Navigation Links
Kiadis Pharma Reports Successful End of Phase II Meeting With FDA for Reviroc
Date:12/19/2007

FDA Offers Special Protocol Assessment for Reviroc

AMSTERDAM, December 19 /PRNewswire/ -- Kiadis Pharma announced today that it has successfully completed an End of Phase II meeting for Reviroc with the U.S. Food and Drug Administration (FDA). Reviroc is under development for elimination of cancer cells from an autologous graft in bone marrow transplantations for end-stage blood cancer patients. The FDA agreed that the data from the completed phase II clinical Reviroc trial is sufficient to support the start of a phase III study. The FDA offered Kiadis Pharma its Special Protocol Assessment (SPA) procedure allowing Kiadis Pharma to work directly with the FDA to optimize the clinical design of the trial.

The FDA meeting followed the successful completion of a multi centre phase II study for Reviroc showing an improved overall survival after autologous bone marrow transplantation in Non-Hodgkin's lymphoma patients. The phase III clinical trial design for Reviroc will focus on patients with Large B cell lymphoma. Kiadis Pharma anticipates filing of the IND, SPA request and Orphan Drug Designation application with the FDA within the next few weeks.

"We are very pleased with the outcome of the End of Phase II meeting with the FDA and with the possibility to access the FDA's Special Protocol Assessment program. Together with the strong support by our principal investigators we are well prepared to design a clear path towards marketing authorization for Reviroc," said Manja Bouman, CEO Kiadis Pharma.

About Reviroc

Reviroc is being developed as a treatment that eliminates blood cancer cells from autologous transplants for patients with end stage blood cancer. An autologous transplant uses the patient's own bone marrow to serve as a graft. Bone-marrow transplants are broadly recognized as a treatment option for patients suffering from blood cancers, such as leukemia and lymphoma. One of the limitations of autologous bone mar
'/>"/>

