Press Release from Alfacell Corporation
Alfacell Provides Update on ONCONASE Phase IIIb Confirmatory Registration Trial; Releases First Interim Analysis Data
April 27, 2006
BLOOMFIELD, N.J., April 27 /PRNewswire-FirstCall/ -- Alfacell Corporation today announced that the 210 events (deaths) has been reached in its confirmatory Phase IIIb registration trial evaluating ONCONASE® (ranpirnase), the Company's lead investigational drug candidate, as a treatment for unresectable malignant mesothelioma (UMM). This number of events represents two-thirds of the required events for the study. The Company has the option to conduct a second interim analysis of the data at any point after 210 events (of the 316 total events planned).
Following the announcement of reaching full patient enrollment (February 2006), the Company today released results from the protocol-specified first interim analysis based on one-third of the required events (105 events of 143 patients) of the study, which evaluates the efficacy, safety and tolerability of the combination of ONCONASE + doxorubicin as compared to doxorubicin alone.
- The primary endpoint of the trial is overall survival. The overall
median survival time (MST) favored the ONCONASE + doxorubicin treatment
group (12 months) over the doxorubicin group (10 months). A two month
improvement in median survival had also previously been observed in
the Treatment Target Group (TTG) analysis (n=104) from the completed
Phase III single agent study that favored the ONCONASE group over doxorubicin
group (11.6 months vs. 9.6 months).
The confirmatory registration trial was designed based on the conclusions drawn from the TTG analysis, but powered to reach a statistically significant difference in MST between the ONCONASE + doxorubicin treatment group and the doxorubicin treatment group at 316 events. The first interim analysis was not designed to support filing for marketing approval with the FDA because the data at the time of the
analysis represented only one third of the planned number of events.
The interim data results, however, were sufficient for the Company to continue the trial as planned.
Other results of this interim analysis included:
- At one-year, 47% of the ONCONASE + doxorubicin-treated patients were alive as compared to 36% of the patients treated with doxorubicin.
- Patients evaluable for clinical response (those with evidence of tumor regression or stabilization of disease for a minimum of 3 months) showed a seven-month difference in the MST (17 vs. 10 months) favoring the ONCONASE + doxorubicin group vs. the doxorubicin group.
- The analysis of safety data revealed that ONCONASE when given with doxorubicin did not increase the number or severity of known doxorubicin-associated side effects. The most frequent side effects reported for both treatment groups included nausea, fatigue and alopecia. The incidence of these events was comparable for both treatment groups.
ONCONASE is a first-in-class therapeutic from Alfacell's proprietary ribonuclease (RNase) technology platform. ONCONASE has been shown to target tumor cells while sparing normal cells. ONCONASE is internalized by endocytosis and released into the cytosol of the cancerous cell, where it selectively degrades tRNA beyond repair. In doing so, ONCONASE inhibits protein synthesis, stops cell cycle proliferation, and induces apoptosis (programmed cell death).
ONCONASE has previously been granted Orphan Drug designation from EMEA and TGA (Australia), as well as Fast Track status by the FDA. The latter has enabled the Company to complete and submit sections of the New Drug Application (NDA) on an accelerated, rolling basis.
In addition to the Phase IIIb UMM registration trial, the Company is
conducting an ONCONASE Phase I / II trial in Non-Small Cell Lung Cancer
(NSCLC). The NSCLC market is expected to exceed $4 billion by 2012.