Abraxis Looks Promising in Lung Cancer War (ABII)
Abraxis BioScience, Inc. (NASDAQ: ABII) is one of the top biotech gainers this morning. The company announced that its key ABRAXANE met the primary endpoint in a Phase 3 trial for advanced non-small cell lung cancer.
The company’s randomized Phase 3 clinical trial comparing ABRAXANE, the company’s protein-bound paclitaxel, along with with a Taxol injection, in combination with carboplatin met the study’s primary endpoint. ABRAXANE showed a significant improvement in overall response rate compared to Taxol alone as a first-line treatment for advanced non-small cell lung cancer patients.
The 1,052 enrolled patient study as of July 2009 was at 102 centers. The company noted that NSCLC is 85% of lung cancer diagnosis and noted that more than 200,000 are diagnosed with lung cancer each year with about 159,000 deaths per year.
The study was assessed by independent radiologist review and is the subject of a special protocol assessment with the FDA. Abraxis further noted that the design, clinical endpoints and statistical data and analysis have been previously agreed upon by the FDA. In that regard it said that the FDA agreed that the demonstration of a statistically superior response rate of the ABRAXANE and carboplatin combination over the Taxol and carboplatin combination is sufficient for the company to submit a supplemental new drug application for approval of ABRAXANE in combination with carboplatin as a first-line treatment of advanced non-small cell lung cancer.
Abraxis is surging. Shares opened at $46.45 this morning after a $39.85 close yesterday. The stock has run further and is now up almost 28% at $50.95 on the day. The problem here is that volume is very thin despite a $2 billion market cap. The 52-week high is $57.60. The company is also under-followed by Wall Street and that makes information less reliable or less covered by investors.
Today will b a near-term volume record if it continues. There has only been one day this calendar 2010 where it had 300,000 shares or more trade. In 2009, its most active day was 240,000 shares.
JON C. OGG
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