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Working Group on New TB Drugs

PIPELINE > BIOLOGICS

Oral M. vaccae (V7)

Last Updated: 2-Apr-2012

Product Profile

Potential Will be inexpensive, scalable, available for production		Therapeutic Goal Clinical improvement/survival, shortening time to sputum clearance
Potential Biomarkers Reduction in IL4		Initial Target Population MDR +/-, HIV +/-

Concerns and Recommendations

Toxicity No known adverse effects of oral formulation. (Injection site toxicity previously reported for injectable formulation.)

Next Step Q2 2012

Additional Description New formulations need step by step validation. A phase IIb, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of orally formulated heat-killed Mycobacterium vaccae (V7) in combination with standard of care TB drugs among sputum smear positive subjects. The results will be compared to placebo control. The trial will consist of one stage with sputum evaluation at months 1 and 2. Cut-off timepoint for efficacy is one month. Study is designed to emulate real-world effectiveness by enrolling in addition to DST, patients with MDR-TB, TB/HIV and treatment failed cases. Location of R&D (Current & Planned): Canada, Ukraine, China

Administration and Handling

Dose	Route	Schedules	Cold Chain	Storage
	oral	daily dosing	No	Long shelf-life