Navigation Links
European Medicines Agency (EMA) Waives Requirement to Test StemEx(R) in Paediatric Patients 17 Years of Age and Under
Date:1/18/2010

JERUSALEM, Israel, January 18 /PRNewswire/ --

- The International Study of StemEx, an Experimental Treatment for Leukemia, Lymphoma and MDS, is now Enrolling at Clinical Sites in Italy, Hungary, Spain, Israel and the U.S.

The Gamida Cell-Teva Joint Venture (JV) announced today that the Paediatric Committee (PDCO) of the EMA has granted product specific waivers for StemEx for all subsets of the paediatric population (birth to 17 years of age) in all conditions. The PDCO emphasized that the granting of the waivers should not prevent the JV from considering developing StemEx for children with conditions where there is a need. StemEx is being developed by a joint venture equally owned and operated by Gamida Cell and Teva Pharmaceuticals ( TEVA).

In order to register a new medicinal product in the European Union, a company generally needs to clinically prove efficacy and safety in paediatric patients in addition to adults. Moreover, a company has to submit to the PDCO a Paediatric Investigational Plan (PIP) for the four existing paediatric age subsets which cover from birth to 17 years of age. The JV submitted a PIP for the age group 12 -17 together with product specific waiver requests for the three age groups between birth to 11 years of age.

As the added value of StemEx lies primarily in the treatment of larger children and adult patients, the PDCO waiver is congruent with the JV's strategy to develop StemEx initially for adolescents and adults.

Ms. Michal Austin, director of regulatory affairs said, "It is well known that the limited number of stem cells in cord blood inhibits the therapeutic use of cord blood transplantation in adolescents and adults. Gamida Cell's technology takes this small population of cord blood stem cells and cultures it with limited differentiation, to a size that has the potential to offer a therapeutic treatment to larger children and adults. Thus, the goal of the JV is for StemEx to significantly widen the scope of a base treatment, already common practice in children. As such, we believe, and the Agency has agreed, that our first priority in developing StemEx will be to offer the treatment to those patients with the most unmet clinical need, meaning adolescents and adults. This means, we are still on track for a 2011 market launch."

Gamida Cell is currently enrolling for the study of StemEx as an investigational treatment for adolescents (larger children) and adults with leukemia at leading cord blood transplant clinical sites in Italy, Hungary, Spain, Israel and the U.S. For more information about the study: http://www.stemexstudy.com.

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 and bone marrow, 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 in an international pivotal trial at leading transplant centers in the U.S., Europe and Israel. StemEx has orphan drug designation in the U.S. and in Europe. 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.

    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. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
2. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
3. European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day
4. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
5. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
6. Threshold Pharmaceuticals Announces Two Presentations on Glufosfamide at the 2007 European Cancer Conference (ECCO)
7. Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress
8. Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System
9. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
10. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
11. Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 Roche ... received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) ... severe sepsis or septic shock. With this clearance, Roche ... provide a fully integrated solution for sepsis risk assessment ... associated with bacterial infection and PCT levels in blood ...
(Date:6/23/2016)... WAYNE, Pa. , June 23, 2016 ... provider, will launch its next generation clinical outcomes platform, Bracket ... DIA Meeting held on June 26 – 30, 2016 in ... 6.0, the first electronic Clinical Outcome Assessment product of its ... DIA Booth #715. Bracket eCOA 6.0 is a ...
(Date:6/23/2016)... Revolutionary technology includes multi-speaker listening ... industry leaders in advanced audiology and hearing aid technology, ... ™, the world,s first internet connected hearing aid that ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... ,world firsts,: , TwinLink™ - the first ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the ... to iHire in recognition of their exemplary accomplishments in worksite health promotion. , The ... Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort ... holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain ... Disease (SCD) is a disorder of the red blood cells, which can cause episodes ...
(Date:6/24/2016)... Francisco, CA (PRWEB) , ... June 24, 2016 ... ... CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive ... self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented ... in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor the ... Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With this award, ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm Slone Partners ... with extensive sequencing and genomics experience, as Vice President of North American Capital Sales ... be responsible for leading the sales team in the commercialization of the HTG EdgeSeq ...
Breaking Medicine News(10 mins):