19 patients from Australia to Indonesia.
  • Established in 2002, Equilab is one of the leading Contract Research Organisations (CRO) in Indonesia that provides full-service clinical research for global and local clients.

Agios Presents Final Data from Phase 3 ClarIDHy Study of TIBSOVO® (ivosidenib tablets) in Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma

Retrieved on: 
Sunday, January 17, 2021

The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.

Key Points: 
  • The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.
  • As of the May 31, 2020 data cutoff, 187 patients were randomized, with 126 patients in the TIBSOVO arm and 61 patients in the placebo arm.
  • Forty-three patients randomized to placebo (70.5%) crossed over to open-label TIBSOVO upon radiographic disease progression and unblinding.
  • Agios plans to submit a supplemental new drug application for TIBSOVO in previously treated IDH1-mutant cholangiocarcinoma in the first quarter of 2021.

BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Heart Failure Study as Designed

Retrieved on: 
Thursday, December 17, 2020

The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed.

Key Points: 
  • The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed.
  • I am delighted with the positive recommendation from the distinguished CardiAMP DSMB to continue this important study, said BioCardia CEO Peter Altman, PhD.
  • The successful risk-benefit review is a testament to the dedication of the many CardiAMP investigators and clinical teams at leading institutions across the U.S.
  • The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide.

Medidata, TriNetX, and Datavant Partner to Enable Seamless Integration of Real-World Data in Clinical Development

Retrieved on: 
Thursday, October 29, 2020

Medidata, a Dassault Systmes company, TriNetX, and Datavant announced a partnership that will accelerate the use of real-world data (RWD) to power clinical research.

Key Points: 
  • Medidata, a Dassault Systmes company, TriNetX, and Datavant announced a partnership that will accelerate the use of real-world data (RWD) to power clinical research.
  • This partnership will enable users of Medidatas end-to-end clinical research platform to securely link their clinical data with patient consent to de-identified patient data without unblinding the study.
  • Pooled clinical trial data is increasingly being used to design synthetic control arms, and even to power algorithms that can predict things like patient drop out.
  • More than one million registered users across 1,600+ customers and partners access the world's most-used platform for clinical development, commercial, and real-world data.

Immutep Announces the Start of an Investigator-Initiated Phase II Study in COVID-19 Patients

Retrieved on: 
Friday, October 23, 2020

Under the Agreement, Immutep will provide efti at no cost to the University Hospital Pilsen which will fund the study.

Key Points: 
  • Under the Agreement, Immutep will provide efti at no cost to the University Hospital Pilsen which will fund the study.
  • The study will be a placebo controlled, 1:1 randomized, double blinded Phase II clinical trial involving up to 110 adult patients hospitalized with COVID-19 at University Hospital Pilsen.
  • Patients will receive subcutaneous injections of efti (10 mg) on days 1, 3 and 7, in addition to standard care.
  • Immutep CEO, Marc Voigt, said: We were delighted to be approached for this study by Dr Marek Nalos and Professor Martin Matejovic.

MiMedx Concludes Enrollment for Phase 3 Plantar Fasciitis Trial

Retrieved on: 
Thursday, September 17, 2020

"Plantar fasciitis is an all-too-common, debilitating and painful foot condition that challenges both patients and clinicians.

Key Points: 
  • "Plantar fasciitis is an all-too-common, debilitating and painful foot condition that challenges both patients and clinicians.
  • Our progress to date is all the more gratifying given the dampening effect of the pandemic on patient enrollment.
  • More than two million people are treated for plantar fasciitis inflammation in the United States annually.
  • This study is a Phase 3, prospective, double-blinded, randomized controlled trial of the micronized dehydrated Human Amnion Chorion Membrane (dHACM) injection as compared to saline placebo injection in the treatment of plantar fasciitis.

Atossa Therapeutics Announces Positive Interim Safety Assessment of First Group of Participants in Clinical Study of AT-301 Nasal Spray Being Developed for COVID-19

Retrieved on: 
Tuesday, September 1, 2020

This first group of 8 participants received a single dose of either AT-301A (placebo) or AT-301B (active drug).

Key Points: 
  • This first group of 8 participants received a single dose of either AT-301A (placebo) or AT-301B (active drug).
  • This blinded, positive assessment by the safety committee allows the study to now enroll the next cohort.
  • This favorable safety review is an important milestone, commented Steven Quay, M.D., Ph.D., Atossas President and CEO.
  • The Phase 1 study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups.

Atossa Therapeutics Announces Enrollment and Dosing Completed in First Group of Healthy Participants in Clinical Study of AT-301 Nasal Spray Being Developed for Treatment of COVID-19

Retrieved on: 
Monday, August 17, 2020

This group of 8 participants received a single dose of either AT-301A (placebo) or AT-301B (active).

Key Points: 
  • This group of 8 participants received a single dose of either AT-301A (placebo) or AT-301B (active).
  • Advancing our COVID-19 drug candidates through clinical studies as quickly as possible is our highest priority, commented Steven Quay, M.D., Ph.D., Atossas President and CEO.
  • We are very encouraged by the high level of interest in this study and the speed at which we enrolled this first group of participants.
  • The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups.