The roller coaster known as Cell Therapeutics is back on the ascent today.
The Seattle-based biotech company (NASDAQ: [[ticker:CTIC]]) said its experimental lymphoma drug pixantrone (Pixuvri) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use. This is one of the key steps in the European regulatory process that usually leads to formal approval that would enable Cell Therapeutics to start selling the drug in the 27-member European Union. The company said it expects to get conditional regulatory approval “within the next few months.”
Shares of Cell Therapeutics shot up 25 percent, to $1.39, after the news crossed the wire this morning.
“We believe that Pixuvri will add an important treatment option for physicians and provide a meaningful impact on patients,” said Cell Therapeutics CEO James Bianco in a statement.
The European regulatory group recommended Pixuvri for conditional approval as a treatment on its own for adult patients with multiple relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. The drug is a member of the class of anthracyclines, which are chemotherapy agents. The Cell Therapeutics compound, originally acquired in 2003 from Italy-based Novuspharma, was modified in order to reduce the heart toxicity that sometimes limits the dosing and effectiveness of existing anthracyclines.
The EU recommendation comes just a couple of weeks after Cell Therapeutics stumbled with its pixantrone push in the U.S. The company withdrew its application for FDA approval after saying it wasn’t fully prepared for a public advisory committee meeting to review the drug on Feb. 9. The FDA turned down a previous pixantrone application, after the head of its cancer drug office complained it was based on a “single incomplete trial.” The company has said it plans to resubmit its application in the U.S. later in 2012.
