Cell Therapeutics Lymphoma Drug Wipes Out Tumors in Pivotal Trial
Cell Therapeutics may just have one last chance to dig itself out of its hole. The Seattle-based biotech company said its experimental drug for non-Hodgkin’s lymphoma, pixantrone, was able to completely wipe out tumors for one-fifth of patients in a clinical trial, compared with about 6 percent who did that well on standard chemotherapy.
The study of 140 patients found that 14 of 70 (20 percent) of patients on pixantrone, with relapsed, aggressive forms of the disease, saw their tumors completely disappear. That compared with 4 out of 70 (5.7 percent) on the standard chemotherapy, the company said in a statement. Complete information on the drug’s side effects wasn’t reported, and full data on the trial, called Extend, will be reported at an upcoming scientific meeting. Cell Therapeutics plans to ask for a meeting with the FDA to discuss filing an application to market the product in early 2009.
The positive result for pixantrone comes at a rock bottom point for Cell Therapeutics (NASDAQ: CTIC). The company has seen its stock drop 80 percent this year, closing yesterday at 33 cents. Its sole marketed product, Zevalin, generated $2.6 million in sales in the third quarter, while it had an operating loss of more than $17 million. The company has said it is running dangerously low on cash, saying it needs more by the end of the year. Although many investors surely have written off the stock, data like this from pixantrone will be hard to ignore for pharmaceutical partners. The American Cancer Society estimates that 66,000 people will be diagnosed with non-Hodgkin’s lymphoma in 2008.
“This positive phase III study is validation of Cell Therapeutics’ capabilities in acquiring attractive drug candidates, and designing and implementing a successful phase III trial,” said James A. Bianco, the company’s CEO, in a statement.
Cell Therapeutics obtained pixantrone for $236 million back in June 2003, when it acquired Italy-based Novuspharma. The drug is a modified version of an anthracycline, designed to be less toxic to the heart than other drugs in its class. Whether it can really achieve these high rates of tumor shrinkage with milder side effects is a big question that isn’t answered in today’s release, but the shareholders, at least those who are left, will stick around to get the full picture.