Rhone-Poulenc Rorer Inc.'s Phase II trial of a colorectal cancer drug,CPT-11, showed a 20.5 percent response rate, good enough to resultin the company submitting registration packages in two countries.

The Phase II trial enrolled 213 patients who previously had notreceived chemotherapy, or who had received 5-fluorouracil, thestandard treatment. Patients had advanced or inoperable locallyadvanced cancer.

Of 156 evaluable patients, four exhibited a complete response and 28showed a partial response, the company said. The median duration ofresponse was 9.1 months.

Bob Pearson, executive director, product communications for theCollegeville, Pa., company, said Rhone-Poulenc Rorer has submittedfor marketing approval in France and Spain. He told BioWorld thatsubmissions throughout Europe will follow.

CPT-11 (ironotecan) inhibits topoismerase I, an enzyme essential forcell division. The drug is a water soluble semisynthetic analogue ofcamptothecin, a natural compound originally isolated from a Chinesetree (capmtotheca acuminata). The Upjohn Co., of Kalamazoo,Mich., is developing CPT-11 in North America.

Pearson said development plans for CPT-11 are similar to those thecompany is using for Taxotere, which is approved in Mexico and justgot approval in South Africa to treat breast and non-small cell lungcancers. Rhone-Poulenc Rorer filed for Taxotere approval in morethan 30 countries.

Pearson said the next step for CPT-11, in conjunction with seekingmore European approvals, is to test it in combination with otherdrugs. _ Jim Shrine

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