Clinical endpoint

Oncolytics Biotech® and SOLTI Achieve Primary Endpoint in AWARE-1 Study

Retrieved on: 
Monday, April 12, 2021
Oncolytics Biotech, Pelareorep, Health, Medicine, Clinical trials, Medical statistics, Clinical medicine, Clinical endpoint, Endpoint, Tumor-infiltrating lymphocytes

(NASDAQ: ONCY) (TSX: ONC), together with SOLTI, recently announced new clinical data from the AWARE-1 window-of-opportunity breast cancer study showing patients receiving pelareorep plus checkpoint blockade therapymet the trial\'s primary endpoint.

Key Points: 
  • (NASDAQ: ONCY) (TSX: ONC), together with SOLTI, recently announced new clinical data from the AWARE-1 window-of-opportunity breast cancer study showing patients receiving pelareorep plus checkpoint blockade therapymet the trial\'s primary endpoint.
  • "\nMatt Coffey, Ph.D., M.B.A., President and Chief Executive Officer of Oncolytics Biotech Inc. added, "Achieving the primary endpoint in AWARE-1 is a key milestone validating our clinical development strategy.
  • The primary endpoint of the study is overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes).
  • It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time.

Stuart Therapeutics Announces Receipt of Study May Proceed Letter from U.S. FDA for ST-100 Dry Eye Disease Phase 2 Clinical Trial

Retrieved on: 
Friday, April 16, 2021
Clinical research, Health sciences, Medical statistics, Health, Medical research, Clinical trials, Clinical endpoint, Pharmaceutical industry, Drug discovery

Stuart owns the exclusive worldwide rights to PolyCol for ophthalmic therapeutic use.

Key Points: 
  • Stuart owns the exclusive worldwide rights to PolyCol for ophthalmic therapeutic use.
  • The ST-100 Phase 2 trial, expected to begin before the end of the second quarter of this year, is a double-blind, multi-center trial, with two primary, and several secondary endpoints.
  • "Our Phase 2 study design provides us the opportunity to gain important insights about the effectiveness of ST-100 for a wide range of dry eye disease symptoms and signs.
  • "We are looking forward to successful execution of our Phase 2 trial and the ability to help patients that suffer from chronic ocular surface disease.

Zentalis Pharmaceuticals Announces Promising Initial Data Presented in a Late-Breaking Session at AACR on ZN-c3, its WEE1 Inhibitor, in Patients with Advanced Solid Tumors

Retrieved on: 
Saturday, April 10, 2021
Drugs, Health sciences, Health, Orphan drugs, Breakthrough therapy, Clinical endpoint, Clinical research, Evofosfamide

In the Phase 1 dose-escalation trial, ZN-c3 was dosed starting at 25 mg and going as high as 450 mg QD in patients with advanced or metastatic solid tumors.

Key Points: 
  • In the Phase 1 dose-escalation trial, ZN-c3 was dosed starting at 25 mg and going as high as 450 mg QD in patients with advanced or metastatic solid tumors.
  • At the time of the data cutoff on February 12, 2021, 55 patients were evaluated for safety, the primary endpoint.
  • The study remains ongoing and based on the data presented at AACR, ZN-c3 generated 5 Partial Responses.
  • Zentalis is currently conducting a Phase 1/2 clinical trial in patients with advanced solid tumors and reported initial data from the Phase 1 portion at the AACR Annual Meeting 2021.

Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Renal Cell Carcinoma in Japan

Retrieved on: 
Wednesday, March 31, 2021
Cancer treatments, Health sciences, Medicine, Clinical trials, Medical statistics, Medical terminology, Orphan drugs, Antineoplastic drugs, Sunitinib, Clinical endpoint, Progression-free survival, Survival rate

TOKYO, Mar 31, 2021 - (JCN Newswire) - Eisai Co., Ltd. and MSD K.K.

Key Points: 
  • TOKYO, Mar 31, 2021 - (JCN Newswire) - Eisai Co., Ltd. and MSD K.K.
  • This is the first application to be submitted in Japan for this combination therapy.
  • In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) as well as key secondary endpoints of overall survival (OS) and objective response rate (ORR) versus sunitinib.
  • The safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported studies.

Delcath Systems, Inc. Announces Fourth Quarter 2020 Results, Highlights Preliminary Positive FOCUS Trial Results; Conference Call Today at 8:00am Eastern Time

Retrieved on: 
Wednesday, March 31, 2021
Health, Medicine, Cancer, Melanoma, Delcath Systems, Clinical endpoint, Uveal melanoma, Response rate

The company will host its quarterly call at 8:00am ET today, with a primary focus on discussing the preliminary top line data.

Key Points: 
  • The company will host its quarterly call at 8:00am ET today, with a primary focus on discussing the preliminary top line data.
  • During and since the fourth quarter of 2020, the company:
    Reported positive preliminary results from the FOCUS Clinical Trial (NCT02678572) for Patients with Hepatic Dominant Ocular Melanoma treated with HEPZATO based on an analysis of currently evaluable patients.
  • The primary endpoint, overall response rate (ORR), as determined by an independent review committee, exceeded the prespecified threshold for success.
  • The fourth quarter marked the start of a critical transformation for Delcath, said Gerard Michel, CEO of Delcath.

Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19

Retrieved on: 
Monday, March 29, 2021
Infectious diseases, Hospitals, Genetics, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Clinical trials, Clinical research, Medical statistics, Clinical endpoint, Medical research, Health, the Lenzilumab Phase 3 Study, Humanigen, Inc.

The study achieved its primary endpoint of ventilator-free survival measured through day 28 following treatment (HR: 1.54; 95%CI: 1.03-2.33, p=0.0365).

Key Points: 
  • The study achieved its primary endpoint of ventilator-free survival measured through day 28 following treatment (HR: 1.54; 95%CI: 1.03-2.33, p=0.0365).
  • In this study, lenzilumab appeared to be safe and well-tolerated; no new SAEs were identified, and none were attributed to lenzilumab.
  • The dosing regimen used in this study was specifically designed for hospitalized patients with COVID-19 pneumonia as a potential foundational therapy.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment.

Protagonist Announces Plans to Initiate a Global Phase 3 Study for Rusfertide in Polycythemia Vera Following Interactions with the U.S. Food & Drug Administration and the European Medicines Agency

Retrieved on: 
Monday, March 22, 2021
Clinical research, Health sciences, Medical research, Health, Pharmaceutical industry, Medical statistics, Clinical trials, Food and Drug Administration, Inclusion and exclusion criteria, Clinical endpoint

Protagonist has also received written comments from the European Medicines Agency ("EMA") supportive of the Company's pivotal clinical development plan in PV.

Key Points: 
  • Protagonist has also received written comments from the European Medicines Agency ("EMA") supportive of the Company's pivotal clinical development plan in PV.
  • Based on the feedback from the FDA and EMA, Protagonist intends to initiate a global Phase 3 clinical trial of rusfertide in PV.
  • Frequency of phlebotomies, as well as symptom improvement as measured by MPN-TSS criteria, will be among the important secondary endpoints in the study.
  • Importantly, the Phase 3 study will have endpoints and inclusion/exclusion criteria similar to those in the ongoing Phase 2 study.

Invitation to a conference call and webcast in connection with Isofol receiving recommendation to complete the global Phase III AGENT study for market registration as planned with 440 patients

Retrieved on: 
Monday, March 22, 2021
Medicine, Health sciences, Health, Medical terminology, Clinical trials, Medical statistics, Merck Group, Progression-free survival, Clinical endpoint, Tecemotide, Evofosfamide

Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR).

Key Points: 
  • Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR).
  • The key secondary endpoints are progression free survival (PFS) and duration of response (DOR).
  • The drug candidate is currently being studied in a global Phase III study, AGENT.
  • Isofol holds a worldwide exclusive license agreement with Merck KGaA, Darmstadt, Germany to develop and commercialize arfolitixorin for oncology indications.

CureApp and Jichi Medical University Collaborate on a Hypertension Therapeutics App: Primary Endpoint Met in Phase III Clinical Trial in Japan

Retrieved on: 
Thursday, March 18, 2021
Technology, Mobile, Wireless, Clinical trials, Cardiology, Software, Health, University, General Health, Education, Hypertension, Health, Behavior modification, Digital therapeutics, Medicine, Antihypertensive drug, Clinical endpoint, Essential hypertension

Results of this study showed a statistically significant difference in average systolic blood pressure*1 over a 24-hour period the primary endpoint of this study, demonstrating a hypotensive effect.

Key Points: 
  • Results of this study showed a statistically significant difference in average systolic blood pressure*1 over a 24-hour period the primary endpoint of this study, demonstrating a hypotensive effect.
  • View the full release here: https://www.businesswire.com/news/home/20210318005504/en/
    CureApp and Jichi Medical University collaborate on a hypertension therapeutics app: Primary endpoint met in Phase III clinical trial in Japan (Graphic: Business Wire)
    Commencing in December 2019, this trial*2 evaluated the efficacy and safety of the DTx app when used with patients with essential hypertension who had not received oral treatments using antihypertensive drugs.
  • In Japan, hypertension is found in some 43 million people*3, and medical costs associated with hypertension have ballooned to around 1.7 trillion yen*6.
  • A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB-DH1 trial.

VASCEPA® (Icosapent Ethyl) Found in Prespecified and Post Hoc Analyses to Significantly Reduce Stroke in At-Risk Patients in Analyses of Landmark REDUCE-IT® Study Presented at International Stroke Conference 2021

Retrieved on: 
Wednesday, March 17, 2021
Clinical trials, Stroke, Clinical endpoint, Health

Ischemic stroke time to first event rates were 2.0% for VASCEPA vs. 3.0% for placebo for a RRR of 36% (p=0.002).

Key Points: 
  • Ischemic stroke time to first event rates were 2.0% for VASCEPA vs. 3.0% for placebo for a RRR of 36% (p=0.002).
  • Hemorrhagic stroke occurred at low rates with no significant difference for VASCEPA vs. placebo (0.3% vs 0.2%; p=0.55).
  • Stroke is a major and often debilitating cardiovascular event significantly impacting not only patients and their loved ones, but also the healthcare system.
  • Stroke was a prespecified secondary endpoint within the testing hierarchy; ischemic stroke was a prespecified tertiary endpoint; stroke subgroup analyses were post hoc.