Has Genta's Energizer Bunny of Cancer Drugs Finally Run Out of Juice?

The most surprising thing about last week’s Phase III failure of beleaguered cancer drug Genasense was that Genta’s stock (GETA.OB) fell 70 percent. Seriously, who didn’t see this one coming?

If there was an award for the number of setbacks a drug could possibly suffer, Genasense would have to be in the running. It’s been a long downhill slide since 2002, when Genasense was considered a wonder of antisense technology and the subject of a $480 million deal with Aventis (now of Sanofi fame). A quick trip through BioWorld’s archives reveals:

• Sept 2003: Phase III melanoma trial fails; Genta submits drug for FDA approval anyway
• May 2004: FDA advisory committee recommends against approval in melanoma; Genta withdraws filing
• June 2004: Expanded patient access program in melanoma discontinued
• Nov 2004: Phase III trial in chronic lymphocytic leukemia fails; Genta decides to try for approval anyway
• Nov 2004: Aventis backs out of partnership
• Nov 2004: Phase III trial in multiple myeloma fails
• Sept 2006: FDA advisory committee votes against approval of Genasense in CLL
• Dec 2006: FDA rules Genasense is not approvable in CLL; Genta appeals
• April 2007: European regulators give Genasense the thumbs down in melanoma
• March 2008: FDA denies CLL appeal and maintains that more data is needed; Genta reanalyzes data and tries again
• Dec 2008: FDA denies CLL approval again; Genta decides to appeal again
• March 2009: FDA rejects second CLL appeal
• Oct 2009: Second Phase III melanoma trial fails

And it looks like Genta isn’t throwing in the towel yet. The company emphasized in its press release that even though Genasense failed to hit the co-primary endpoint of progression-free survival or secondary endpoints of overall response rate and disease control rate, the co-primary endpoint of overall survival and the secondary endpoint of durable response rate were too early to evaluate. So they might yet be positive.

Why would anyone hold out hope at this point? Maybe some investors feel that with the stock at 17 cents, things can’t get much worse. Or maybe they believe in Genasense because it has shown good trends along the way, even if those trends fell short of statistical significance, and the latest trial passed a futility analysis for survival.

Or maybe they figure hey, this is biotech baby, where it can happen for Vanda, it can happen for Vermillion — it can happen for anyone.

Energizer bunny photo by Flickr user cjc4454, CC.