May 23, 2000–Alfacell Corporation announced today that preliminary survival results of our Phase III trial were presented at the 90th annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, LA by Nicholas Vogelzang, M.D., Fred Buffet Professor of Medicine and Director of the University of Chicago Cancer Research Center, Chicago, Illinois.
Preliminary survival results from the Phase III clinical trial of ONCONASE® vs. doxorubicin in patients with unresectable malignant mesothelioma revealed ONCONASE®-treated patients demonstrated a more favorable survival outcome compared to doxorubicin-treated patients in the Treatment Target Group (TTG).
The median survival time (MST) for ONCONASE treated patients was 11.6 vs. 9.6 months for doxorubicin-treated patients. Several ONCONASE®-treated patients experienced long-term survival benefit.
The TTG was developed from the Cancer and Leukemia Group B (CALGB)-defined prognostic groups for patients with unresectable malignant mesothelioma. Patient classification according to these 6 prognostic groups allowed for the evaluation of comparable patient populations. The survival profiles of comparable TTG populations in the Phase III and previously conducted Phase II trial were very similar, confirming the importance of the CALGB classification of prognostic groups to be used prospectively when evaluating treatment modalities in this patient population.
To date, over 200 patients with unresectable malignant mesothelioma have been treated with ONCONASE®, and it appears to be well-tolerated. More importantly, there was no evidence of cardiac toxicity or life-time exposure limit as with doxorubicin or other anthracyclines.
These results indicate the potential usefulness of the CALGB prognostic groups for prospective evaluation of new treatments. Alfacell is targeting the TTG population in its evaluation of ONCONASE® + doxorubicin vs. doxorubicin in its ongoing trial for patients with unresectable malignant mesothelioma.
“ONCONASE®, is a non-myelosuppressive agent which has no apparent toxicity to vital organs, and has not been associated with any drug-related deaths.” stated Dr. Nicholas Vogelzang, “It has activity against malignant mesothelioma and since there is no approved treatment for this devastating disease, has been greeted with great interest by physicians, patients and their families.”
Alfacell Corporation is a leader in the research and development of RNases for therapeutic applications. ONCONASE, an anti-tumor agent is currently being investigated in Phase III clinical trials in patients with unresectable malignant mesothelioma
Note: Onconase is the brand name for ranpirnase.