- |||||||||| rheumatoid arthritis vaccine (CEL-4000) - CEL / SCI
Review, Journal: Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines. (Pubmed Central) - Mar 25, 2024
Unlike these treatments, a therapeutic vaccine, such as CEL-4000, helps balance adaptive immune homeostasis by promoting antigen-specific regulatory rather than inflammatory responses, and hence modulates the immunopathological course of RA...Human trials of such a therapy will require alternative approaches in clinical trial design and implementation for determining safety, toxicity, and efficacy. These approaches include adaptive design (such as the Bayesian optimal design (BOIN), currently employed in oncological clinical studies), and the use of disease-related biomarkers as indicators of treatment success.
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Tumor node stage shift following leukocyte interleukin injection neoadjuvant extends overall survival in treatment-na () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2439;
P3
These approaches include adaptive design (such as the Bayesian optimal design (BOIN), currently employed in oncological clinical studies), and the use of disease-related biomarkers as indicators of treatment success. Background A 3-week pre-surgery peri-tumoral/peri-lymphatic administration of a pro-inflammatory cytokine complex biologic (LI) with CIZ (single low dose cyclophosphamide IV, 300 mg/m2), indomethacin (po 25mg tid) and yinc multivitamins (po 15-45mg yinc) + Standard of Care (SOC) to treatment-na
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Histopathology (HP) biomarkers confirm leukocyte interleukin injection (LI) treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN) the IT-MATTERS study (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2086;
P3
Broad demonstration beyond 2.5% chance always favored LI+CIZ+SOC vs SOC (see below). Table: 128P All advantages favored LI+CIZ+SOC vs SOC (only seen in LR) Conclusions Efficacy (OS, PFS, LRC) was seen for multiple biomarkers (tumor: p16, PDL1, TME: CD4, CD8, CD3, FOXP3, CD20, CD68, CD163, CD1A, immune cells: PD1, CTLA4, PDL1, and CD25), ratios (CD4/CD8, CD8/FOXP3), and pre-defined combinations confirm and support LI OS efficacy.
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Brain metastasis mouse models for the evaluation of multikine inhibitors on ROS1-fusion-positive lung cancer (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_7625;
In summary, we established brain metastases lung cancer PDX models as reliable platforms for interrogation of targets and kinetics related mechanism and for drug screening. The use of such techniques will increase our knowledge of the metastatic process and help identify new targets of cancer metastasis.
- |||||||||| rheumatoid arthritis vaccine (CEL-4000) - CEL / SCI
Preclinical, Journal: Vaccination by Two DerG LEAPS Conjugates Incorporating Distinct Proteoglycan (PG, Aggrecan) Epitopes Provides Therapy by Different Immune Mechanisms in a Mouse Model of Rheumatoid Arthritis. (Pubmed Central) - Jun 3, 2021
LEAPS (Ligand Epitope Antigen Presentation System) DerG peptide conjugate vaccines were prepared using epitopes from PG that elicit immune responses in RA patients: epitope PG70 (DerG-PG70, also designated CEL-4000) and the citrullinated form of another epitope (PG275Cit)...Similarly, cytokines secreted by CD4+ cells of unvaccinated GIA mice, differentiated in vitro to Th2 cells and treated with either or both DerG vaccine peptides, exhibited an anti-inflammatory (IL-4, IL-10) profile. These results suggest that the two peptides elicit different therapeutic immune responses by the immunomodulation of disease-promoting pro-inflammatory responses and that the combination of the two LEAPS conjugates may provide broader epitope coverage and, in some cases, greater efficacy than either conjugate alone.
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Trial completion date, Surgery, Metastases: IT-MATTERS: Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (clinicaltrials.gov) - Mar 18, 2021
P3, N=928, Active, not recruiting,
These results suggest that the two peptides elicit different therapeutic immune responses by the immunomodulation of disease-promoting pro-inflammatory responses and that the combination of the two LEAPS conjugates may provide broader epitope coverage and, in some cases, greater efficacy than either conjugate alone. Trial completion date: May 2020 --> Apr 2021
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Trial completion date, Trial primary completion date, Surgery, Metastases: IT-MATTERS: Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (clinicaltrials.gov) - Feb 25, 2020
P3, N=928, Active, not recruiting,
Trial completion date: May 2020 --> Apr 2021 Trial completion date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2019 --> Mar 2020
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Trial completion date, Trial primary completion date, Surgery, Metastases: IT-MATTERS: Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (clinicaltrials.gov) - Oct 1, 2019
P3, N=928, Active, not recruiting,
Trial completion date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2019 --> Mar 2020 Trial completion date: Sep 2019 --> Dec 2019 | Trial primary completion date: Sep 2019 --> Dec 2019
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Ergomed, Orient Europharma
Multikine (Twitter) - Mar 28, 2019
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Trial completion date, Trial primary completion date, Surgery, Metastases: IT-MATTERS: Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (clinicaltrials.gov) - Mar 4, 2019
P3, N=928, Active, not recruiting,
Trial completion date: Sep 2019 --> Dec 2019 | Trial primary completion date: Sep 2019 --> Dec 2019 Trial completion date: Dec 2020 --> Sep 2019 | Trial primary completion date: Dec 2020 --> Sep 2019
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Enrollment closed, Trial completion date, Trial primary completion date, Surgery, Metastases: IT-MATTERS: Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (clinicaltrials.gov) - Feb 28, 2019
P3, N=928, Active, not recruiting,
Trial completion date: Dec 2020 --> Sep 2019 | Trial primary completion date: Dec 2020 --> Sep 2019 Completed --> Active, not recruiting | Trial completion date: Dec 2017 --> Dec 2020 | Trial primary completion date: Dec 2017 --> Dec 2020
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Trial termination: Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts (clinicaltrials.gov) - Feb 11, 2019
P1, N=8, Terminated,
Completed --> Active, not recruiting | Trial completion date: Dec 2017 --> Dec 2020 | Trial primary completion date: Dec 2017 --> Dec 2020 Active, not recruiting --> Terminated; Insufficient enrollment
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Enrollment closed, Enrollment change: Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts (clinicaltrials.gov) - Feb 27, 2018
P1, N=8, Active, not recruiting,
Active, not recruiting --> Terminated; Insufficient enrollment Recruiting --> Active, not recruiting | N=15 --> 8
- |||||||||| Multikine (leukocyte interleukin injection) - CEL / SCI, Orient Europharma
Enrollment change, Trial termination, Trial primary completion date: Safety Study of Multikine in the Treatment of Perianal Warts (clinicaltrials.gov) - Aug 19, 2016
P1, N=4, Terminated,
Trial primary completion date: Jun 2017 --> Jun 2018 N=15 --> 4 | Recruiting --> Terminated | Trial primary completion date: Jul 2015 --> Jan 2016; Unable to enroll prospective subject for dose escalation
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