I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Reports Assessment of Narsoplimab for Treatment of Critically Ill Patients With COVID-19
Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, and Omeros Corporation (NASDAQ: OMER), developer of the investigational agent narsoplimab, announced that enrollment has been closed and data have been analyzed in the narsoplimab arm of the I-SPY COVID Trial.
ALX Oncology and Quantum Leap Healthcare Collaborative™ Announce the Selection of Evorpacept in the I-SPY-P1 TRIAL in Combination with Enhertu® in Breast Cancer
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative™ (“Quantum Leap”) today announced that ALX Oncology’s next generation CD47 blocker, evorpacept, has been selected for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.
UCSF and I-SPY 2 Breast Cancer Researchers Develop Newly Redefined Breast Cancer Response Subtypes
Research scientists and statisticians from UC San Francisco have developed improved biomarker classifications as part of their research results in the I-SPY 2 trial for high-risk breast cancer patients. The new cancer response subtypes reflect responsiveness to drug treatments and are intended to help clinicians be more precise in how they target therapies.
NEJM Authors’ Perspective cites FDA collaboration with OneSource in discussion about Real World Evidence
More than 5 years after the passage of the 21st Century Cures Act of 2016, the terms “real-world data” (RWD) and “real-world evidence” (RWE) are being used inconsistently and sometimes interchangeably. This imprecision has complicated efforts to assess the impact of such data and evidence and hindered attempts to track their use.
Quantum Leap Healthcare Collaborative™ Announces OneSource as a Grand Prize Winner in the 2022 Bio-IT World Innovative Practices Awards
Quantum Leap Healthcare Collaborative™ (QLHC) announces the award of OneSource, Quantum Leap Healthcare Collaborative’s groundbreaking clinical trial data management solution developed in collaboration with OpenClinica as the grand prize winner at the 2022 Bio-IT World Innovative Practices award in the Clinical & Health-IT category. By integrating clinical trial data systems directly with existing electronic health records, OneSource achieves new levels of efficiency and quality control for clinical trial data management.
Natera to Present Data from the BEATRICE and I-SPY2 Trials in Early-Stage TNBC and HR+/HER2- Breast Cancer at the 2022 AACR Annual Meeting
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it will present new data relating to its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the annual meeting of the American Association for Cancer Research taking place April 8 – 13, 2022.
OneSource Named a 2022 Innovative Practices Award Winner by Bio-IT World
Bio-ITWorld today announced the 2022 Innovative Practices Awards winners. Four grand prize awards were granted to AstraZeneca, Guardant Health with IQVIA, Merck KGaA, Darmstadt, Germany, with Genedata, and Quantum Leap Healthcare Collaborative / University of California San Francisco with OpenClinica. The awards ceremony will be held during the plenary program on Tuesday, May 3, at the 2022 Bio-IT World Conference & Expo in Boston.
UCSF, QLHC and FDA Announce Successful Deployment of Innovative Data Capture System for Clinical Care and Research
UC San Francisco (UCSF), in collaboration with the Quantum Leap Healthcare Collaborative (QLHC) and the U.S. Food and Drug Administration (FDA), has developed the OneSource system to seamlessly integrate clinical care and research data.
OneSource is an electronic data capture (EDC) system which was developed with the goal of radically streamlining the collection and distribution of patient health data for clinical trials. It is based on best practices and open-source data Electronic Health Record (EHR) integration standards to launch seamlessly within widely used EHR platforms.
I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Suggests No Clinical Benefit with Addition of Nebulized ZYESAMI When Given by Mouth in Critically Ill Patients with COVID-19
Quantum Leap Healthcare Collaborative (QLHC) announced in collaboration with NRx Pharmaceuticals, Inc. (NRx), that the nebulized form of ZYESAMI® (Aviptadil), in the I-SPY COVID Trial of Critical COVID-19 patients has been stopped. The I-SPY COVID Trial, (NCT04488081) is a phase 2, open label, adaptive platform trial designed to rapidly screen potential agents that could substantially improve treatment for severely and critically ill COVID-19 patients. QLHC is the sponsor of the I-SPY COVID TRIAL.
No Clinical Benefit Suggested by Addition of Pulmozyme® to Treatment of Critically Ill Patients With COVID-19 in I-SPY COVID Trial
Today Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, announced that the Pulmozyme® (dornase alfa) arm of the trial has been terminated. The interim analysis suggests that the addition of Pulmozyme® to treatment of critically ill patients with COVID-19 is unlikely to achieve statistically significant improvement in efficacy.
