EXTON, Pa., Aug. 6 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.
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"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."
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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," stated Dale N. Gerding, MD, Associate Chief of Staff for Research at the Hines VA Hospital. "Despite the effectiveness of current acute treatment options, CDI recurrence remains a significant unmet medical need and NTCD presents a unique opportunity to not only reduce CDI recurrent disease but to also potentially prevent primary CDI in high-risk patients taking antibiotics."
About Clostridium difficile
One of the most serious problems facing the U.S. healthcare system today is hospital-acquired infections (HAIs) and Clostridium difficile infection is one of the most common and devastating HAIs. The incidence of Clostridium difficile observed in U.S. healthcare facilities more than doubled approximately every five years since 1999 and the reported mortality rates from Clostridium difficile in the U.S. have more than quadrupled in the last decade to 23.7 per million. Elderly patients exposed to antibiotics, long-term care patients, or those who have a serious underlying illness are at greatest risk to contract the disease. Patients with this disease have GI tract conditions that are significantly different from those of a healthy individual due to infection. Typical symptoms include diarrhea (which can be severe), fever, nausea, abdominal pain, and dehydration, though cases can lead to life-threatening complications such as megacolon, peritonitis and perforation of the colon.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. ViroPharma commercializes Cinryze(TM) (C1 esterase inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency (for prescribing information on ViroPharma's commercial products, please download the package inserts at http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including cytomegalovirus (CMV), HAE, and C. difficile.
ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide the Company's current expectations or forecasts of future events. Forward-looking statements in this press release include statements regarding ViroPharma's clinical development programs, including statements that NTCD may significantly reduce the incidence of recurrent disease for patients with CDI. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. The studies described in this press release represent the initial human studies with NTCD and the results of these studies may not support any or all of the statements in this press release. There can be no assurance that our Phase 1 programs will yield positive results or that we will conduct additional studies with NTCD. These factors, and other factors, including, but not limited to those described in ViroPharma's annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission during 2009, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
SOURCE ViroPharma Incorporated
