Medical research

Johns Hopkins Reports Promising Clinical Data in COVID-19 ARDS Treated with Cellenkos' Cord Blood T-Regulatory Cells

Tuesday, July 7, 2020 - 4:01am

"We are excited by these early data in very sick patients suffering from COVID-19 ARDS.

Key Points: 
  • "We are excited by these early data in very sick patients suffering from COVID-19 ARDS.
  • "We look forward to evaluating this promising therapy in the FDA-approved randomized, double-blinded, placebo-controlled clinical trial of cryopreserved, allogeneic, off-the-shelf, cord blood derived T-regulatory cells (CK0802) in intubated patients suffering from COVID-19 ARDS.
  • "We are very encouraged by these early clinical observations and remain fully committed to bring forward this promising, potentially life-saving therapy into market.
  • There were a total of 11,565,414 COVID-19 cases confirmed globally with 536,649 deaths (July 6, 2020), according to Johns Hopkins University data .

Kitov Pharma Issues CEO Shareholder Letter Providing Business Update

Thursday, July 2, 2020 - 1:34pm

Importantly, following the recent launch of CONSENSI in the U.S., this drug is expected to begin generating royalty revenue for Kitov this year.

Key Points: 
  • Importantly, following the recent launch of CONSENSI in the U.S., this drug is expected to begin generating royalty revenue for Kitov this year.
  • Our core objective is to become a recognized leader in the oncology field and to make a significant impact on patients lives.
  • We look forward to providing you with further updates on these ongoing activities as events warrant.
  • These Phase 1 results are encouraging and indicate that CM24 at higher doses warrants further evaluation in a larger clinical study.

EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Thursday, July 2, 2020 - 9:00am

We thank the FDA for recognizing the importance of this clinical trial and the quick approval we received.

Key Points: 
  • We thank the FDA for recognizing the importance of this clinical trial and the quick approval we received.
  • To date, several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients.
  • EUSA Pharma has received FDA approval to proceed with a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated ARDS, compared to placebo plus standard of care.
  • 2 IL-6 Signalling Pathway Inactivation With Siltuximab in Patients With COVID-19 Respiratory Failure: an Observational Cohort Study.

Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2

Wednesday, July 1, 2020 - 1:59pm

We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible.

Key Points: 
  • We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible.
  • We look forward to providing further data updates on BNT162b1, said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
  • Phase 1/2 randomized, placebo-controlled, observer-blinded study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1.
  • The BNT162b1 candidate remains under clinical study and is not currently approved for distribution anywhere in the world.

Strongbridge Biopharma plc Announces Last Patient Completes Last Study Visit in the Randomized Withdrawal Phase of the LOGICS Trial Evaluating RECORLEV® (levoketoconazole) for Endogenous Cushing’s Syndrome

Wednesday, July 1, 2020 - 12:30pm

A total of 43 patients completed the randomized withdrawal phase of the study.

Key Points: 
  • A total of 43 patients completed the randomized withdrawal phase of the study.
  • The Phase 3 program for RECORLEV consists of SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushings syndrome.
  • The LOGICS study is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS.
  • The Phase 3 program for RECORLEV consists of SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushings syndrome.

Sinclair Research Announces Successful Validation of GLP Ototoxicity Testing Services

Tuesday, June 30, 2020 - 2:00pm

Sinclair Research, a leading provider of nonclinical contract research services, today announced completion of successful validation of GLP ototoxicity testing services in partnership with Turner Scientific, an industry leader specializing in nonclinical hearing research.

Key Points: 
  • Sinclair Research, a leading provider of nonclinical contract research services, today announced completion of successful validation of GLP ototoxicity testing services in partnership with Turner Scientific, an industry leader specializing in nonclinical hearing research.
  • Sinclairs validated GLP ototoxicity testing services provide drug developers with more research options, Andy Brown, Sinclair Researchs Vice President of Commercial Operations said.
  • As a result of our partnership with Turner Scientific, Sinclair Research is one of the only CROs that can offer GLP auditory safety research services, and we are excited to offer GLP ototoxicity testing along with IND-enabling nonclinical toxicology services at a single-site CRO.
  • These successful validation studies provided accurate, high-confidence data and conclusively demonstrated the high-quality auditory research support that Turner Scientific and Sinclair Research are able to provide drug developers.

Galectin Therapeutics Announces Commencement of Patient Enrollment of the Adaptively-Designed Phase 2b/3 Trial of Belapectin in NASH Cirrhosis

Tuesday, June 30, 2020 - 1:00pm

Belapectin had previously been shown that it could prevent the development of new varices in this patient population in the Phase 2 NASH-CX clinical trial (Gastroenterology 2020;158:13341345 or https://doi.org/10.1053/j.gastro.2019.11.296 ).

Key Points: 
  • Belapectin had previously been shown that it could prevent the development of new varices in this patient population in the Phase 2 NASH-CX clinical trial (Gastroenterology 2020;158:13341345 or https://doi.org/10.1053/j.gastro.2019.11.296 ).
  • The primary endpoint of the trial is to assess the effect of belapectin on the incidence of new varices.
  • The design of the NASH-RX trial optimizes patient enrollment and retention and minimizes the need for invasive tests.
  • Global factors such as coronavirus may limit access to NASH patient populations around the globe and slow trial enrollment and prolong the duration of the trial and significantly impact associated costs.

RedHill Biopharma Receives Approval for COVID-19 Phase 2/3 Study with Opaganib in the UK

Monday, June 29, 2020 - 4:49pm

RedHill has also submitted CTA applications for this study in Russia and Italy and plans to expand the study to additional countries.

Key Points: 
  • RedHill has also submitted CTA applications for this study in Russia and Italy and plans to expand the study to additional countries.
  • We are rapidly advancing our COVID-19 program with opaganib, including the recently initiated Phase 2a study in leading U.S. centers.
  • The study is planned to be conducted in clinical sites across Italy, the UK, Russia and additional countries.
  • In parallel, RedHill has initiated enrollment for a randomized, double-blind, placebo-controlledPhase 2a clinical study with opaganib in the U.S. ( NCT04414618 ).

Medable Partners With Datavant to Simplify Integration of Data Sources for Decentralized Clinical Trials

Monday, June 29, 2020 - 1:08pm

Medable Inc. , the leading software provider for decentralized clinical trials, and Datavant , the leader in helping healthcare organizations safely connect their data, today announced a partnership that will help clinical trial teams easily integrate multiple data sources to accelerate decentralized trial design, recruitment and data management.

Key Points: 
  • Medable Inc. , the leading software provider for decentralized clinical trials, and Datavant , the leader in helping healthcare organizations safely connect their data, today announced a partnership that will help clinical trial teams easily integrate multiple data sources to accelerate decentralized trial design, recruitment and data management.
  • Medable will integrate Datavants technology into Medables decentralized trials platform, allowing trial teams to combine real-world health records, claims, diagnostic and other data sources with their clinical trial data.
  • Datavant provides us with a broad array of built-in connections to real-world data sources, which can now be combined to yield a more holistic view of patient health than clinical trial data alone.
  • By linking real-world data sources with other sources of study data, clinical trial teams will be better equipped to generate and submit real-world evidence for regulatory assessment.

Montreal Heart Institute announces COLCORONA trial in patients with COVID-19 passes futility test in interim analysis

Saturday, June 27, 2020 - 2:54am

MONTREAL, June 26, 2020 (GLOBE NEWSWIRE) -- Montreal Heart Institute today announced that the COLCORONA clinical trial will continue to recruit non-hospitalized adult patients with COVID-19 as recommended by the independent data monitoring committee (DMC), following a futility analysis.

Key Points: 
  • MONTREAL, June 26, 2020 (GLOBE NEWSWIRE) -- Montreal Heart Institute today announced that the COLCORONA clinical trial will continue to recruit non-hospitalized adult patients with COVID-19 as recommended by the independent data monitoring committee (DMC), following a futility analysis.
  • COLCORONA is a contact-free, at-home, randomized, double-blind, placebo-controlled study run out of several regions in Canada, the United States, Europe, South America, and Africa.
  • The Montreal Heart Institute and its partners worldwide would like to thank all the patients and investigators for their continued participation in the COLCORONA study.
  • The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute (MHI).