Osel Inc | Harnessing the microbiome improving health Osel filed a new IND for CBM588 oncology indications in early 2024 and has begun a Phase 1 dose escalation trial in advanced kidney cancer with a new capsule formulation of CBM588 at the City of Hope Comprehensive Cancer Center The study is now enrolling patients See clinicaltrials gov NCT06399419 for contact information
About Osel About Osel Osel’s mission is to develop and commercialize a broad portfolio of Live Biotherapeutic Products (LBPs) that prevent or treat conditions resulting from disruptions of the human microbiome
Clinical Pipeline | Osel Inc Osel’s LACTIN-V is a live biotherapeutic product addressing women’s health disorders LACTIN-V is under development for preventing recurrent BV and preterm birth It contains Lactobacillus crispatus CTV-05, a single strain of hydrogen peroxide-producing vaginal Lactobacillus that is part of the natural vaginal microbiome of many healthy women
Osel News | Osel Inc Osel holds the exclusive worldwide intellectual property rights for the use of Clostridium butyricum in oncology in combination with immune checkpoint inhibitors (ICIs) including the PD-1, PD-L1 and CTLA-4 inhibitors nivolumab, ipilimumab, pembrolizumab, cemiplimab, durvalumab, daclizumab, avelumab, or atezolizumab
LACTIN-V - Osel Inc Osel’s LACTIN-V is a live biotherapeutic product addressing women’s health disorders It incorporates a single species and strain of Lactobacillus that is part of the natural microbiome of healthy women and that has been selected for features that restore health and prevent recurrence of infection
Our Science | Osel Inc Our Science Osel is a pioneer in the development of Live Biotherapeutic Products to modulate the microbiome The microbial communities that inhabit different parts of the body are collectively called the Human Microbiome Recent scientific discoveries have demonstrated that the microbiome plays an important role in the maintenance of health
Women’s Health - Osel Inc The vaginal microbiome of most women is dominated by specific Lactobacillus species that play an important role in reproductive health by reducing the risk of urogenital infections and obstetric complications, and Lactobacillus crispatus is the most protective vaginal species Dysbiosis is a disruption of vaginal microbial ecosystem with a loss of protective hydrogen peroxide-producing
Osel Publications | Osel Inc Vaginal Lactobacillus crispatus persistence following application of a live biotherapeutic product: colonization phenotypes and genital immune impact June 21, 2024 A nested sub-study in 32 participants receiving LACTIN-V in the Phase 2b BV trial found that 72% demonstrated clinically relevant colonization (CTV-05 absolute abundance >106 CFU mL) while 28% of women demonstrated colonization
MIYA-BM - Osel Inc Osel plans to conduct Phase 2 and Phase 3 trials and file a Biologic License Application (BLA) with FDA Osel is also intends to evaluate the therapeutic potential of MIYA-BM for the treatment of IBS and for inflammatory bowel disease, such as Ulcerative Colitis (UC) Several clinical trials with LACTIN-V have already been completed
Frequently Asked Questions | Osel Inc LACTIN-V is a live biotherapeutic product (LBP) containing the live bacterium Lactobacillus crispatus CTV-05, a naturally occurring member of the human vaginal microbiome LBP is defined by the FDA as a biologic drug that contains live microorganisms for the prevention, treatment, or cure of a disease or condition of human beings, and not a vaccine