[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 in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naive patients as a potential alternative to currently available standard anthracycline drugs.”
Some of the data presented at the ASCO meeting was already publicized in a November press release, and some was new. The trial, called Extend, found that 20 percent of patients randomly assigned to pixantrone were put into complete remission, compared with 5.7 percent who did that well in the control group. More than one-third of patients (37 percent) had their tumors shrink in the pixantrone group, compared with 14 percent in control group.
Patients who enrolled in this study were quite sick from the get-go, with half of them having their disease worsen after three prior rounds of chemotherapy, researchers said. More than 70 percent were considered to be at intermediate to high-risk status when graded by an International Prognostic score.
Patients in the pixantrone group had higher rates of white blood depletion, known as neutropenia, with 41 percent reporting a severe case of that effect on the drug, compared with 19 percent in the control group. A more severe form of that condition, febrile neutropenia, was found in 7.4 percent of pixantrone patients, compared with 3 percent in the comparison group. As we reported previously, there were also more cases of severe cardiac disorders in the group who got pixantrone—8.8 percent on the drug, compared with 4.5 percent in the control group.
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