- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Trial completion, Metastases: Pembrolizumab and GM-CSF in Biliary Cancer (clinicaltrials.gov) - Jan 12, 2022 P2, N=42, Completed, Adjuvant IFN led to durable TFRs with limited prior TKI exposure with comparable success to prior discontinuation trials, but many patients stopped IFN early. Active, not recruiting --> Completed
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen
Journal: Radiation countermeasures for hematopoietic acute radiation syndrome: Growth factors, cytokines and beyond. (Pubmed Central) - Jan 5, 2022 It is critical that additional agents for other major sub-syndromes of ARS (gastrointestinal-ARS) be approved. Future success in developing such medicinals will undoubtedly entail some form of a polypharmaceutical strategy, or perhaps novel, bioengineered chimeric agents with multiple, radioprotective/radiomitigative functionalities.
- |||||||||| Leukine (sargramostim) / Partner Therap, Panvac-VF (falimarev/inalimarev) / Bavarian Nordic
Trial completion date, Trial primary completion date, Surgery: Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov) - Jan 5, 2022 P1, N=18, Active, not recruiting, Future success in developing such medicinals will undoubtedly entail some form of a polypharmaceutical strategy, or perhaps novel, bioengineered chimeric agents with multiple, radioprotective/radiomitigative functionalities. Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Dec 2021 --> Apr 2022
- |||||||||| Leukine (sargramostim) / Partner Therap
Enrollment closed: Sargramostim Use in COVID-19 to Recover Patient Health (clinicaltrials.gov) - Dec 3, 2021 P2b, N=500, Active, not recruiting, Conclusions Activation of inflammation and the innate immune system in AD may provide therapeutic benefit. Recruiting --> Active, not recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion: A Phase II/III Study of Sargramostim (clinicaltrials.gov) - Nov 3, 2021 P2/3, N=70, Completed, Trial completion date: Nov 2021 --> Nov 2022 | Trial primary completion date: Nov 2021 --> Nov 2022 Recruiting --> Completed
- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp
SUCCESSFUL SUBCUTANEOUS SARGRAMOSTIM DESENSITIZATION (Hall B (1st Floor); Monitor 01) - Nov 2, 2021 - Abstract #ACAAI2021ACAAI_700; While most desensitization protocols are performed intravenously, this case highlights a successful subcutaneous protocol to GM-CSF. This protocol may be considered in patients who have repeated hypersensitivity reactions to intravenous desensitization.
- |||||||||| Leukine (sargramostim) / Partner Therap, Herceptin (trastuzumab) / Roche, GP2 / Greenwich LifeSci
Analysis of GP2 immune response and relationship to recurrence in a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 (GLSI-100) vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1548; P2 It is theorized that a positive baseline DTH skin test to GP2 may be evidence of an existing immune response to GP2 associated with residual disease, impending recurrence, or prior treatments. Further studies assessing if GP2 immune response is an important prognosticator of cancer disease state or recurrence are planned.
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion, Trial completion date: Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401) (clinicaltrials.gov) - Oct 25, 2021 P2, N=203, Completed, Further studies assessing if GP2 immune response is an important prognosticator of cancer disease state or recurrence are planned. Active, not recruiting --> Completed | Trial completion date: Aug 2022 --> Jun 2021
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date: Sargramostim Use in COVID-19 to Recover Patient Health (clinicaltrials.gov) - Oct 21, 2021 P2b, N=500, Recruiting, This may have translated into clinical benefit, encouraging the combination of UV1 vaccination with standard of care treatment regimes containing ipilimumab/CTLA-4 blocking antibodies. Trial completion date: Oct 2021 --> Jan 2022
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Preclinical, Journal, Combination therapy: PEG-G-CSF and L-Citrulline Combination Therapy for Mitigating Skin Wound Combined Radiation Injury in a Mouse Model. (Pubmed Central) - Oct 15, 2021 Treatment with l-citrulline alone also accelerated skin wound healing after RCI. In conclusion, these data indicate that the PEG-G-CSF and l-citrulline combination therapy is a potentially effective countermeasure for mitigating RCI, likely by enhancing survival of the hematopoietic stem/progenitor cells and accelerating recovery from the RCI-induced intestinal injury and skin wounds.
