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:9/18/2014)... 18, 2014 Bipartisan passage this week ... designed to stimulate development and commercialization of new technologies ... by leaders of SPIE, the international society for ... Manufacturing and Innovation (RAMI) Act, now moves to the ... said they are optimistic that it will win passage ...
(Date:9/18/2014)... Mass. (PRWEB) September 18, 2014 A ... of an MRI scanner is currently being tested as ... and Women's Hospital in Boston with the aim of ... images, can make prostate cancer biopsies faster, more accurate, ... novel system also has the potential to deliver prostate ...
(Date:9/18/2014)... Washington, D.C. (PRWEB) September 18, 2014 ... Dick Durbin and Sen. Jim Risch for National Lab ... research projects from across the national laboratory system. Durbin ... Caucus, which aims to increase awareness of the reach ... breakthrough technologies and discoveries to address some of our ...
(Date:9/18/2014)... Research and Markets has announced ... Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & ... The global companion diagnostics market is expected ... to 2019. Factors such as rising need for personalized ... by the pharmaceutical industry, support from regulatory authorities, and ...
Breaking Biology Technology:House passage of high-tech manufacturing bill is move toward stronger economy, say SPIE leaders 2House passage of high-tech manufacturing bill is move toward stronger economy, say SPIE leaders 3Worcester Polytechnic Institute Participates in Clinical Trial for MRI-Compatible Robot Designed to Improve Accuracy of Prostate Cancer Biopsies 2Worcester Polytechnic Institute Participates in Clinical Trial for MRI-Compatible Robot Designed to Improve Accuracy of Prostate Cancer Biopsies 3Worcester Polytechnic Institute Participates in Clinical Trial for MRI-Compatible Robot Designed to Improve Accuracy of Prostate Cancer Biopsies 4Worcester Polytechnic Institute Participates in Clinical Trial for MRI-Compatible Robot Designed to Improve Accuracy of Prostate Cancer Biopsies 5Worcester Polytechnic Institute Participates in Clinical Trial for MRI-Compatible Robot Designed to Improve Accuracy of Prostate Cancer Biopsies 6Lab Day Highlight Labs' Contribution to U.S. Competitiveness and Innovation 2Lab Day Highlight Labs' Contribution to U.S. Competitiveness and Innovation 3Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & Forecasts to 2019 2Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & Forecasts to 2019 3
... Biotechnology companies are building on what they ... decade and are expected to drive this market ... Genetic Engineering and Biotechnology News ( GEN ... number of advantages, including reducing reagent consumption, increasing ...
... Mach One Corporation,(Pink Sheets: MNCN), a biological solutions company ... to the agricultural and consumer,market, announced today that it ... an Investor. , Mach One ... for,its first production facility in Wisconsin. The Original ...
... ABAX ), a medical products company manufacturing point-of-care ... its financial results for the third quarter of fiscal year ... 4:15 p.m. ET on Thursday, January 29, 2009.Participants can dial ... or can listen via a live Internet web cast, which ...
Cached Biology Technology:GEN Reports on Growing Reliance on Microfluidics Technology 2Mach One Completes Note Exchange 2Abaxis to Report Third Quarter Fiscal 2009 Financial Results Thursday, January 29, 2009 2
(Date:9/18/2014)... matter how many times it,s demonstrated, it,s still ... , But by using a signaling system ... their behavior to suit their population. In short, ... present, and act accordingly. , Once the population ... change from innocuous to pathogenic, or from unhelpful ...
(Date:9/18/2014)... information is stored in DNA, tiny strands of nucleic ... bodies. To express this genetic data, our DNA is ... into proteins that perform tasks in our cells. ... of RNA molecule. Unlike all other known RNAs, this ... circRNA molecules are abundant, little has been known about ...
(Date:9/18/2014)... 2014Many Americans across racial and ethnic groups describe ... on their day-to-day life, more so than other ... speech (57% of African-Americans, 49% of non-Hispanic whites, ... asked which disease or ailment is the worst ... among African-Americans followed by AIDS/HIV. Hispanics and ...
Breaking Biology News(10 mins):Researchers study vital 'on/off switches' that control when bacteria turn deadly 2Researchers study vital 'on/off switches' that control when bacteria turn deadly 3Scientists find how mysterious 'circular RNA' is formed, claim muscular dystrophy link 2Americans rate losing eyesight as having greatest impact on their lives 2Americans rate losing eyesight as having greatest impact on their lives 3
... heart-healthy, essential omega-3 fatty acid is about to improve ... advance will move biotechnology onto the average consumer,s daily ... deliver positive environmental impacts and increase production to feed ... on Horizon , Recently, the U.S. Food and Drug ...
... COLLEGE STATION "Four and 20 black birds baked in ... discovery, backed by DNA analysis, means scientists now know there is ... Africa than was previously thought. And if Dr. Gary Voelker has ... its susceptibility to the deforestation now occurring across its native habitat. ...
... two different protection programs to safeguard them from getting ... stopping and developing cancer. Until now, researchers assumed that ... Now for the first time, using an animal model ... (MDC) Berlin-Buch and the Charit University Hospital Berlin ...
Cached Biology News:New biotech advance to add heart healthy omega-3s to US diet 2African bird discovery proves there is something new under the sun 22 at 1 stroke -- how cells protect themselves from cancer 2
... This CLS number is a new ... Cornings product number. If showing no ... old Sigma-Aldrich number (R4276) or contact ... cap polystyrene (expanded surface, easy grip) ...
... EvoQuest Custom Peptide Services offer ... to meet your research needs. Services include: ... pure) Peptide synthesis, purified ... & modifications (acetylation, amidation, biotinylation, fluorescein, myristylation, ...
... ELISPOT (enzyme-lined immunospot) Kit analyzes interferon gamma ... A spot forms at the site where ... using a dissection microscope or automated ELISPOT ... of cells added to the microplate. This ...
... number is a new product ... Cornings product number. If showing ... under the old Sigma-Aldrich number ... for assistance. Material: cap ...
Biology Products: