RHEI Pharmaceuticals, Inc. has announced that the final clinical trial for Tibozole, a locally active antifungal with low dose miconazole in a patented mucoadhesive system, has been initiated in China.
This will be the last clinical trial conducted for submission of the New Drug Application (NDA) to the State Food and Drug Administration (SFDA) in China. RHEI licensed Tibozole from Tibotec, a Johnson and Johnson company.
This study will compare Tibozole to Sporanox (itraconazole) and include approximately 350 patients who have oral candidiasis. Patients will be treated once daily for a maximum of 14 days. The endpoint is clinical and mycological cure. The study is expected to continue through most of 2009, with an expected NDA filing in China toward the end of next year.
"If and when approved, Tibozole will be the first local azole treatment in the Chinese market for oral candidiasis," said Dr. Geert Cauwenbergh, Chief Executive Officer and Chairman of RHEI Pharmaceuticals. "Although very effective, systemic drugs can have systemic side effects and drug interactions in certain patients, like those with cancer or AIDS, who are often on multiple other therapies. Tibozole, a locally active azole derivative in a patented slow release mucoadhesive system, will be a welcome alternative when systemic absorption could create issues in patients."
About Oral Candidiasis
Oral candidiasis, which is sometimes called thrush, is a fungal infection of the mouth and/or throat caused by Candida albicans, although other related Candida may be involved. It appears as thick white or cream-colored deposits on mucosal membranes. The infected mucosa of the mouth may appear inflamed. Oral candidiasis often occurs in immunocompromised people such as those with cancer or AIDS/HIV.
Tibozole(TM) is used for the treatment of oro-pharyngeal candidiasis (OPC), a common opportunistic infection in people with HIV/AIDS. Tibozole combines the antifungal drug miconazole nitrate with an innovative drug delivery system in the form of a tablet, which sticks to the gums above the eyetooth for up to 12 hours. The unique MAT technology enables the once daily administration of a topical antifungal for OPC for the first time. Tibozole is currently approved for marketing in a number of European and African countries.