ViroPharma Announces Initiation Of Non-Toxigenic Clostridium Difficile Phase...( EXTON Pa. Aug. 6 /- ViroPharma ...),Health

EXTON, Pa., Aug. 6 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that dosing has begun in the Phase 1 clinical trial for NTCD (non-toxigenic Clostridium difficile), a novel treatment approach for preventing recurrent Clostridium difficile infections (CDI). NTCD contains the spores of a non-toxin producing strain of C. difficile.

"Colonization of the large bowel with non-toxin producing strains of C. difficile is known to prevent the development of symptomatic CDI," commented Dr. Colin Broom, ViroPharma's chief scientific officer. "We have the opportunity with NTCD to develop this preventative therapy to significantly reduce the incidence of recurrent disease for patients with CDI. The ultimate goal is to colonize patients with this particular strain of non-toxin producing C. difficile thereby protecting patients until normal GI flora returns."

The Phase 1 study will determine the safety and tolerability of NTCD dosed orally as single and repeat escalating doses in healthy young (18-45 years of age) and older (60 years of age and older) adults. The study is being conducted in Switzerland. Should the therapy be well tolerated, the company plans to initiate NTCD repeat dosing in older adults following exposure to oral antibiotics. Antibiotic use is associated with disruption of gastrointestinal flora which renders individuals susceptible to C. difficile colonization. The goal of NTCD dosing following antibiotic exposure is to colonize with this non-toxigenic strain of C. difficile and to prevent colonization by toxigenic strains, thereby preventing disease.

"NTCD is a novel live-organism biotherapeutic approach to restoring bacterial production against CDI that has been disrupted by antibiotic treatment," state
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