Bruised and battered by its setback on pixantrone, Cell Therapeutics ($CTIC) is adding a new drug to its pipeline, paying $5 million upfront to license the North, Central and South American rights to Chroma's drug candidate tosedostat. Another $5 million is due on the launch of a Phase III trial, which the company says is scheduled to begin in the fourth quarter.
Cell Therapeutics CEO Jim Bianco was at Bio-Europe Spring in Milan on Tuesday, where he quickly launched into the company's plans to start a late-stage trial among acute myeloid leukemia patients in the fourth quarter of this year. Bianco, who suffered intense criticism from analysts and regulators after pixantrone's rejection, also used his presentation to highlight other aspects of CTIC's game plan for the rest of the year. He focused on a new late-stage trial for pixantrone, plans to appeal the FDA's rejection of its application, and the prospect of a possible fourth quarter approval for the drug in the EU. Finally, Bianco raised the prospect of the option Novartis had taken on pixantrone but never exercised.
Bianco's credibility has been under assault since the company lost a unanimous vote by an expert FDA panel a year ago. The FDA's Dick Pazdur told the experts that an agency analysis of pixantrone data had concluded that the drug group did not demonstrate a statistically significant improvement over the control arm. Pazdur added that only 140 of a planned 320 patients were recruited for the trial, with a mere eight U.S. patients in the study. And there is no indication that investors are willing to cut the company any slack at this point. CTIC's shares traded at 31 cents today.
- read the Cell release