- |||||||||| Neupogen (filgrastim) / Kyowa Kirin, Amgen, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
Journal: Celebrating 60 Years of Accomplishments of the Armed Forces Radiobiology Research Institute1. (Pubmed Central) - Oct 1, 2021 These research areas are bolstered by an educational component to broadcast and increase awareness of the medical effects of ionizing radiation, in the mass-casualty scenario after a nuclear detonation or radiological accidents. This work provides a description of the military medical operations as well as the radiation facilities and capabilities present at AFRRI, followed by a review and discussion of each of the research areas.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Enrollment open, Metastases: Sargramostim (GM-CSF) + PD-1 (clinicaltrials.gov) - Sep 16, 2021 P2, N=30, Recruiting, It also may be useful as an adjuvant in anti-cancer immunotherapy. Not yet recruiting --> Recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Review, Journal: Use of molecularly-cloned haematopoietic growth factors in persons exposed to acute high-dose, high-dose rate whole-body ionizing radiations. (Pubmed Central) - Sep 5, 2021 In several experimental models including non-human primate radiation exposure models giving molecularly cloned haematopoietic growth factor including granulocyte/macrophage colony-stimulating factor (G/M-CSF; sargramostim) and granulocyte colony-stimulating factor (G-CSF; filgrastim and pegylated G-CSF [peg-filgrastim]) accelerates bone marrow recovery and increases survival...We discuss the immediate medical response to these events including how to estimate radiation dose and uniformity and which interventions are appropriate in different radiation exposures settings. We also discuss similarities and differences between molecularly cloned haematopoietic growth factors.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), SurVaxM (SVN53-67/M57-KLH peptide vaccine) / MimiVax
Trial completion date, Trial primary completion date: RESURGe: Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence (clinicaltrials.gov) - Aug 24, 2021 P2, N=40, Active, not recruiting, We also discuss similarities and differences between molecularly cloned haematopoietic growth factors. Trial completion date: May 2021 --> May 2024 | Trial primary completion date: May 2021 --> May 2024
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap, Yervoy (ipilimumab) / BMS
Trial initiation date, Metastases: ABSCOPAL 5001: A Phase 2 Trial for Patients With Metastatic Solid Cancer (clinicaltrials.gov) - Aug 18, 2021 P2, N=32, Recruiting, Initiation date: Jun 2021 --> Sep 2021 Initiation date: Jan 2021 --> May 2021
- |||||||||| Leukine (sargramostim) / Partner Therap, Danyelza (naxitamab) - Y / mAbs Therap
Trial completion date, Trial primary completion date: Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov) - Aug 18, 2021 P2, N=48, Active, not recruiting, Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2023 Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion: Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov) - Aug 17, 2021 P3, N=105, Completed, We also review a new approach for IFI after HCT utilizing adjunctive therapy with sargramostim, a yeast-derived recombinant human granulocyte macrophage colony stimulating factor (rhu GM-CSF). Active, not recruiting --> Completed
- |||||||||| Leukine (sargramostim) / Partner Therap
Recruiting the Innate Immune System to Treat Mild-to-Moderate Alzheimer’s Disease: Short-Term, Double-Blind, PlaceboControlled Phase II Trial Shows that GM-CSF/Sargramostim Treatment Leads to Improvements in MMSE and Blood Biomarkers of Neuropathology/Neurodegeneration (Aβ, Tau, and UCH-L1) () - Aug 7, 2021 - Abstract #CTAD2021CTAD_67; P2 One measure of cognition (MMSE), and all three Amyloid, Tau, Neurodegeneration (ATN) plasma measures of neuropathology and neurodegeneration (i.e., Ab, total Tau, and UCHL-1) improved towards normal after three weeks (15 injections) of sargramostim treatment compared to baseline and compared to placebo. These results indicate that modulating the innate immune system using the classically described proinflammatory cytokine, GM-CSF/sargramostim, shows promise as a potentially safe treatment for AD.
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion, Trial completion date, Trial primary completion date: Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis (clinicaltrials.gov) - Aug 3, 2021 P1, N=10, Completed, These results indicate that modulating the innate immune system using the classically described proinflammatory cytokine, GM-CSF/sargramostim, shows promise as a potentially safe treatment for AD. Recruiting --> Completed | Trial completion date: Dec 2021 --> Jun 2021 | Trial primary completion date: Dec 2021 --> Jun 2021
- |||||||||| Leukine (sargramostim) / Sanofi
Inflammation and Innate Immune System Activation in Neurodegeneration, Down Syndrome, Aging, and Infection: Therapeutic Target or Partner? (Convention Ctr - Exhibit Hall F) - Aug 2, 2021 - Abstract #AAIC2021AAIC_1922; Together, these results indicate that targeted enhancement of the innate immune system and of inflammatory cytokines, specifically in response to GM-CSF, can effectively treat many disorders that exhibit characteristic inflammation and innate immune system activation. Thus, the long-held belief that inflammation and innate immune system activation only play a negative role in neurodegenerative diseases, DS, viral infections, and normal aging should be reassessed.
- |||||||||| Leukine (sargramostim) / Sanofi
[VIRTUAL] Inflammation and Innate Immune System Activation in Neurodegeneration, Down Syndrome, Aging, and Infection: Therapeutic Target or Partner? () - Aug 2, 2021 - Abstract #AAIC2021AAIC_1898; Together, these results indicate that targeted enhancement of the innate immune system and of inflammatory cytokines, specifically in response to GM-CSF, can effectively treat many disorders that exhibit characteristic inflammation and innate immune system activation. Thus, the long-held belief that inflammation and innate immune system activation only play a negative role in neurodegenerative diseases, DS, viral infections, and normal aging should be reassessed.
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