Pluristem to file with FDA for bone marrow therapy
NEW YORK (AP) — Pluristem Therapeutics, which develops therapies that use placental cells, said it is preparing a Food and Drug Administration application for an experimental therapy to treat anemia caused by abnormal bone marrow.
The company's Vice President William Prather said Monday the company expects to file its application with the agency in the next 30 days.
The Israeli biotech company will ask the FDA to review its Placental Expanded cells for aplastic bone marrow as an orphan drug. Products reviewed under the orphan drug program can receive accelerated review, tax credits and seven years of competition-free marketing.
Healthy bone marrow produces various types of blood cells. People with aplastic bone marrow have a structural defect that causes them to produce fewer blood cells, resulting in anemia, fatigue and other symptoms. Without treatment the condition is almost always fatal.
Shares of Haifa, Israel-based Pluristem Therapeutics Inc. rose 28 cents, or 8.3 percent, to $3.66 in morning trading.