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Add Alfacell (ACEL) to Your List of Speculative Biotechs

Posted on Friday, October 5th, 2007 | In Biotech
Contributed by: Mike Havrilla (http://mikehav.blogspot.com/) -

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.

The Company recently announced it has confirmed that 290 evaluable events (patient deaths) have occurred in the Phase 3b trial of ONCONASE for the treatment of patients with unresectable malignant mesothelioma. The number of evaluable events was confirmed after the company learned that total events in the study had reached 316. In accordance with the statistical plan for the study, the company must wait until 316 evaluable events have occurred to conduct the formal statistical analysis required to complete the ONCONASE NDA.

The Company currently anticipates that 316 evaluable events will occur before EOY07 & plans on the following timetable for completion of its rolling NDA submission:

  • - report occurrence of 316 evaluable events via PR within 72 hours of confirmation by Alfacell
  • - if data are positive, submit final clinical section of rolling NDA within four months of reporting 316 evaluable events

-importantly, the Company believes that it has sufficient cash resources available to continue to fund the completion of the ONCONASE Phase 3 program & the rolling NDA submission –> making ACEL an “A” list candidate for speculative, micro-cap biotech investors

Last 5 posts by Mike Havrilla

Tags for this Post:
Biotech, biotech




About Mike Havrilla (http://mikehav.blogspot.com/)

The MikeHav Market Blog provides investors with a free source of stock profiles, tools, and commentaries focused on
carbon credits, the healthcare sector, exchange-traded funds (ETFs), and innovative companies across all industries.

I am a pharmacist and index developer who has been investing since August 1997 and freelance writing for investors since April 2007. I am also an avid runner since 1992 and have completed 18 marathons (26.2 miles) with a personal best time of 2 hours, 54 minutes.

I can be contacted via email at mikehavrx[at]yahoo[dot]com.

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