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:7/29/2014)... 2014 The prestigious "Discovery or Exploration ... recently awarded to Juliana Hillis and Kaylie O’Connell, students ... project, “From an Egg, Everything: America’s First IVF Baby". ... for the National History Day program during a week-long ... educators in Washington, D.C. , The growing popularity of ...
(Date:7/29/2014)... EXpressLO LLC, expert provider of focused ... solutions, has been granted patent number 8,789,826 by the ... incorporating a unique specimen carrier support grid design described ... company patent for EXpressLO LLC awarded to founder and ... complementary patents extend EXpressLO’s portfolio of intellectual property. The ...
(Date:7/28/2014)... DIEGO , July 28, 2014 ... cultivation technologies, today announced the appointment of biotechnology veteran ... of the board of directors. Levine replaces Cynthia ,CJ, ... immediately. She will remain chairman of the company,s board ... on Sapphire Energy,s mission to deliver commercial scale algae-based ...
(Date:7/28/2014)... According to a new market research ... (Bone and Joint) Market (By Technology - Stem ... - Bone Graft Substitutes, Osteoarticular Diseases, Allogeneic Products, ... Size, Share, Growth, Trends and Forecast, 2013 - ... market was valued at USD 2.6 billion in ...
Breaking Biology Technology:In Vitro Fertilization (IVF) was the Subject of This Year’s Winning Entry for the Prestigious Library of Congress “Discovery or Exploration in History Award” 2In Vitro Fertilization (IVF) was the Subject of This Year’s Winning Entry for the Prestigious Library of Congress “Discovery or Exploration in History Award” 3EXpressLO LLC Granted Second U.S. Patent for Innovative Specimen Preparation Methods 2Sapphire Energy Announces New CEO James Levine 2Sapphire Energy Announces New CEO James Levine 3Regenerative Medicine Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 2Regenerative Medicine Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 3Regenerative Medicine Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 4
... ... additional stability storage space, additional retain sample storage, and a controlled environment room. ... Wilson, NC (PRWEB) ... and short term storage of stability samples, sample management, and logistics for the Biotechnology, ...
... REGENSBURG, Germany, June 17 , ... the Field of Reproductive Medicine , - ... Exhibition in,Amsterdam (Stand 87/88) , The IT ... its new software for in vitro fertilisation, MedITEX IVF,at the 25th ...
... Advanced Cell Technology,s Chief Scientist, Robert Lanza yields answers to ... MSNBC.com featured today Dr. Robert Lanza,s book (co-authored with ... are the Keys to Understanding the True Nature of the ... The article by Science Editor Alan Boyle includes an ...
Cached Biology Technology:Precision Stability Storage Announces Upcoming Expansion 2Precision Stability Storage Announces Upcoming Expansion 3New IVF Software MedITEX to be Presented at the ESHRE Exhibition 2MSNBC Publishes Free Online Abridgment of 'Biocentrism' 2MSNBC Publishes Free Online Abridgment of 'Biocentrism' 3
(Date:7/29/2014)... territory of Ascension Island, one of the world,s largest ... , Writing in the journal Biodiversity and Conservation ... Island Government Conservation Department report that the number of ... has increased by more than 500 per cent since ... nests are now estimated to be laid on the ...
(Date:7/29/2014)... the University of Kent has shown for the first ... a breakthrough that could have a major impact on ... of Biosciences uncovered the mechanism whereby the physical properties ... actin filaments are ,fine-tuned, to undertake different functions. ... completely stable, providing a framework for the cell, others ...
(Date:7/29/2014)... 1 in 100,000 people characterized by a loss of ... unknown, a new study by a team of researchers at ... and other European institutions confirms for the first time that ... July in Nature Genetics , is an important step ... sphincter in the lower esophagus opens, allowing food to enter ...
Breaking Biology News(10 mins):Major turtle nesting beaches protected in 1 of the UK's far flung overseas territories 2Mysterious esophagus disease is autoimmune after all 2
... apparently had genomes no larger than that of a modern ... genome size among living species and then used that new ... extinct dinosaurs and birds, whose bone cells can be measured ... University and the University of Reading, were led by Chris ...
... mutations that give rise to a rare genetic disease, ... may have a broader role during human development, potentially ... An international team of researchers identified two genes that ... disease that affects an estimated one in 10,000 children. ...
... mutation in mice results in an enhanced long-term memory, ... the journal Cell, published by Cell Press. These findings ... a drug to treat memory loss, according to the ... increases levels of a natural memory-blocking protein. Animals that ...
Cached Biology News:Despite their heft, many dinosaurs had surprisingly tiny genomes 2Gene found for rare disorder may reveal new pathway in mental retardation 2Mutation improves memory, may lead to memory-enhancing pill 2Mutation improves memory, may lead to memory-enhancing pill 3
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Request Info...
Request Info...
Biology Products: