Clavis cancer news

Clavis said it is undergoing a "significant down scaling" of its operations following the discontinued development of elacytarabine to treat acute myelogenous leukemia in April. Clavis said most of the employees will leave the company by the end of this year, including CEO Olav Hellebo, who is leaving effective May 20. Clavis said it expects operating expenses for the remainder of 2013 to be NOK34-NOK38 million ($5.8-$6.5 million), compared with NOK147 million ($25.1 million) for the same period last year. At March 31, Clavis had NOK169.9 million ($29 million) in cash and a three-month operating loss of NOK75.1 million ($12.8 million). Clavis had a 2012 operating loss of NOK104 million ($18.7 million). Clavis said it is still evaluating strategic alternatives, but declined to disclose details (see BioCentury, April 8).

The company discontinued elacytarabine after it missed the primary endpoint of improving median overall survival (OS) in the Phase III CLAVELA trial in 380 patients with relapsed or refractory AML. In April, the company said it will evaluate next steps, including a sale to a public company, a reverse merger with a private company or a managed closure. Elacytarabine, a Lipid Vector Technology (LVT) derivative of cytarabine (Ara-C), has Fast Track and Orphan Drug designations in the U.S., and Orphan Drug designation in the EU to treat AML. ...