Tumor cells should not necessarily be viewed as 'alien invaders' that must be killed in order to cure the host harboring them. Rather, the successful re-regulation of their growth, even without total tumor eradication, could provide much greater overall benefit to the host. Therefore, the criteria for a meaningful evaluation of clinical benefit of cancer treatment must be re-assessed, and the length of survival and its quality should be considered the two most important parameters. Tumor cells differ from the normal 'self' counterparts only in certain respects, often very narrowly, and primarily with regard to the de-regulation of cell growth and proliferation. The potentially reversible overall malignant phenotype is manifested by the growth largely independent of external factors, increased invasiveness, loss of contact inhibition, and development of the metastatic capabilities. This phenotype evolves in time and represents an inherently heterogeneous process. ONCONASE(R), a novel RNase from the eggs of the leopard bb frog (Rana pipiens) has demonstrated, both pre-clinically in vitro and in vivo as well as in clinical trials, a broad spectrum of anti-cancer activity. The favorable safety profile (e.g., lack of myelosuppression), broad spectrum of anti-cancer activity, synergistic interactions with multiple drugs, and the ability to induce apoptosis and to overcome multiple drug resistance, make ONCONASE(R) especially attractive as a re-regulator of the cancerous growth.

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