RHEI Pharmaceuticals has begun the final China clinical trial for Tibozole, a
locally active antifungal with low dose miconazole in a patented mucoadhesive
system. Tibozole will attempt to approve its efficacy as a treatment for oral
candidiasis, a condition that affects immuno-compromised patients with HIV/AIDS
and cancer patients undergoing chemotherapy.
RHEI Pharma, a venture-backed
company, has offices in the US and Belgium, but its operations are in China. The
company seeks to license the China rights to drugs, which it then brings through
the SFDA approval process and markets in China. It has a sales force numbering
110 employees that market directly to China hospitals.
Oral candidiasis,
often known as thrush, is a fungal infection of the mouth and/or throat usually
caused by Candida albicans. It appears as thick white or cream-colored deposits
on mucosal membranes. The infected mucosa of the mouth may appear inflamed.
A tablet, Tibozole is placed on the gums and remains there for up to 12
hours, slowly releasing its ingredients. RHEI says the drug is a viable
alternative to systemic drugs, if patients are not able to tolerate a systemic
drug, or in cases where drug interactions are feared.
In the 350 patient
clinical trial, Tibozole will be compared to Sporanox (itraconazole) in patients
with 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. RHEI expects to complete its NDA filing with the
SFDA late in 2009.
RHEI licensed Tibozole from Tibotec, a subsidiary of
Johnson & Johnson (NYSE:
JNJ).
Tibozole is approved for use in a number of European and African countries, but
not in the US.
In addition to the oral candidiasis product, RHEI owns
the China rights to:
• APF530, an anti-nausea and vomiting drug from
A.P. Pharma (NSDQ:
APPA)
currently in Phase III trials; and
• Asacard, a controlled-release form of
aspirin from Flamel Technologies SA
