RHEI Pharmaceuticals starts final trial of Tibozole in China
Scientists in Beijing say they have discovered a genetic cause for a certain type of premature baldness and they suggest their discovery offers hope in future that those who inherit this rare type of baldness will eventually be able to keep their hair. A team from Peking Union Medical College led by Xue Zhang
Full Post: Culprit found in rare type of baldness
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.
Up to 150,000 people suffering from severe asthma in the UK could benefit from taking antifungal medication already available from pharmacists, new research has found. University of Manchester scientists found that pills used to treat everyday fungal infections greatly improved symptoms of asthma in those patients that had an allergic reaction to one or more
Full Post: Antifungal medication could provide asthma relief for 150,000 UK sufferers
The effectiveness of voriconazole in combating fungal infections has been confirmed by a new study to be featured in the International Journal of Antimicrobial Agents, published by Elsevier. Fungal infections can kill people with weakened immune systems, which can be caused by AIDS, cancer treatment or organ replacement, and the research reinforces earlier findings
Full Post: Voriconazole effective in combating fungal infections
GeoVax Labs, Inc. has announced that the launch of its Phase 2a Human Vaccine Trials will take place in twelve sites across North and South America. These trials are conducted in collaboration with The National Institutes of Health (NIH), and the HIV Vaccine Trials Network (HVTN). “It is of significant importance to report this major
Full Post: GeoVax’s HIV/AIDS human vaccine trials to begin in North and South America
Phosphagenics Limited (”Phosphagenics”) announced today that it has initiated a phase 1 human clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a leading non steroidal anti-inflammatory drug (NSAID), diclofenac. The trial will compare the bioavailability and penetration of the topically applied Voltaren(R) gel (1% diclofenac), one of the leading
Full Post: Phosphagenics’ diclofenac enters trial phase in humans
Researchers have reported positive results from a safety and efficacy study pertaining to tribendimidine, a broad-based treatment for intestinal worm infections. The group’s results demonstrate the success of the new drug from China versus that of the standard albendazole for the treatment of hookworm, large roundworm, whipworm, and, for the first time, threadworm and
Full Post: Tribendimidine shows promise for intestinal worm infections