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Nov 19, 2012
 |  BioCentury  |  Product Development

Clavis counting on PK

After CO-101 blowup, Clavis hopes elacytarabine produces Phase III win in 1Q13

The pivotal failure of CO-101 from Clovis Oncology Inc. and Clavis Pharma ASA led investors to hammer both stocks, as the U.S. company lost its lead program, which used Lipid Vector technology from its Norwegian partner. But the outcome may be more a reflection of the failure of the biological hypothesis underlying that particular trial than of the technology itself.

As a result, Clavis hopes its second shot on goal, elacytarabine, still can succeed in Phase III because of a significant pharmacokinetic advantage over the parent drug.

Clavis shares fell NOK58 (88%) to NOK8 on Nov. 12, the day the partners announced CO-101 (CP-4126) had missed the primary endpoint in the pivotal Phase II LEAP trial in pancreatic cancer. CO-101, along with Clavis' two other programs, elacytarabine and CP-4200, use Lipid Vector technology, which attaches a free fatty acid to a molecule to make it more lipophilic.

Clovis, which lost $8.99 (42%) to $12.50 on the day, gained North and South American and European rights to the lipid-conjugated form of gemcitabine in 2009 and worldwide rights under an expanded 2010 deal (see BioCentury, Dec. 21, 2009).

Clavis...

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