DepoTech Inc. and Chiron Corp., of Emeryville, Calif., plan to file anew drug application this year for their anti-cancer therapy based onPhase III results disclosed Tuesday.
DepoCyt, a sustained-release form of the chemotherapeutic agentcytarabine, produced better responses than standard therapy inpatients with neoplastic meningitis arising from solid tumors.Additional studies testing DepoCyt in patients with neoplasticmeningitis arising from lymphomas and leukemias are ongoing.
Edward Erickson, president and CEO of San Diego-based DepoTech,said additional statistical data from the solid tumor arm will becompiled over the coming months, with the filing of approvalapplications in the U.S. and Canada scheduled by year's end.
The companies also said Tuesday they started a Phase IV study ofDepoCyt in the solid tumor arm. Those studies usually are done afterproduct approval, but the timing was changed for this acceleratedcancer program dealing with a terminal disease. Neoplasticmeningitis is a form of cancer that occurs when metastases spread tothe soft tissue surrounding the brain or spinal cord. Interim results ofDepoCyt released last year showed increased response rates andsurvival vs. the standard therapy of methotrexate.
The complete solid tumor data released Tuesday showed nine of 25evaluable DepoCyt patients (36 percent) showed a completeresponse. In methotrexate-treated patients, five of 29 evaluablepatients (17 percent) had complete responses, which was defined inthis study as the absence of malignant cells in two consecutivesamples of cerebrospinal fluid and lack of disease progression.Partial responses were not measured.
Erickson said the FDA did not require statistical significance in thestudy because of the severity of the disease and difficulty in accruingenough patients to satisfy that requirement. Instead DepoCyt only hadto show it performed as well as methotrexate. If that is shownDepoCyt is better because it is injected once every two weeks ratherthan two or three times per week, offering convenience and quality-of-life benefits.
DepoTech's stock (NASDAQ:DEPO), taken public in September1995 at $12 per share, gained 13 cents Tuesday to close at $25.13.Chiron (NASDAQ:CHIR) was up 50 cents at $97.75. n
-- Jim Shrine
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