Navigation Links
RHEI Pharmaceuticals Announces the Initiation of the Final Clinical Study for Approval of Tibozole in China
Date:12/5/2008

New Product will Fill Void in the Local Treatment of Oral Candidiasis in Immunosuppressed Patients in China

PLAINSBORO, N.J., Dec. 5 /PRNewswire/ -- RHEI Pharmaceuticals, Inc. today 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.

About Tibozole

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.

About RHEI Pharmaceuticals

RHEI Pharmaceuticals is a venture backed specialty pharmaceutical company with operations in Belgium, the U.S. and in China that acquires, licenses, develops and commercializes in China proprietary drug therapies based upon the unmet needs of the emerging China pharmaceuticals market. The Company leverages its proprietary and extensive network of experienced clinical development and regulatory professionals in China to expedite approvals for pharmaceuticals new to the China market. RHEI's growing sales and marketing capabilities then provide broad patient access in China to these new and critically necessary therapeutics. RHEI applies its unique offering to branded pharmaceuticals, through its Ethical Division, and to consumer healthcare and OTC/natural supplement products through its Pharmacy Division. Additional information can be found at www.rheipharma.com.


'/>"/>
SOURCE RHEI Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. ISTA Pharmaceuticals Announces Phase III Results for Once-Daily Topical Xibrom(TM) 0.09%
2. VentiRx Pharmaceuticals Commences Phase I Clinical Trial of VTX-2337, a Novel TLR8 Agonist for the Treatment of Oncology
3. Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals Circadian Regulator Tasimelteon (VEC-162) Published in The Lancet
4. Poniard Pharmaceuticals Announces Management Changes and Focus on Development and Commercialization of Picoplatin
5. Jazz Pharmaceuticals and UCB Announce Positive Phase III Results for Sodium Oxybate (JZP-6) in Fibromyalgia
6. Memory Pharmaceuticals Achieves Enrollment Goal for Phase 2 Study of MEM 3454 in Cognitive Impairment Associated With Schizophrenia
7. Celator(R) Pharmaceuticals Announces Enrollment of First Patient in Phase 2 Study with CPX-351
8. Raptor Pharmaceuticals Corp. Announces Positive Phase IIa Clinical Study Results for Convivia(TM) Program
9. Raptor Pharmaceuticals to Collaborate with Centre Hospitalier Universitaire dAngers for Phase II Clinical Trial in Huntingtons Disease
10. VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease
11. Cadence Pharmaceuticals Reports Third Quarter 2008 Financial Results and Provides Clinical Development Programs Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2017)... A new Transparency Market Research report states ... at US$0.53 bn in 2013 and is predicted to touch US$2.38 ... 2014 and 2022. The title of the report is "Non-invasive Prenatal ... Trends and Forecast 2014 - 2022." ... Non-invasive prenatal testing (NIPT), also referred to as ...
(Date:1/23/2017)... Longer life expectancy and rising healthcare expenditure in ... medical device technologies. BCC Research reveals in its new report ... region, should see strong growth due to rising government healthcare spending, ... Continue Reading ... ...
(Date:1/23/2017)... January 23, 2017 The global  anxiety disorders and depression ... 2025. The rising incidence of depression worldwide is anticipated to drive the market ... in the declining demand for antidepressants in the recent years. ... ... View Research Logo ...
Breaking Medicine Technology:
(Date:1/23/2017)... ... January 23, 2017 , ... ... with the American Society of Anesthesiologists® (ASA®), the Foundation for Anesthesia Education ... of Orthopaedic Surgeons (AAOS) and the Cigna Foundation, encourages proposals supporting high ...
(Date:1/23/2017)... ... ... “The Inn at the Mill”: a story of love and redemption, hope and uncertainty ... and content. , “The Inn at the Mill” is the creation of published author, ... and is now living in Berks County on Crow Hill. The inn, the ...
(Date:1/23/2017)... VA (PRWEB) , ... January ... ... Nutrition Partnership (SNP) has launched online education programs and resources at seafoodnutrition.org/programs ... and nutritional benefits of a seafood-rich diet. These resources have been developed ...
(Date:1/23/2017)... ... January 23, 2017 , ... “Some Infallible Characteristics of Christ”: ... “Some Infallible Characteristics of Christ” is the creation of published author, Rev. Dr. Robert ... Church for thirteen years, a preacher for over nineteen, a pastor for over fifteen ...
(Date:1/22/2017)... ... January 22, 2017 , ... Phytocéane invites clients to take ... rest of the world with ZANZIBAR MILKY CREAM. Inspired by the beauty of Zanzibar, ... Virgin Coconut Oil and moisturizing vegetal coral to create this gentle, velvety body cream ...
Breaking Medicine News(10 mins):