Matrix Pharmaceuticals Inc. has initiated Phase II trials of itsinjectable therapeutic implant for the treatment of prostate cancer,Craig McMullen, the company's president and chief executive,announced Wednesday at the Hambrecht & Quist Annual LifeSciences Conference in San Francisco.
The injectable gel delivers a local, controlled-release dose of 5-fluorouracil (5-FU) to cancerous prostate tissue. The drug is deliveredin a biodegradable protein matrix, which controls the rate of drugrelease, along with a vasoconstrictor to hold the drug in the tissue.
In what the company is calling a "limited" Phase II study, Matrix(NASDAQ:MATX) of Menlo Park, Calif., will seek histologicalconfirmation of the results from its Phase I/II dose escalation studyon the product, initiated in March 1992. Matrix said it expects toconclude enrollment in the Phase I/II trial at the end of this month.
In the Phase II trial, tumors from about 15 patients scheduled forsurgical removal of the prostate will first be injected with threeIntradose-FU Injection treatments over a period of six weeks. Inaddition to providing efficacy data, the subsequent excisions will givethe company information on drug distribution, safety andintraprostatic dose requirements. Matrix said it hopes to move toPhase III trials in 12 to 15 months.
Matrix is developing Intradose Injection products for cancers of theliver and head and neck, and superficially accessible tumors such asmelanoma, recurrent breast cancer and squamous cell carcinoma.Phase I/II trials for the head and neck and liver indications began inearly 1992; the accessible tumor protocol was added last August. Allthree trials concluded enrollment in December and are currently indata analysis. The company plans to go directly into "approval-directed" Phase IIb/III trials for these three indications in thesecond half of 1994 in the U.S. and Europe, according to a companyrepresentative. -- Karl A. Thiel
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