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

0

GOOD

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:5/24/2013)... Texas (PRWEB) May 24, 2013 ... benchmarking survey on kinase profiling carried out in ... details of the breakdown of the responses for ... the future (2015). It also highlights some interesting ... survey groupings. Two bottom-up models were developed to ...
(Date:5/24/2013)... Madison, WI (PRWEB) May 24, 2013 ... to the discovery and development of calcium-binding proteins ... publication of safety assessment study of apoaequorin ... an international journal published for the British Industrial ... the study was to investigate potential adverse effects, ...
(Date:5/23/2013)... N.Y. , May 23, 2013  BioScrip, Inc. ... Company will present at the Jefferies 2013 Global Healthcare ... Grand Hyatt New York. Richard ... Hai Tran , Chief Financial Officer, ... a.m. Eastern Daylight Time.   About BioScrip ...
(Date:5/23/2013)... May 23, 2013 PuraMed BioScience ® ... marketer of over-the-counter (OTC) medicinal and healthcare products, ... on the company based on low market capitalization ... Non-Prescription, All Natural Product to Treat Migraine Headaches ... #1 Prescription Competitor , Currently Available Nationwide ...
Breaking Biology Technology:Kinase Market Profiling - In House & Outsourced Trends 2015 Forecast in New Research Report at ReportsnReports.com 2Kinase Market Profiling - In House & Outsourced Trends 2015 Forecast in New Research Report at ReportsnReports.com 3Kinase Market Profiling - In House & Outsourced Trends 2015 Forecast in New Research Report at ReportsnReports.com 4Safety Assessment Study of Apoaequorin Published in Food and Chemical Toxicology 2PuraMed BioScience (PMBS) Issued Alert Based on Market Cap of $721,756 2PuraMed BioScience (PMBS) Issued Alert Based on Market Cap of $721,756 3
... - With the goal of capturing 10 percent of ... Tuesday signed an executive order directing the Department of Commerce ... to recruit new stem cell companies to Wisconsin. , ,Doyle ... Wisconsin, reaffirms the state's commitment to stem cell research. Proponents ...
... Iceland, The Netherlands, Japan or other developed nations, connecting to ... other impediments to doing business in those countries, e-commerce isnt ... you live or work in rural Wisconsin, where high-speed access ... Perhaps the passage of Senate Bill 483 this week by ...
... needed for AT&T to move forward on its deployment of ... this redeployment, AT&T should be setting its sights higher on ... is shortsighted. , ,The marketing strategy of Project Lightspeed should ... provide more services in a true broadband package. Instead, it ...
Cached Biology Technology:Doyle authorizes $5 million to woo stem cell companies 2Broadband bill will help develop rural Wisconsin 2Broadband bill will help develop rural Wisconsin 3AT&T should set sights higher than repackaging DSL with Project Lightspeed 2AT&T should set sights higher than repackaging DSL with Project Lightspeed 3AT&T should set sights higher than repackaging DSL with Project Lightspeed 4AT&T should set sights higher than repackaging DSL with Project Lightspeed 5AT&T should set sights higher than repackaging DSL with Project Lightspeed 6
(Date:5/22/2013)... a novel technique that can detect molecular variants in ... one of the most important, though time-consuming, processes in ... in Nature , post-doctoral researcher David Patterson, Professor ... the Center for Free-Electron Laser Science (CFEL) in Hamburg, ... fields to identify molecular variants apart, and to determine ...
(Date:5/22/2013)... 3 fatty acids in fish oil have long been ... the American Heart Association currently recommends eating at least ... rich in omega 3s. However, the mechanism behind this ... study, scientists led by Jason R. Carter of Michigan ... evidence that fish oil might specifically counteract the detrimental ...
(Date:5/22/2013)... and human health effects from disposal of millions ... scientists to recommend stronger government policies to encourage ... materials. That,s the conclusion of a new paper ... Technology . , Oladele A. Ogunseitan and colleagues ... for powering everything from smart phones to components ...
Breaking Biology News(10 mins):Detecting mirror molecules 2Detecting mirror molecules 3Fish oil may help the heart beat mental stress 2
... are investigating a radical new design for cargo ships ... enable non-native creatures to sneak into the Great Lakes ... have been identified in the Great Lakes, and ballast ... notorious zebra and quagga mussels and two species of ...
... 25 The U.S. Department of Homeland,Security ... collecting additional,fingerprints from international visitors arriving at ... The change is part of the department,s,upgrade ... security and,facilitate legitimate travel by more accurately ...
... two key proteins that guide one of the two ... shells -- their defense against the world. The ... antibiotics against gram-negative bacteria, like E. coli and salmonella, ... that produces their protective coating. "A long-term goal ...
Cached Biology News:U-M 'ballast-free ship' could cut costs while blocking aquatic invaders 2U-M 'ballast-free ship' could cut costs while blocking aquatic invaders 3DHS Begins Collecting 10 Fingerprints From International Visitors at New York's John F. Kennedy International Airport 2Ant guts could pave the way for better drugs 2
... from KUBTEC is a dual capability system with ... representation of the specimen under test. While the ... images, the micro focus source also allows the ... standard 2D images. The 50 mm x 50 ...
... BTX, the leader in electroporation products and ... innovative product line for experiment optimization and ... is a breakthrough in Molecular Delivery. The ... procedures that typically limited the number of ...
... (PR) Competitor Assay Kits are ideal ... receptor binding compounds using fluorescence polarization ... fusion of glutathione transferase to the ... receptor [PR-LBD(GST)] and a proprietary, fluorescently ...
... Eastman Kodak Companys Molecular Imaging Systems ... Image Station 4000 Digital Imaging Systems, ... technology for comprehensive fluorescence, luminescence, radiographic ... 4 million pixel CCD and 10x ...
Biology Products: