Onconase is currently being evaluated in an international Phase 3b registration trial in patients suffering from inoperable malignant mesothelioma, and it was granted an orphan drug designation by the FDA for this indication in January. The primary endpoint of the trial is overall survival. The first interim analysis results based on one-third of the required events (deaths) of the study -- which evaluates the efficacy, safety and tolerability of the combination of Onconase plus doxorubicin as compared to doxorubicin alone -- have been reported and were sufficient to continue the trial as planned. The overall median survival time demonstrated a trend favoring the Onconase plus doxorubicin treatment group (12 months) over the doxorubicin group (10 months).
The company recently reported in SEC filings that it has about $8 million in cash and investments, providing sufficient liquidity to fund operations through the end of July 2008. It is pursuing late-stage clinical trials for Onconase in malignant mesothelioma ($300 million global market) and earlier stage trials for non-small cell lung cancer (over $1 billion global market). I believe the survival benefit trends observed in the interim analyses for Onconase plus doxorubicin will lead to a statistically significant survival benefit for the drug compared to standard treatment with doxorubicin alone when the required 316 events are reached some time in third quarter, making Alfacel a buy in the $2 per share range for speculative biotech investors.
ACEL 1-yr chart