Cell Therapeutics, looking to confirm one of the few positive results from earlier clinical trials of its cancer drug Xyotax, said it will...
Cell Therapeutics, looking to confirm one of the few positive results from earlier clinical trials of its cancer drug Xyotax, said it will study the treatment in 600 women beginning later this month.
The study would be the first gender-specific international trial the company knows of for evaluating the impact of estrogen on how the body metabolizes chemotherapy. Estrogen is a category of female sex hormones.
The study would enroll women with lung cancer at about 170 sites in the U.S., Eastern Europe and elsewhere, Chief Executive Dr. James Bianco said during the Seattle company’s third-quarter conference call Monday.
Three earlier Xyotax studies didn’t reach their primary goals of showing the drug improves survival compared with standard chemotherapy, but they found women responded better to the drug than men. The earlier studies weren’t looking for a gender-specific outcome.
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Dr. Gary Goodman at the Swedish Cancer Institute in Seattle said gender-specific cancer treatment is a controversial area that hasn’t received much study, and the data that does exist is contradictory. Women tend to survive lung cancer longer than men, but there are several possible explanations, including hormones, he said.
Cell Therapeutics hopes to have interim results from the latest study to coincide with its application to the Food and Drug Administration for approval of Xyotax, expected during the second half of 2006.
Punk Ziegel analyst Matt Kaplan said regulators will have to clarify what kind of data Cell Therapeutics will have to show for gender-specific approval.
“Some of the pieces are falling into place, but I think it’s still a pathway that needs to be validated through the FDA,” said Kaplan, who owns shares of Cell Therapeutics and has a “market perform” rating on the stock. “It’s by no means a slam-dunk.”
The company reported a smaller third-quarter loss Monday mainly because it booked $30.5 million in one-time revenue from the sale of its leukemia drug Trisenox to Cephalon. But unloading the drug also erased $7.2 million in sales.
Cell Therapeutics plans to recognize an additional $39 million from the Trisenox sale in the fourth quarter, reflecting the period of a transition agreement that was part of the deal.
The company reduced costs by $8.9 million through layoffs — it has cut its U.S. work force by almost two-thirds to 107 this year — and by refocusing its business on Xyotax and another cancer treatment, pixantrone.
It expects to spend $66 million to $72 million in 2006 and had $41 million in cash and equivalents on Sept. 30. Earlier this month, it completed an $82 million convertible-notes offering.
Its stock closed down 3 cents Monday at $2.35.
Benjamin J. Romano: firstname.lastname@example.org
|Dollar figures in thousands, except per share; parentheses denote losses.|