Ribi To File For Melanoma Vaccine Approval

Ribi ImmunoChem Research is to file commercial product license applications for its Melacine melanoma therapeutic vaccine in the USA, Canada and the European Union in 1997, the company's president, chairman and chief executive, Robert Ivy, has told shareholders. If Melacine receives favorable regulatory review, it is likely to be the first off-the-shelf commercially-available cancer vaccine, according to Ribi.

The most recent analysis of the first pivotal Phase III study of Melacine, he said, showed essentially equivalent survival to an aggressive, experimental four-drug chemotherapy regimen (the Dartmouth Protocol) that is the apparent gold standard for therapy of late-stage, disseminated melanoma. Additionally, he revealed, the most recent data show that Melacine achieved a significant quality-of-life advantage over the Dartmouth Protocol during the treatment period. Melacine also significantly extends survival in the late-stage melanoma patient cohort compared to several other available therapies.

Mr Ivy added that Ribi is now working with the Canadian Health Protection Branch to prepare a New Drug Submission as soon as possible, and plans to review the final study with the US Food and Drug Administration and the European Medicines Evaluation Agency to determine the appropriate regulatory paths at those two agencies.