Corporate Banner
Satellite Banner
ADME Tox
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

BrainStorm Establishes Safety of Repeat Doses of NurOwn in Mice

Published: Friday, January 11, 2013
Last Updated: Friday, January 11, 2013
Bookmark and Share
Pre-clinical study conducted at GLP-compliant Harlan Laboratories.

BrainStorm Cell Therapeutics announced that it has successfully completed a 12-week repeat dose toxicity study with its NurOwn cells in mice. The company believes that the positive data from the study will support its efforts to obtain approval for a future repeat dose clinical study in ALS patients. The study was conducted at Harlan Israel’s laboratories, according to GLP (Good Laboratory Practice) standards of the FDA. The study protocol was approved by the Israeli Ministry of Health.

“We believe that repeat dosing is the key to the long-term clinical efficacy of NurOwn and we are anxious to begin testing in ALS patients. Our proprietary cryopreservation protocol will enable us to do so without having to perform repeat bone marrow aspirations for each dose,” commented Dr. Adrian Harel, BrainStorm’s CEO.

In the study, the animals received up to three intramuscular injections of NurOwn, produced from cryopreserved, or frozen, cells at concentrations 50–100 times the currently administered clinical trial dose. The treatment was well tolerated, and no adverse clinical effects were observed. Analyses included cytokine profile assays, clinical pathology, necropsy and macroscopic examination, as well as histopathological examinations.

BrainStorm is currently launching a Phase IIa combined treatment, dose-escalating trial of its NurOwn cell therapy candidate in ALS patients at the Hadassah Medical Center in Jerusalem. The company was recently fast-tracked by the Israeli Ministry of Health after reporting positive safety data for 12 patients in a Phase I/II trial.

BrainStorm is planning to expand its ALS clinical development to the United States in 2013, pending FDA approval. Towards that goal, the Company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS clinical trials at these institutions.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More than 4,600+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Rates of Nonmedical Prescription Opioid Use Disorder Double in 10 Years
Researchers at NIH have found that the nonmedical use of prescription opioids has more than doubled among adults in the United States from 2001-2002 to 2012-2013.
Self-Assembling Protein Shell for Drug Delivery
Made-to-order nano-cages open possibilities of shipping cargo into living cells or fashioning small chemical reactors.
Guided Chemotherapy Missiles
Latching chemotherapy drugs onto proteins that seek out tumors could provide a new way of treating tumors in the brain or with limited blood supply that are hard to reach with traditional chemotherapy.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
‘Human-on-a-Chip’ Could Replace Animal Testing
Researchers are developing a “human-on-a-chip,” a miniature external replication of the human body, integrating biology and engineering with a combination of microfluidics and multi-electrode arrays.
A New Approach to Chemical Synthesis
Communesins, originally found in fungus, could hold potential as cancer drugs.
‘Missing Tooth’ Hydrogels Handle Hard-to-Deliver Drugs
Rice University’s custom hydrogel traps water-avoiding molecules for slow delivery.
Copper is Key in Burning Fat
Berkeley Lab scientist says results could provide new target for obesity research.
Better Animal Model to Improve HIV Vaccine Development
Penn study identifies a new tool to produce better HIV vaccine designs.
Identifying Side-Effects At Early Stages Of Drug Development
An approach that could reduce the chances of drugs failing during the later stages of clinical trials has been demonstrated by a collaboration between the University of Cambridge and pharmaceutical company GlaxoSmithKline (GSK).
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!