Drugs / CBM588
CBM588
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 missed | ||||||
| Phase 1 | NCT06399419 | Jun 2024 → Oct 2026 expected | clear cell renal carcinoma, sarcomatoid renal cell carcinoma | Osel, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05122546 | Nov 2021 → Jan 2027 expected | clear cell renal carcinoma, papillary renal cell carcinoma, sarcomatoid renal cell carcinoma | City of Hope Medical Center | Active not recruiting | Missed primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT01077245 | Feb 2010 → Nov 2013 | Clostridium difficile colitis | Osel, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-06-28 | Osel, Inc. | Results City of Hope Study Suggests Changing the Gut Microbiome Improves Health Outcomes for People Newly Diagnosed With Metastatic Kidney Cancer oselinc.com ↗
City of Hope Study Suggests Changing the Gut Microbiome Improves Health Outcomes for People Newly Diagnosed With Metastatic Kidney Cancer |
| 2022-02-28 | Osel, Inc. | Results City of Hope and Osel Announce Live Biotherapeutic Product CBM588 May
Enhance Efficacy of Immunotherapy for Patients With Metastatic Kidney Cancer oselinc.com ↗
To our knowledge, this is the first randomized clinical trial to demonstrate that a live bacterial product can modulate the gastrointestinal microbiome and enhance immunotherapy response in cancer patients. |
| 2021-06-07 | Osel, Inc. | Results Osel Announces Positive Results from Phase 1b Trial of Live Biotherapeutic Product CBM588 in Combination with Checkpoint Inhibitor (CPI) Therapy in Metastatic Renal Cell Carcinoma oselinc.com ↗
Osel Announces Positive Results from Phase 1b Trial of Live Biotherapeutic Product CBM588 in Combination with Checkpoint Inhibitor (CPI) Therapy in Metastatic Renal Cell Carcinoma |
All press releases naming this drug 4 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CBM588 | “This study is a Phase 2 blinded, placebo-controlled, randomized clinical trial of an oral probiotic product, MIYA-BM Fine Granules \[Clostridium butyricum MIYAIRI 588 Strain...” NCT01077245 ↗2“CBM588 is a strain of bacteria that can restore species of Bifidobacterium to the microbiome.” NCT05122546 ↗ |
| Known as | Clostridium butyricum MIYAIRI 588 Strain | “This study is a Phase 2 blinded, placebo-controlled, randomized clinical trial of an oral probiotic product, MIYA-BM Fine Granules \[Clostridium butyricum MIYAIRI 588 Strain...” NCT01077245 ↗ |
| Known as | MIYA-BM | “This study is a Phase 2 blinded, placebo-controlled, randomized clinical trial of an oral probiotic product, MIYA-BM Fine Granules \[Clostridium butyricum MIYAIRI 588 Strain...” NCT01077245 ↗ |
| Modality | Other / unclassified | “This study is a Phase 2 blinded, placebo-controlled, randomized clinical trial of an oral probiotic product, MIYA-BM Fine Granules \[Clostridium butyricum MIYAIRI 588 Strain...” NCT01077245 ↗ |
| Route | Oral | “Two hundred patients who meet all eligibility criteria will be randomized in a 1:1 fashion to receive either MIYA-BM (2g/dose) or placebo orally twice daily for 42 days.” NCT01077245 ↗ |