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  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Cdactin-O (CBM588) / Osel, Miyarisan
    Journal:  The Role of Tumor and Host Microbiome on Immunotherapy Response in Urologic Cancers. (Pubmed Central) -  Jun 7, 2024   
    Specific bacterial taxa, such as Streptococcus salivarius, have been linked with response to pembrolizumab in metastatic castrate-resistant prostate cancer...Although the exact mechanism is unclear, several studies identify a symbiotic relationship between microbiota-centered interventions and immunotherapy efficacy. It is possible to improve immunotherapy responsiveness in genitourinary malignancies using the microbiome, but further research with more standardized methodology is warranted.
  • ||||||||||  Cdactin-O (CBM588) / Osel, Miyarisan
    Journal:  Clostridium butyricum Bacteremia Associated with Probiotic Use, Japan. (Pubmed Central) -  Mar 25, 2024   
    Clostridium butyricum, a probiotic commonly prescribed in Asia, most notably as MIYA-BM (Miyarisan Pharmaceutical Co., Ltd.; https://www.miyarisan.com), occasionally leads to bacteremia...Sequencing results confirmed that all identified C. butyricum bacteremia strains were probiotic derivatives. Our findings underscore the risk for bacteremia resulting from probiotic use, especially in hospitalized patients, necessitating judicious prescription practices.
  • ||||||||||  Cdactin-O (CBM588) / Osel, Miyarisan
    Journal, PD(L)-1 Biomarker, IO biomarker:  The biotherapeutic Clostridium butyricum MIYAIRI 588 strain potentiates enterotropism of Ror?t+Treg and PD-1 blockade efficacy. (Pubmed Central) -  Feb 26, 2024   
    Conversely, blockade of interleukin-10 signaling preferentially enhanced the capacity of CD8+ T cells to secrete Interferon gamma when being cocultured with CBM588-primed lamina propria mononuclear cells of tumor-bearing mice. Our results demonstrate that CBM588-centered intervention can adequately improve intestinal homeostasis and efficiently overcome resistance to PD-1 blockade in mice.
  • ||||||||||  Cdactin-O (CBM588) / Osel, Miyarisan
    Trial completion date, Trial primary completion date:  CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant (clinicaltrials.gov) -  Feb 22, 2024   
    P1,  N=36, Active, not recruiting, 
    Our results demonstrate that CBM588-centered intervention can adequately improve intestinal homeostasis and efficiently overcome resistance to PD-1 blockade in mice. Trial primary completion date: Dec 2023 --> Dec 2024 | Trial completion date: Dec 2023 --> Dec 2024
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cdactin-O (CBM588) / Osel, Miyarisan, Yervoy (ipilimumab) / Ono Pharma, BMS
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  P30CA033572: CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer (clinicaltrials.gov) -  Jan 2, 2024   
    P1,  N=30, Active, not recruiting, 
    CBM588-induced manipulation of the commensal microbiota holds the potential to enhance the efficacy of chemoimmunotherapy combinations, warranting further exploration of the synergy between CBM588 and immunotherapy. Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
    Combination nivolumab and ipilimumab with and without camu camu in first-line treatment of metastatic renal cell carcinoma (mRCC). (Level 1, West Hall; Poster Bd # M12) -  Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_688;    
    P1
    CheckMate214 demonstrated a survival advantage with ipi/nivo over sunitinib; unfortunately, 20% of cases developed primary progression to immunotherapy...Our group has previously proven that the addition of a live bacterial product (CBM588) enhances clinical responses in pts with mRCC treated with ICI, and the combination of ICI (Dizman et al., 2022) or with a tyrosine kinase inhibitor (Ebrahimi et al., 2023)...The study is currently open to enrollment. Clinical trial information: NCT06049576.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cdactin-O (CBM588) / Osel, Miyarisan, Yervoy (ipilimumab) / Ono Pharma, BMS
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  P30CA033572: CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer (clinicaltrials.gov) -  Sep 11, 2023   
    P1,  N=30, Active, not recruiting, 
    Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024 Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
  • ||||||||||  Cdactin-O (CBM-588) / Osel, Miyarisan
    Preclinical, Journal:  Clostridium butyricum MIYAIRI 588 alleviates periodontal bone loss in mice with diabetes mellitus. (Pubmed Central) -  Sep 2, 2023   
    The mechanism involves regulation of the gut microbiota and restoration of the integrity of the gut barrier to alleviate oxidative damage by elevating serum 4-HBA. This study suggests the possibility of CBM588 as a therapeutic adjuvant for periodontal treatment in diabetes patients.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Retrospective data, Journal:  Association of probiotic use with nivolumab effectiveness against various cancers: A multicenter retrospective cohort study. (Pubmed Central) -  Jul 8, 2023   
    In all cancers, no significant differences in treatment duration of nivolumab were observed between probiotic users and non-users (median 62.0 vs. 56.0, hazard ratio?=?1.02, p?=?0.825), whereas probiotic use, compared with non-use, in patients with gastric cancer was significantly associated with a longer duration of nivolumab treatment (55.0 vs. 31.0?days, hazard ratio?=?0.69, p?=?0.039). In conclusion, probiotics may improve the response to nivolumab and potentially prolong progression-free survival in patients with gastric cancer.
  • ||||||||||  Cdactin-O (CBM-588) / Osel, Miyarisan
    Clostridium butyricum alleviates DSS-induced colitis mice by inhibiting NLRP3 inflammasome activation () -  Jun 16, 2023 - Abstract #IDDF2023IDDF_183;    
    Methods Fourty-eight 6-8 week old C57BL/6 wild-type mice (WT) and matched NLRP3 knockout mice (KO) were randomly divided into six groups, and Clostridium butyricum MIYAIRI 588 was used to treat colitis mice...In the KO group, significant relief of symptoms in the DSS group, but no significant difference between the DSS group and CBM group. Conclusions CBM alleviates DSS-induced colitis by inhibiting NLRP3 inflammation activation, which may be another potential mechanism of action in the treatment of IBD.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cdactin-O (CBM588) / Osel, Miyarisan, Yervoy (ipilimumab) / Ono Pharma, BMS
    Enrollment closed, Combination therapy, Metastases:  P30CA033572: CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer (clinicaltrials.gov) -  Oct 14, 2022   
    P1,  N=30, Active, not recruiting, 
    Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023 Recruiting --> Active, not recruiting