Navigation Links
Data Monitoring Committee Recommends Continuation of Phase III Study of StemEx(R), a Cord Blood Stem Cell Product, for Leukemia and Lymphoma
Date:2/10/2010

JERUSALEM, February 10 /PRNewswire/ -- The Gamida Cell-Teva Joint Venture (JV) announced today that the Data Monitoring Committee (DMC) has independently reviewed preliminary data from the pivotal registration, Phase III clinical trial of StemEx (called ExCell) and has recommended that the JV continue to enroll patients in this study. The next data analysis is anticipated to take place during Q2 2010. StemEx is being evaluated as a therapeutic treatment for adolescents and adults with blood cancers such as leukemia and lymphoma, who cannot find a family related matched bone marrow donor.

The DMC's primary charge is to ensure that the study is conducted in an ethical manner that does not expose participants to undue risk. In addition, the Committee monitors the quality and overall conduct of the study and assesses whether to recommend that the sponsor modify or terminate an ongoing study, or whether to request further information for review. The DMC for the Phase III StemEx study, comprised of an independent group of medical and scientific experts, reviewed safety and efficacy data from participating sites to assess treatment benefit (or harm) to study participants. The DMC had no safety concerns and recommended that accrual on the study continue.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell said, "This is another important milestone, that the DMC has reviewed the data and recommended continuing the phase III study of StemEx. With this green light, we shall continue enrolling patients in the trial with plans to bring StemEx to the market in 2011. We also hope that today's news will help to increase awareness of StemEx as an investigational treatment amongst patients with leukemia and lymphoma to consider in consultation with their physician."

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining unit of non-manipulated cells. The ExCell study is currently enrolling adolescents and adults with high-risk hematologic malignancies, at clinical sites in the U.S., Italy, Spain, Hungary and Israel. (http://www.stemexstudy.com and http://www.clinicaltrials.gov )

About Gamida Cell

Gamida Cell Ltd. is a world leader in stem cell expansion technologies and therapeutic products. The company is developing a pipeline of products in stem cell transplantation and in tissue regeneration to effectively treat debilitating and often fatal illnesses such as cancer, hematological, autoimmune and ischemic diseases. Gamida Cell's therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell's flagship product, StemEx, is now being studied as a therapy, for patients with blood cancers who cannot find a family related matched bone marrow donor, in an international phase III trial at leading transplant centers in the U.S., Europe and Israel. StemEx has orphan drug designation in the U.S. and in Europe with 7-10 years market exclusivity, in addition to long term patent protection. It is also expected to be among the first allogeneic cell products to reach the market in 2011. Gamida Cell's current shareholders include: Elbit Imaging, Biomedical Investment, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com. For information regarding the ExCell study: http://www.stemexstudy.com.

    Press contact:
    Marjie Hadad
    Media Liaison/IR
    Gamida Cell
    marjie@gamida-cell.com
    +972-54-536-5220


SOURCE Gamida Cell Ltd.


'/>"/>
SOURCE Gamida Cell Ltd.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Elbit Imaging Announces Data Monitoring Committee Recommends Continuation of Phase III Study of StemEx(R), a Cord Blood Stem Cell Product, for Leukemia and Lymphoma
2. New Research Gives Insight to the Frequency of Doctor Shopping Occurring Within Prescription Monitoring Programs
3. FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System
4. Revolutionary Radiation Monitoring Device for CT Scans
5. Statement From the Consumer Healthcare Products Association(CHPA) on Annual Monitoring the Future Survey on Drug Abuse
6. ARKRAY, Inc. Receives FDA 510k Clearance on the Assure(R) Platinum Auto-Code Blood Glucose Monitoring System
7. Reportlinker Adds EEG/EMG/Brain Function Monitoring - Global Market Trends
8. Reportlinker Adds Hemoglobin A1c Monitoring - Global Market Trends
9. Nonin Medical is Recognized by Frost & Sullivan for Remote Patient Monitoring Leadership
10. Reportlinker Adds Holter Monitoring Systems - A Global Market Review
11. Reportlinker Adds Blood Pressure Monitoring & Measurement Instruments - A World Market Analysis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... , Sept. 22, 2017  As the latest ... Senators Bill Cassidy (R-LA) and Lindsey ... notes that the medical device industry is in an ... device tax, the 2.3% excise tax on medical device ... they also want covered patients, increased visits and hospital ...
(Date:9/18/2017)... Pa. and KALAMAZOO, Mich. , Sept. 18, ... , and OptiMed Specialty Pharmacy of ... to offer a strategic hub service that expedites and ... sought-after personal spirometer, Spiro PD 2.0, and wellness management ... spirometer is a medical device used to measure lung ...
(Date:9/12/2017)... 12, 2017  Consumer reviews on the independent review site ... number one company for hearing aids, ranking it higher than ... ... by Consumers For Hearing Aids ... is an online store that provides high performance, state-of-the-art, German-engineered hearing ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... As health professionals work to improve their approach to healthcare, there is a ... filling out a survey; in many cases health professionals and patients are working together ... research on the importance of active engagement with patients and members of the public ...
(Date:10/13/2017)... Ky. (PRWEB) , ... October 13, 2017 , ... The ... MPH to become its next President and Chief Executive Officer, succeeding Dr. James C. ... CEO Elect beginning July 1, 2018 until Dr. Puffer’s retirement at the end of ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a ... utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the ... a CBD form that can be easily incorporated into liquid products, while reducing costs ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Lori R. Somekh, ... member of ElderCounsel, a national organization of elder law and special needs planning attorneys. ... and rules. It also provides a forum to network with elder law attorneys nationwide,” ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
Breaking Medicine News(10 mins):