[Updated with share price, 4:30 pm ET]
Cell Therapeutics is betting the farm on an experimental drug for non-Hodgkin’s lymphoma, and today it showed cancer doctors some evidence it hopes will convince them it’s a winner. The findings sent the company’s shares soaring by 47 percent in the last two hours of trading to close at $2.10.
The Seattle biotech company (NASDAQ: CTIC) reported results from a trial of 140 patients who were randomly assigned to get the company’s pixantrone, or another chemotherapy drug. Researchers found that the Cell Therapeutics drug boosted complete remission rates, had a greater ability to shrink tumors, and kept tumors from spreading a longer period of time, according to data presented today at the American Society of Clinical Oncology meeting in Orlando, FL. This is the biggest show for cancer drugs of the year, with more than 30,000 cancer doctors assembled to learn about state-of-the-art treatments.
The results stopped short, however, of showing with certainty that pixantrone could actually help patients live longer—the gold standard for evaluating cancer drugs. That data will require more follow-up time, and should be available by year-end, said company spokesman Dan Eramian. The company, which sold its one marketed drug earlier this year, is planning to submit the current data to the FDA by later this month. The clock is ticking for the company, and CEO James Bianco said earlier this year he is in the middle of a “high-wire act.” Cell Therapeutics has said it has enough cash left to operate into August, and it plans to ask the FDA for an expedited six-month review of its application, which is sometimes granted for therapies with life-saving potential. If the FDA agrees to speed things up, it could approve the drug by year-end.
The lead investigator of this trial, Ruth Pettengell of St. George’s Hospital at the University of London, wasn’t bashful in her interpretation of the data on pixantrone, which is a modified version of anthracycline that is supposed to be less toxic to the heart than other drugs in its class.
“Anthracycline-related drugs can be effective salvage agents in aggressive non-Hodgkin’s lymphoma, but our use of them is limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs,” Pettengell said in a statement. “These results represent a breakthrough … Next Page »
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