Pluristem obtains orphan drug status for aplastic anemia treatment

The disease is caused by the failure of hematopoietic stem cells in the bone marrow to produce red blood cells, white blood cells and platelets.

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has obtained orphan drug status for its PLacental eXpanded (PLX) cells for the treatment of aplastic anemia from the US Food and Drug Administration (FDA)

Aplastic anemia is a rare but serious disorder with a prevalence of less than 200,000 in the US. The disease is caused by the failure of hematopoietic stem cells in the bone marrow to produce red blood cells, white blood cells and platelets. The disease is considered an emergency and patients are supported with blood products in anticipation of a bone marrow transplant or drugs that suppress the immune system.

This is Pluristem's second orphan drug designation from the FDA, after the company obtained the status for PLX cells for the treatment of Buerger's disease in August 2011.

"Receiving orphan drug designation for aplastic anemia is an important event for Pluristem as it open pathways for using our PLX cells for additional indications in the field of hematology," said Pluristem chairman and CEO Zami Aberman.

Pluristem has established clinical advisory board of bone marrow transplantation experts from the US, Europe and Israel to advise the company on how to expand its treatments of bone marrow diseases and transplantations.

Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983, including seven years marketing exclusivity, a tax credit for certain clinical testing expenses, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants.

Published by Globes [online], Israel business news - www.globes-online.com - on February 21, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

5 Comments
View comments in rows
Update by email about comments talkback
POST
Comments
Your name
Please insert your name
Content
Hyperlink in a new window Hyperlink Right Left underline italic bold Bulleted List Ordered List Face1 Face2 Face3 Face4 Face5 Face6
Your comment

Thanks
You comment was recieved and soon will be published.
In posting comments, I agree to abide by the Terms of Use
Globes encourages lively and frank debate, but posts that the editors consider merely abusive or otherwise inappropriate will be removed. Report inappropriate content
Thank you for posting your comment, which will be reviewed for publication.
Loading Comments...load
Load more comments
MORE FROM GLOBES
Erez Vigodman Teva boosted by European drug recommendations

Teva's share jumped 4% in Tel Aviv, after climbing 4.9% on Wall Street.

Partner/Orange Partner launches smartphone medical services

The new services includes prescriptions, hospital referrals, and confirmation of illness.

Reuven Krupik Clal Biotech unit PolyHeal nears licensing deal

PolyHeal has signed an MOU with a European drug company for an exclusive global license.

Nasdaq Galmed jumps on FDA hepatitis drug approval

The FDA awarded Fast Track Designation to aramchol for the treatment of Non-Alcoholic Steato-Hepatitis.

artificial sweeteners Weizmann Inst: Sweeteners cause diabetes, obesity

A study found that artificial sweeteners adversely affect intestinal bacteria.

BioCancell share jumps on positive cancer trial results

The clinical trials demonstrated safety and effectiveness of the treatment on high-risk bladder cancer patients.

Trendlines Group set for Toronto IPO

The technological incubators company is raising C$9 at a company value of C$80 million, after money.

Reuven Krupik Clal Biotech sues Hyperion for $200m

Clal Biotechnology alleges Hyperion made "rash and ill-considered" decisions in the Andromeda affair.

pharmaceuticals Clal Biotech: No evidence of misconduct by us

Clal Biotech says documents it was shown by Hyperion do not indicate it committed any misconduct regarding Andromeda.

Soroka Hospital  picture: Eyal Yitzhar Visiting Israel’s wounded at Soroka

Soroka Medical Center in Beersheva, the Israeli hospital closest to Gaza, bears the medical brunt of Operation Protective Edge.

Twitter Facebook Linkedin RSS Newsletters גלובס