WASHINGTON _ After meeting with officials with the NationalCancer Institute, Chiron Corp. decided to delay Phase III trials ofProleukin for ovarian cancer because the NCI wanted more data andwas concerned about the selection of study cohorts, Chiron officialssaid.

Instead, the company will launch a Phase II trial involving 40 to 50women with advanced ovarian cancer in September, according toLarry Kurtz, spokesman for Emeryville, Calif.-based Chiron.

Chiron on Monday met with NCI officials at the annual meeting ofthe American Society of Clinical Oncology in Los Angeles. NCIofficials expressed concerns that preliminary data released fromPhase I/II clinical trials of Proleukin were "good but not solidenough," Kurtz said.

The NCI was also concerned that launching Phase IIItrials would involve a significant number of women from a smallpatient population. Typically women with advanced ovarian cancerwho have failed traditional therapies are reticent to enroll in this typeof clinical study because it involves the intraperitoneal administrationof the anti-cancer drug, an often painful procedure, Kurtz said.

Because a Proleukin Phase III trial would have involved 100 to 200of these women for two years, the NCI "thought this would tie up thesystem too much," Kurtz told BioWorld Today.

Results from the Phase II trial will be available in about a year, Kurtzsaid. Data from the Phase I/II study released earlier this week showedthat 26.4 percent of the 34 advanced ovarian cancer patientsexperienced a complete or partial response to Proleukin.

Proleukin is a recombinant form of the natural interleukin-2 cytokine,already approved by the FDA for metastatic kidney cancer. Thepotential market for Proleukin among advanced ovarian cancerpatients would double the drug's market, now aimed at 10,000patients per year diagnosed with advanced kidney cancer. n

-- Michele L. Robinson Washington Editor

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