Phase II trial of oral TB vaccine begins

Immune Network, Ltd., recently announced that its partner, Immunitor, has begun a Phase II clinical trial of a novel anti-tuberculosis immunotherapy consisting of Mycobacterium vaccae delivered orally.

Immunitor formulated the new tableted preparation according to clinically validated proprietary technology.

Studies over the last 30 years have shown that injectable versions of M. vaccae have been somewhat effective against drug-resistant TB and TB with HIV co-infection.

There have been encouraging results from Phase III clinical trials of an intradermal version sponsored by the U.S. National Institutes of Health. The invasive means of delivery, however, can lead to permanent scarring, which created a need to find a more manageable way to take the vaccine.

In response, Immunitor developed the oral formula of M. vaccae. Taken with standard TB drugs, it is expected to shorten treatment time to one month instead of the normal six to 24.

Phase I trials of the oral treatment were conducted last year in Argentina under the leadership of Professor John Stanford, a member of the Scientific Advisory Board of Immodulon Therapeutics based in London.

Products containing M. vaccae have been approved for sales in China and the European Union and the United States recognizes it as an orphan drug. M. Vaccae is expected to proceed to market quickly in those regions.

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