SOURCE Kiadis Pharma
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Hearing Scheduled in the Delaware Court of Chancery for August 27, 2007 to Establish the Valid Approval and Consummation of the Merger Between PharmAthene, Inc. and Healthcare Acquisition Corp.
2. Pharmatek Adds Cytotoxic and High-Potent Drug Development Capabilities to San Diego Laboratory
3. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
4. Skystar Bio-Pharmaceutical Announces Second Quarter 2007 Results
5. Proceedings to Affirm Merger Between PharmAthene and Healthcare Acquisition Corp Initiated in Delaware Chancery Court
6. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
7. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
8. XTL Biopharmaceuticals Announces Financial Results for the Six Months Ended June 30, 2007
9. Dragon Pharmaceutical Reports Growth in Sales and Profits during Second Quarter of 2007
10. Cadence Pharmaceuticals Reports Second Quarter 2007 Financial Results
11. Baxa Announces 2008 Dates for STAR Center Professional Pharmacy and Cleanroom Training
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... (Q2 2015: +14% CER / 20% of sales) led the regional performance in ... , as well as solid contributions from Korea, India ... Middle East / Africa (Q2 2015: ... , Turkey and the United Kingdom ... excluding U.S. HPV sales, on demand across all customer classes. The top seven ...
(Date:7/29/2015)... ... July 29, 2015 , ... G-CON Manufacturing, Inc., ... of their 2nd generation cell therapy POD® design. The 2nd generation portfolio not ... represents a new POD® design. , “G-CON first offered our miniPOD CT ...
(Date:7/29/2015)... July 29, 2015  Therapath Neuropathology ( www.Therapath.com ... partnerships with VA and Military Medical centers both ... Density (ENFD) and Sweat Gland Nerve Fiber Density ... ( https://therapath.com/skin ). Demonstration of ... (ENFD) on punch skin biopsy is a highly ...
(Date:7/29/2015)... , July 29, 2015 /PRNewswire/ - RepliCel Life Sciences ... regenerative medicine company, is pleased to announce that the ... (RCI-02) have been locked.  Prototypes for industrial and ... for an application for CE mark clearance to ... in 2016. (Photo: http://photos.prnewswire.com/prnh/20150729/248373 ...
Breaking Biology Technology:QIAGEN Reports Results for Second Quarter and First Half of 2015 2QIAGEN Reports Results for Second Quarter and First Half of 2015 3QIAGEN Reports Results for Second Quarter and First Half of 2015 4QIAGEN Reports Results for Second Quarter and First Half of 2015 5QIAGEN Reports Results for Second Quarter and First Half of 2015 6QIAGEN Reports Results for Second Quarter and First Half of 2015 7QIAGEN Reports Results for Second Quarter and First Half of 2015 8QIAGEN Reports Results for Second Quarter and First Half of 2015 9QIAGEN Reports Results for Second Quarter and First Half of 2015 10G-CON Manufacturing Launches Their 2nd Generation Cell Therapy Cleanroom POD® 2G-CON Manufacturing Launches Their 2nd Generation Cell Therapy Cleanroom POD® 3Neuropathology services for VA and Military health systems 2RepliCel Life Sciences Unveils Innovative Dermal Injector Prototype 2RepliCel Life Sciences Unveils Innovative Dermal Injector Prototype 3RepliCel Life Sciences Unveils Innovative Dermal Injector Prototype 4RepliCel Life Sciences Unveils Innovative Dermal Injector Prototype 5
... Oct. 19 The US and European medical technology ... in 2009 but managed to improve overall net income ... financial discipline. While medtech has fared better than many ... put increasing strain on the industry,s long-standing business model. ...
... time scientists have been able to watch nanoparticles grow ... the foundation of nanotechnology and their performance depends on ... able to develop ways to control conditions under which ... range of applications including solar-cell technology and chemical and ...
... Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) announced ... financial results after the Nasdaq market closes on Thursday, October ... and webcast to discuss its financial results and provide a ... Eastern Time (5:30 a.m. Pacific Time). Participants can ...
Cached Biology Technology:Medtech Industry Successfully Weathering Challenges of Economic Downturn 2Medtech Industry Successfully Weathering Challenges of Economic Downturn 3Medtech Industry Successfully Weathering Challenges of Economic Downturn 4Medtech Industry Successfully Weathering Challenges of Economic Downturn 5Breakthrough in nanocrystals growth 2
(Date:7/2/2015)... DUBLIN , June 25, 2015 ... the addition of the "Next Generation Biometrics Market ... to 2020" report to their offering. ... $24.4 Billion by 2020, at a CAGR of 17.9% ... is the leading application for the market. Safran ...
(Date:6/26/2015)... 26, 2015 ATL Technology, LLC, a top provider ... in single use solutions, headquartered in Springville, Utah ... California corporation with locations in ... Jose, Costa Rica ). This acquisition will ... with ATL Technology,s existing facility in Costa ...
(Date:6/24/2015)... YORK , June 24, 2015 This ... market, over the next six years. It contains an ... the industry, along with their impact from the short, ... It also discusses the industry, market, and technology trends ... that the need of concerned authorities to efficiently manage ...
Breaking Biology News(10 mins):Next Generation Biometrics Market 2015 - Global Forecast to 2020 with Safran, NEC, 3M Cogent, Fujitsu & Suprema Dominating the $24 Billion Market 2Next Generation Biometrics Market 2015 - Global Forecast to 2020 with Safran, NEC, 3M Cogent, Fujitsu & Suprema Dominating the $24 Billion Market 3ATL Technology Announces Acquisition of MedConx, Inc. and Expanded Global Footprint 2Automatic Identification System Market by Class, by Platform, by Application and by Geography - Global Forecasts & Analysis to 2014 - 2020 2
... have an edge in keeping a healthier balance between the ... before reaching menopause. Premenopausal women are known to have ... afterward their risks are essentially the same as men, says ... at the Medical College of Georgia. The reason appears ...
... populations of Canada,s southern Rockies are a more distinct ... study by University of Calgary researchers that is shedding ... In a study published in the current issue ... Environmental Design PhD candidate Byron Weckworth and his research ...
... (Jan. 28, 2009) Virginia Commonwealth University researchers have ... in regulating mitochondria, the energy-producing machines of cells. This ... new treatments for heart disease to boost energy in ... of cancer. In the study, published online Jan. ...
Cached Biology News:Researchers may have found why women have an edge on salt-sensitive hypertension 2Mountain caribou's ancient ancestry revealed 2
BD BioCoat BD MatrigelTM Matrix 100 mm Culture Dishes for hepatocytes, tissue-culture treated polystyrene with a uniform application of MATRIGEL Matrix....
...
... internal standard for the quantification of 5-OxoETE ... is a polyunsaturated keto acid formed by ... It stimulates cytosolic calcium levels in neutrophils ... selectively stimulates the migration and degranulation of ...
... a 10.0 kb Autographa californica (AcNPV) polyhedrin ... AcNPV polyhedrin promoter and two AcNPV p10 ... a Sma I cloning site, followed by ... inverted polyhedrin promoter has been inserted containing ...
Biology Products: