Title: ASCO: Onconase Demonstrates More Favorable Outcome
in Mesothelioma Than Does Doxorubicin URL:
http://www.pslgroup.com/dg/1D367E.htm Doctor's Guide May 25, 2000
BLOOMFIELD, NJ -- May 25, 2000 -- Alfacell
Corporation announced 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.
Alfacell's research and development
program is making a major scientific contribution to the overall body of
knowledge in malignant mesothelioma. Our clinical results represent independent
confirmation of the clinical importance of the CALGB-defined prognostic groups.
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. Alfacell is located in Bloomfield, New
Jersey, and the Company's common stock is traded in the over-the-counter market
under the symbol "ACEL."