Focus on non-hospitalized patients based on prior data supporting Leukine’s role in improving lung function and enhanced COVID-19 specific immune response
LEXINGTON, Mass., April 29, 2021 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx). , a commercial biotechnology company, announced today that the first patient has been enrolled in the SCOPE clinical trial, a randomized, placebo-controlled, double-blind phase 2 study of inhaled Leukine (sargramostim, rhu-GM-CSF) in 400 non-hospitalized COVID-19 patients (NCT04707664) at higher risk for progression to more severe COVID-19. This study will evaluate the role of Leukine in reducing progression and need for hospitalization in COVID-19 patients. Primary study endpoints are: COVID-19-related emergency room visit, COVID-19- related hospitalization, or death. Sites in the United States and Latin and South America are expected to join the SCOPE study with expansion to additional countries under consideration. “Prior research in patients with acute respiratory distress syndrome has shown that Leukine is safe and associated with a trend toward a reduction in mortality. These findings provide strong support for clinical research to assess the efficacy of Leukine in the treatment of indivduals with COVID-19 infection,” stated Dr. Robert Paine, Chief of the Division of Pulmonary Medicine and Critical Care Medicine at the University of Utah and the prinicipal investigator for the SCOPE trial. He added, “I believe that administering Leukine by inhalation as early as possible in the course of the illness has important potential to reduce progression, reduce the need for invasive procedures such as mechanical ventilation, and hasten recovery.” Initiation of the SCOPE trial follows positive topline results reported from the SARPAC study (NCT04326920), which showed that administration of inhaled Leukine significantly improved lung function, as measured by oxygenation, in hospitalized COVID-19 patients receiving oxygen. This study also confirmed Leukine safety in these patients and demonstrated significantly higher COVID-19 specific immune response in patients receiving Leukine. These findings prompted the SCOPE trial to assess whether Leukine can bolster patients’ antiviral immune responses, as well as prevent disease progression to hospitalization and severe lung impairment. A second study evaulating Leukine’s efficacy in hospitalized COVID-19 patients requiring oxygen was initiated in August 2020 and completed enrollment in mid-February. Results from this study, iLeukPulm (NCT04411680), are expected in the coming weeks. The SCOPE and iLeukPulm studies are supported by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), as part of a $35 million agreement for advanced development and submission of an emergency use authorization request for Leukine as a COVID-19 treatment. The study is being conducted in collaboration with the clinical research organization, FHI Clinical. ABOUT LEUKINE LEUKINE® (sargramostim) is an FDA-approved, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF). GM-CSF is a naturally occurring cytokine protein called a cytokine that plays an important role in myeloid hematopoiesis, immunomodulation, and cell reprogramming. Leukine is designated an Essential Medicine by FDA and is held by the U.S. Government in the Strategic National Stockpile. Leukine is available outside of the United States through a Named Patient Program administered by Tanner Pharma Group. Leukine is indicated:
Important Safety Information for Leukine (sargramostim) Contraindications
Warnings and Precautions
Adverse Reactions Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:
ABOUT PARTNER THERAPEUTICS PTx, an integrated biotechnology company, focuses on development and commercialization of late-stage therapeutics to improve health outcomes in treatment of cancer and other serious diseases. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. Visit www.partnertx.com View original content to download multimedia:http://www.prnewswire.com/news-releases/partner-therapeutics-initiates-patient-enrollment-in-clinical-trial-evaluating-leukine-rhugm-csf-sargramostim-in-high-risk-non-hospitalized-covid-19-patients-scope-301280272.html SOURCE Partner Therapeutics, Inc. |