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, MA – April 29, 2021 — 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.
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:
- To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
- For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients.
- For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.
- For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.
- For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.
- To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
Important Safety Information for Leukine (sargramostim)
- LEUKINE is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE.
Warnings and Precautions
- Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Permanently discontinue LEUKINE in patients with serious allergic reactions.
- LEUKINE can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
- Do not administer LEUKINE simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
- Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE administration. LEUKINE should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
- Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease.
- If ANC > 20,000 cells/mm3 or if WBC counts > 50,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
- LEUKINE therapy should be discontinued if disease progression is detected during treatment.
- Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration required.
- Liquid solutions containing benzyl alcohol (including LEUKINE Injection) or LEUKINE for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates and low birth weight infants.
- Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE should be avoided.
Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:
- In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
- In Allogeneic BMT patients–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin
- In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema
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