Corporate Banner
Satellite Banner
Pharma Outsourcing
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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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.

Related Content

First Patient Enrolled in BrainStorm's Phase II ALS Trial
Patient enrollment in Phase II trial at Massachusetts General Hospital in Boston.
Tuesday, June 10, 2014
BrainStorm Announces Clinical Data for Safety and Supporting Efficacy of NurOwn™ Based on Initial Phase I/II Results
Data from patients in ALS Phase I/II human clinical trial treated with NurOwn™ technology do not show any side effects.
Wednesday, January 18, 2012
BrainStorm Cell Therapeutics Secures Funding to Reach Clinical Trials for ALS
New funding includes a grant from the Israeli government’s Office of the Chief Scientist and private investment.
Monday, September 07, 2009
Scientific News
Therapy Halts Progression of Lou Gehrig’s Disease
Researchers at Oregon State University announced today that they have essentially stopped the progression of amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, for nearly two years in one type of mouse model used to study the disease – allowing the mice to approach their normal lifespan.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
UTSW Researchers Identifies How Drugs Alter Pancreatic Cancer Cells
The findings were published in Cell Reports.
Researchers Identify Process that Causes Chronic Neonatal Lung Disease
Study determines how the NLRP3 inflammasome activates the protein Interleukin 1 beta.
Dengue Vaccine Enters Phase 3 Trial
Investigational vaccine to prevent ‘breakbone fever’ developed at NIH.
Trying to Conceive Soon After a Pregnancy Loss May Increase Chances of Live Birth
NIH study finds no reason for delaying pregnancy attempts after a loss without complications.
BRCA1 Deficiency Increases the Sensitivity of Ovarian Cancer Cells to Auranofin
An anti-rheumatic drug could improve the prognosis for ovarian cancer patients exhibiting a deficiency of the DNA repair protein BRCA1, a study suggests.
Shingles Vaccine Helps Protect Older Patients with End-stage Renal Disease
Kaiser Permanente study advances knowledge about safety and effectiveness of vaccine commonly given to older adults.
AMRI Acquires Whitehouse Laboratories
Strategically extends AMRI's analytical offerings in rapidly expanding area of outsourcing services.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!