Ribi ImmunoChem Research Inc. announced that it hasconcluded patient accrual in a pivotal, controlled Phase IIIclinical trial of Melacine melanoma therapeutic vaccine inpatients with disseminated melanoma (stage IV).
Overall, 70 patients were treated with the vaccine, whichincorporates Ribi's adjuvant Detox with a human melanomatumor cell lysate, explained Jeffrey McDowell, Ribi's corporateinformation manager. Another 70 patients were treated with achemotherapy regimen (which included the drugs DTIC,cisplatin, BCNU and Tamoxifen given per the Dartmouthprotocol). Patient accrual for these trials began in lateDecember 1991.
Because Melacine is intended to provoke an active immuneresponse against melanoma by a patient's own immune system,Ribi of Hamilton, Mont., designed the Phase III trial todetermine if treatment with the putative vaccine offersadvantages in survival and quality of life compared withchemotherapy.
Apparently, life extension and quality of life have beenrecognized by a joint FDA-National Cancer Institute committeeas valid measurements in clinical testing of cancer therapeutics.Ribi (NASDAQ:RIBI) will perform an interim analysis regardingboth points in nine months, McDowell said. "This is the mediansurvival time for the chemotherapy group," he added.
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