Publications

Immunomodulation

COVID-19

Bosteels C, Maes B, Van Damme K, De Leeuw E, Declercq J, Delporte A, et al. Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun; 21(1): 491. doi:10.1186/s13063-020-04451-7

Hall MW, Joshi I, Leal L, Ooi EE. Immune modulation in COVID-19: Strategic considerations for personalized therapeutic intervention [published online ahead of print, 2020 Jul 1]. Clin Infect Dis. 2020;ciaa904. doi:10.1093/cid/ciaa904

Lazarus HM, Gale RP. G-CSF and GM-CSF Are Different. Which One Is Better for COVID-19? [published online ahead of print, 2020 Aug 13]. Acta Haelatol. 2020.  doi:10.1159/000510352

Immune Paralysis and Sepsis

Hall MW. Immune Modulation in Pediatric Sepsis. J Pediatr Intensive Care. 2019;8(1):42–50. doi:10.1055/s-0038-1676607

J. J. Presneill, T. Harris, A. G. Stewart, J. F. Cade, J. W. Wilson, A randomized phase II trial of granulocyte-macrophage colony-stimulating factor therapy in severe sepsis with respiratory dysfunction. Am J Respir Crit Care Med 166, 138-143 (2002).

Infection

Damiani G, McCormick TS, Leal LO, Ghannoum MA. Recombinant human granulocyte macrophage-colony stimulating factor expressed in yeast (sargramostim): A potential ally to combat serious infections. Clin Immunol. 2020;210:108292. doi:10.1016/j.clim.2019.108292

Pneumonia and Acute Respiratory Distress Syndrome (ARDS)

B. Rosler, S. Herold, Lung epithelial GM-CSF improves host defense function and epithelial repair in influenza virus pneumonia-a new therapeutic strategy? Mol Cell Pediatr 3, 29 (2016).

S. Herold et al., Inhaled granulocyte/macrophage colony-stimulating factor as treatment of pneumonia-associated acute respiratory distress syndrome. Am J Respir Crit Care Med 189, 609-611 (2014).

E. S. Halstead et al., GM-CSF overexpression after influenza a virus infection prevents mortality and moderates M1-like airway monocyte/macrophage polarization. Respir Res 19, 3 (2018).

T. M. Umstead et al., Lower respiratory tract delivery, airway clearance, and preclinical efficacy of inhaled GM-CSF in a postinfluenza pneumococcal pneumonia model. Am J Physiol Lung Cell Mol Physiol 318, L571-L579 (2020).

F. F. Huang et al., GM-CSF in the lung protects against lethal influenza infection. Am J Respir Crit Care Med 184, 259-268 (2011).

Pulmonary Alveolar Proteinosis

Campo I, Mariani F, Paracchini E, et al. Whole lung lavage followed by inhaled sargramostim as therapy of autoimmune pulmonary alveolar proteinosis [abstract]. Am J Respir Crit Care Med. 2016;193:A6438

R. Tazawa et al., Inhaled granulocyte/macrophage-colony stimulating factor as therapy for pulmonary alveolar proteinosis. Am J Respir Crit Care Med 181, 1345-1354 (2010).

R. Tazawa et al., Inhaled GM-CSF for Pulmonary Alveolar Proteinosis. N Engl J Med 381, 923-932 (2019).

Oncology

Immune Oncology

Hodi FS, Lee S, McDermott DF, et al. Ipilimumab plus sargramostim vs ipilimumab alone for treatment of metastatic melanoma: a randomized clinical trial. JAMA. 2014;312(17):1744–1753. doi:10.1001/jama.2014.13943

Tarhini AA, Joshi I, Garner F. Sargramostim and immune checkpoint inhibitors: combinatorial therapeutic studies in metastatic melanoma. Immunotherapy. 2021 Aug;13(12):1011-1029. doi: 10.2217/imt-2021-0119.

Lazarus HM, Ragsdale CE, et al. Sargramostim (rhu CM-CSF) as Cancer Therapy (Systematic Review) and An Immunomodulator. A Drug Before Its Time? Frontiers in Immunology. 2021;12:3196. https://doi.org/10.3389/fimmu.2021.706186

 

 

Hematology

Nemunaitis J, Rosenfeld CS, Ash R, et al. Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation. Bone Marrow Transplant. 1995;15(6):949–954.

Rowe JM, Andersen JW, Mazza JJ, et al. A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995;86(2):457–462.

Solh M, Solomon SR, Holland HK, Morris LE, Bashey A. A Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post Infusion of T -Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells with Post Transplant Cyclophosphamide. Blood. 2019;134(suppl 1):S4479. doi:10.1182/blood-2019-131624

Central Nervous System

Alzheimer’s disease

Potter, H, Woodcock, JH, Boyd, TD, et al. Safety and efficacy of sargramostim (GM‐CSF) in the treatment of Alzheimer’s disease. Alzheimer’s Dement. 2021; 7:e12158. https://doi.org/10.1002/trc2.12158

Acute Radiation Syndrome

Clayton NP, Charpentier EJJ, LaCasse ER, Khan-Malek RC, Keutzer JM. Sargamostim accelerates leukocyte recovery and improves mortality rate at day 60 in a non-human primate model of hematopoietic acute radiation syndrome when administered 48 h after total body irradiation. Blood. 2016;128:122:2512. doi:10.1182/blood.V128.22.2512.2512

Gale RP, Armitage JO. Use of molecularly-cloned haematopoietic growth factors in persons exposed to acute high-dose, high-dose rate whole-body ionizing radiations [published online ahead of print, 2020 Apr 2]. Blood Rev. 2020;100690. doi:10.1016/j.blre.2020.100690

Note: Not all clinical trials of sargramostim are listed.