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:6/23/2016)... Bracket , a leading clinical trial technology and specialty ... Bracket eCOA (SM) 6.0, at the 52 nd ... in Philadelphia , Pennsylvania.  A demonstration of ... its kind to fully integrate with RTSM, will be held ... a flexible platform for electronic clinical outcomes assessments that is ...
(Date:6/23/2016)... 23, 2016 Revolutionary technology includes ... Oticon , industry leaders in advanced audiology and hearing ... Oticon Opn ™, the world,s first internet connected hearing ... IoT devices.      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ... number of ,world firsts,: , TwinLink™ - ...
(Date:6/23/2016)... , June 23, 2016  Experian ... integrating and transforming the patient payment and ... several innovative new products and services that ... its revenue cycle offerings. These award-winning solutions ... efficient workflows, remain compliant in an ever-changing ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... ... Investment Group (TGIG), has initiated cultivation and processing operations at its production facility, ... Pahrump, Nevada. , Puradigm is the manufacturer of a complete system of proactive ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm Slone Partners is ... sequencing and genomics experience, as Vice President of North American Capital Sales at ... for leading the sales team in the commercialization of the HTG EdgeSeq system and ...
(Date:6/24/2016)... ... June 24, 2016 , ... Today, MTI-GlobalStem, a provider of ... other difficult to transfect cells, announces its launch of the PluriQ™ G9™ Gene ... System is a complete system for culturing and transfecting human pluripotent stem ...
(Date:6/24/2016)... City, FL (PRWEB) , ... June 24, 2016 , ... ... inflammation common after venous procedures, dermaka cream can be incorporated into the post-surgical treatment ... and minor surgical procedures. , dermaka cream is very effective for bruising and ...
(Date:6/24/2016)... Edwardsville, IL (PRWEB) , ... June 24, 2016 ... ... Darryll Beard, DDS, and Randall Markarian, DDS, are co-chairs for the Illinois State ... dental clinic Friday-Saturday, July 15-16 at the Gateway Convention Center in Collinsville. ...
Breaking Medicine News(10 mins):