Shares of CTI tumble 25% |
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Shares of CTI tumble 25%
Cell Therapeutics Inc. lost more than 25 percent of it value this morning after the U.S. Food and Drug Administration questioned whether the Seattle biotech enrolled enough patients to test its experimental drug fro non-Hodgkin's lymphoma. The FDA report also questioned the toxicity of the drug, known as pixantrone. The stock was trading at 79 cents, down about 26 cents on the day. Shares fell to as low as 60 cents at one point this morning.
The FDA report said that CTI had planned to enroll 320 patients at 189 sites. But the company only attracted 140 patients at 66 sites for the study.
"The applicant stated that enrollment was hampered by investigator reluctance to enroll patients and that many investigators preferred to use either multi-agent chemotherapy or supportive care in this 3rd line population," the FDA report said.
The FDA is scheduled to meet on Wednesday to decide if the non-Hodgkin's lymphoma drug, pixantrone, should receive approval.
Xconomy has more details on the report, noting that the FDA still has questions about the quality of data in the study as well as the risk-reward qualities of the drug.
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