Cell Therapeutics gets widely anticipated FDA rejection

The FDA has rejected Cell Therapeutics' application for Pixuvri (pixantrone) for relapsed or refractory aggressive non-Hodgkin's lymphoma--a decision that was widely expected after an expert panel voted unanimously against the drug's approval. And the FDA certainly wasn't dragging its feet on this decision: The agency delivered the news well ahead of the April 23 deadline.

The FDA rejection was based primarily on the issues raised by the ODAC committee last month, including questions about whether the drug was effective and concerns that Cell Therapeutics managed to enroll only 140 of a planned 320 patients in the trial. The company says in a statement that it plans to undertake a new trial for the drug. Meanwhile, it will make pixantrone available to lymphoma patients as part of the FDA's compassionate use program.

But TheStreet's Adam Feuerstein points out that without raising more money, Cell Therapeutics will find it almost impossible to fund another late-stage trial of the drug, which would take years to conduct and may or may not result in data worth submitting to the FDA. The developer, he points out, doesn't have enough cash to make it through 2010, and is facing $40 million in debt that will come due in June. "CEO Jim Bianco is a biotech magician when it comes to raising money...so perhaps he can keep the enterprise afloat somehow. Yet even if the company manages to pare its expenses, raise money to stay in business and find the funds to run a new pixantrone clinical trial, the company's future remains very much in doubt," notes Feuerstein.

- here's Cell Therapeutics' release
- read TheStreet article