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www.fdanews.com/articles/90610-data-published-on-caelyx-as-first-line-ovarian-cancer-treatment

DATA PUBLISHED ON CAELYX AS FIRST-LINE OVARIAN CANCER TREATMENT

February 20, 2007

Schering-Plough has announced the publication of a multicenter Phase II clinical trial in the February issue of Annals of Oncology, which found treatment with Caelyx (pegylated liposomal doxorubicin hydrochloride), in combination with carboplatin, to be highly effective in patients with advanced ovarian cancer that had been previously treated. This Caelyx combination regimen was also associated with lower side effects, including neurotoxicity, than standard taxane-plus-platinum chemotherapy regimens.

The overall tumor response rate of 63 percent shown by this Caelyx-platinum combination was associated with a complete response rate of 38 percent, a median survival of 32 months and a median progression-free survival of 9.4 months.

Standard therapy for recurrent ovarian cancer is a regimen containing paclitaxel and carboplatin. However, neurotoxicity is a significant cumulative side effect of taxane-containing chemotherapy regimens, and therefore there is a need for a non-taxane option, according to the company. The results of this trial show that the combination of Caelyx and carboplatin is similar to standard therapy and offers lower neurotoxicity rates than seen in earlier studies of taxane-platinum combinations.

"These results support further evaluation of Caelyx plus carboplatin in patients with advanced ovarian cancer," Robert Spiegel, chief medical officer and senior vice president of Schering-Plough Research Institute, said. "An international trial with Caelyx is under way to expand on these findings and to identify the optimal treatment regimen for patients with relapsed ovarian cancer."

Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride, a widely used cytotoxic agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors.

The drug is approved in the European Union for the treatment of advanced ovarian cancer in women who have failed first-line, platinum-based therapy.