Navigation Links
Kiadis Pharma Reports Successful End of Phase II Meeting With FDA for Reviroc

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 marrow transplantations is the high relapse rate associated with this treatment. This is often caused by the presence of cancer cells in the transplant and the fact that the patients' own white blood cells does not fight the cancer. Reviroc has been developed to remove residual tumor cells from the graft.

English release is provided by Kiadis Pharma. Equivalent translations are from a third party.

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

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:
(Date:11/26/2015)... , November 26, 2015 ... --> Accutest Research Laboratories, a ... Research Organization (CRO), has formed a ... Center - Temple Health for joint ... ,     (Photo: ) , ...
(Date:11/25/2015)... , November 26, 2015 ... Biobanking Market 2016 - 2020 report analyzes that ... integrity and quality in long-term samples, minimizing manual ... cost-effectiveness. Automation minimizes manual errors such as mislabeling ... efficiency. Further, it plays a vital role in ...
(Date:11/25/2015)... 2 nouvelles études permettent d ... différences entre les souches bactériennes retrouvées dans la plaque ... humains . Ces recherches  ouvrent une nouvelle ... charge efficace de l,un des problèmes de santé ... .    --> 2 nouvelles études permettent d ...
(Date:11/25/2015)... HOLLISTON, Mass. , Nov. 25, 2015 ... HART ), a biotechnology company developing bioengineered organ implants ... McGorry will present at the LD Micro "Main ... 2:30 p.m. PT. The presentation will be webcast live ... Management will also be available at the conference for ...
Breaking Biology Technology:
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 Research ... of the "Capacitive Fingerprint Sensors - Technology and ... --> --> ... market, especially in smartphones. The fingerprint sensor vendor Idex ... fingerprint sensor units in mobile devices and of the ...
(Date:11/19/2015)... 19, 2015  Although some 350 companies are actively ... a few companies, according to Kalorama Information. These include Roche ... the market share of the 6.1 billion-dollar molecular testing ... Market for Molecular Diagnostic s .    ... still controlled by one company and only a handful ...
(Date:11/17/2015)... , November 17, 2015 Paris ...   --> Paris from 17 th ... DERMALOG, the biometrics innovation leader, has invented the first combined ... on the same scanning surface. Until now two different scanners ... one scanner can capture both on the same surface. ...
Breaking Biology News(10 mins):