Clinical endpoint

Aprea Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Update on Business Operations

Retrieved on: 
Tuesday, March 16, 2021
Clinical endpoint, Clinical research

The Company is completing analysis from this Phase 3 clinical trial and expects to present additional information in the second quarter of 2021.

Key Points: 
  • The Company is completing analysis from this Phase 3 clinical trial and expects to present additional information in the second quarter of 2021.
  • The Company anticipates initial results from the primary endpoint of relapse-free survival at 12 months in the second quarter of 2021.
  • Research and Development (R&D) expenses:R&D expenses were$9.3 millionfor the quarter endedDecember 31, 2020, compared to$8.0 millionfor the comparable period in 2019.
  • General and Administrative (G&A) expenses:G&A expenses were$4.9 millionfor the quarter endedDecember 31, 2020, compared to$3.9 millionfor the comparable period in 2019.

Atara Biotherapeutics Presents New Long-Term Overall Survival Data from a Combined Analysis of Phase 2 Tab-cel® Studies for Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative Disease at The EBMT 2021 Annual Meeting

Retrieved on: 
Sunday, March 14, 2021
Biotechnology, Hospitals, Health, Pharmaceutical, Clinical trials, Health, Drugs, Orphan drugs, Clinical endpoint, Clinical research, Rituximab

Treatment response and OS data were assessed from two completed single-arm, Phase 2 studies ( NCT00002663 , NCT01498484 ) and the multicenter expanded access protocol (EAP-201) study ( NCT02822495 ).

Key Points: 
  • Treatment response and OS data were assessed from two completed single-arm, Phase 2 studies ( NCT00002663 , NCT01498484 ) and the multicenter expanded access protocol (EAP-201) study ( NCT02822495 ).
  • Data from across three clinical studies suggest that tab-cel may provide an effective treatment option marked by long-term overall survival regardless of partial or complete response.
  • This data set included 50 HCT recipients who developed EBV+ PTLD R/R to rituximab that were treated with tab-cel.
  • Objective response rate (PR + CR) was 62 percent (31/50) with best overall response (BOR) of CR (n=24) or PR (n=7).

Landmark Long-Term Data from EORTC’s MINDACT Study Published in The Lancet Oncology

Retrieved on: 
Friday, March 12, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, MammaPrint, Microarrays, Clinical trials, Medical statistics, Health, American Society of Clinical Oncology, Clinical endpoint, Oncology, Medical research, The Lancet, Asco, Agendia, the MINDACT Trial

With 5-year data available for 92 percent of enrolled patients, the studys primary endpoint continued to be met.

Key Points: 
  • With 5-year data available for 92 percent of enrolled patients, the studys primary endpoint continued to be met.
  • We are immensely proud of these results being published in The Lancet Oncology the longer term follow up clearly shows the utility that MammaPrint provides to clinicians and their patients.
  • The study found that clinically high-risk patients with a MammaPrint Low Risk result could safely de-escalate treatment and forgo chemotherapy.
  • Long-term follow-up data from MINDACT, presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO), confirmed and built upon the findings published in the New England Journal of Medicine in 2016.

Ministry of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Anti-Cancer Agent Lenvima (Lenvatinib) With Prospective Indication for Uterine Body Cancer

Retrieved on: 
Friday, March 12, 2021
Drugs, Orphan drugs, Cancer treatments, Health sciences, Chloroarenes, Ureas, Eisai, Lenvatinib, Protein kinase inhibitor, Progression-free survival, Pembrolizumab, Clinical endpoint

TOKYO, Mar 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received orphan drug designation for LENVIMA (generic name: lenvatinib mesylate), the orally available multiple receptor kinase inhibitor discovered by Eisai, with a prospective indication for uterine body cancer, by the Ministry of Health, Labour and Welfare (MHLW).

Key Points: 
  • TOKYO, Mar 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received orphan drug designation for LENVIMA (generic name: lenvatinib mesylate), the orally available multiple receptor kinase inhibitor discovered by Eisai, with a prospective indication for uterine body cancer, by the Ministry of Health, Labour and Welfare (MHLW).
  • In this study, LENVIMA plus KEYTRUDA met its dual primary endpoints, overall survival (OS) and progression-free survival (PFS), as well as its secondary efficacy endpoint of objective response rate (ORR).
  • Currently, Eisai is preparing to submit an application for additional indications based on these results in various countries around the world including Japan.
  • Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer.

Sequana Medical Notice of 2020 Full Year Results and Business Update

Retrieved on: 
Wednesday, March 10, 2021
Communication, Forward-looking statement, Clinical research, Medical statistics, Clinical trials, Sequana, Clinical endpoint, Articles

Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study.

Key Points: 
  • Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study.
  • Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure.
  • These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Sequana Medical Notice of 2020 Full Year Results and Business Update

Retrieved on: 
Wednesday, March 10, 2021
Communication, Forward-looking statement, Clinical research, Medical statistics, Clinical trials, Sequana, Clinical endpoint, Articles

Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study.

Key Points: 
  • Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study.
  • Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure.
  • These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Graybug Vision Reports Preliminary Topline Results from Phase 2b ALTISSIMO Trial

Retrieved on: 
Tuesday, March 9, 2021
Breakthrough therapy, Clinical trials, Health sciences, Aflibercept, Sanofi, Clinical endpoint, Health, Altissimo, Medical research

The ALTISSIMO trial is a masked and controlled Phase 2b dose-ranging study of two doses of GB-102 with a single control arm of patients on aflibercept, conducted across 33 study sites in the United States.

Key Points: 
  • The ALTISSIMO trial is a masked and controlled Phase 2b dose-ranging study of two doses of GB-102 with a single control arm of patients on aflibercept, conducted across 33 study sites in the United States.
  • Analysis of the ALTISSIMO 1mg arm shows the primary endpoint of median time to first supportive therapy was 5 months.
  • Graybug will determine next steps after completing the full analysis of the ALTISSIMO results, which is anticipated to occur in the second quarter.
  • We are very grateful to all patients, investigators and staff who participated in the ALTISSIMO trial, and look forward to the read-out of the extension trial data, said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug.

AnaptysBio Reports Imsidolimab POPLAR Phase 2 Clinical Trial in Moderate-to-Severe Palmoplantar Pustulosis (PPP) Did Not Meet Primary Endpoint

Retrieved on: 
Monday, March 8, 2021
Clinical research, Clinical trials, Health, Medical statistics, Deception, Placebo, Clinical endpoint, Medicine

The most common adverse events observed in the imsidolimab and placebo arms were three and four cases of mild nasopharyngitis, respectively, that were each deemed treatment unrelated.

Key Points: 
  • The most common adverse events observed in the imsidolimab and placebo arms were three and four cases of mild nasopharyngitis, respectively, that were each deemed treatment unrelated.
  • Fifty-nine PPP patients were enrolled in this trial at 36 sites located within North America and Europe.
  • Patients were washed out of prior PPP therapy and no concomitant therapy was permitted during the trial.
  • The primary endpoint of this trial was mean change in PPPASI at week 16 relative to baseline and the estimator for between-group comparison was LSMD.

CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19

Retrieved on: 
Monday, March 8, 2021
Clinical trials, Health, Leronlimab, Medical statistics, Clinical endpoint, Coronavirus disease, Articles

MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial.

Key Points: 
  • MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial.
  • The Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled.
  • These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada.
  • 3) Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant.

CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19

Retrieved on: 
Sunday, March 7, 2021
Clinical trials, Health, Leronlimab, Medical statistics, Clinical endpoint, Coronavirus disease, Articles

MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial.

Key Points: 
  • MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial.
  • The Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled.
  • These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada.
  • 3) Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant.