Clavis Pharma Second Quarter and First Half Report 2011

Clavis Pharma ASA; the Norwegian cancer drug development company, has announced its results for the second quarter and the first half 2011 (three and six months ended June 30, 2011).

Highlights
• In February, Clavis Pharma and Clovis Oncology expanded the LEAP study, evaluating CP-4126 vs. gemcitabine in pancreatic cancer patients, from 250 to 360 patients, in order to increase the statistical power of the study from 80% to 90%. The new enlarged study now has the patient numbers for it to be a pivotal trial for registration.

• The retrospective observational analysis of hENT1 expression in pancreatic cancer patients to define the criteria for low and high hENT1 levels (study 002) is on track for defining a hENT1 cut off in Q4. This cut off will be used for analysis of data from the LEAP study.

• An open-label Phase II study of CP-4126 in pancreatic cancer patients, who are refractory to gemcitabine treatment, and where the resistance is likely to be due to impaired drug entry into tumour cells (study 003) began in February 2011, is on track. A decision to continue the trial with the second cohort of patients is expected in Q4, pending results from the first cohort.

• The Company has been awarded a grant from The Research Council of Norway of up to NOK 14 million (USD 2.5 million) to develop a flow cytometry assay for the detection and quantification of hENT1 in patients suffering from acute myeloid leukaemia (AML).

• Clavis Pharma and Translational Therapeutics, Inc. entered into a strategic licensing agreement regarding the development and commercialization of CP-4033 in the treatment of aggressive thyroid cancer and potentially other solid tumours. CP-4033 is a patented, Lipid Vector Technology (LVT) derivative of ribavirin currently in the preclinical stage of development.

• Dr. Robert J. Spiegel, MD, the former Chief Medical Officer at Schering-Plough (now Merck & Co.), was elected to the Company’s Board of Directors at the annual general meeting in May 2011 bringing extensive clinical development experience in the biotechnology and pharmaceutical industry.

• Research and development costs and other operating expenses amounted to NOK 43 million for the second quarter and 92 million for the first six months of 2011.

• Clavis Pharma raised NOK 21 million in January from a subsequent share offering following a successful private placement that raised NOK 154 million in November 2010.

• The Company had cash and cash equivalents of NOK 290 million at 30 June 2011.

Post-period Events
• Encouraging interim efficacy data were reported on 17 August from the Phase II clinical trial with elacytarabine in combination with idarubicin in patients with early stage AML who have failed cytarabine (ara-C)-containing first-course chemotherapy.

The interim results showed a complete remission (CR/CRi) rate of close to 50% independent of the patients’ hENT1 status. In addition, a correlation between hENT1 status and clinical responses to first-line cytarabine-containing therapy was seen, supporting the potential of hENT1 assessment as a means of identifying AML patients who are likely to benefit from elacytarabine-containing therapy.

• The Company announces today (see separate release) that it has decided to expand the pivotal Phase III CLAVELA study, investigating elacytarabine in patients with late-stage AML, in order to increase the statistical power of the study from 80% to close to 90%. The primary endpoint of survival will now be evaluated after 300 events have occurred vs. 250 events previously planned. The inclusion criteria have also been amended, significantly expanding the potential first launch patient population. Top line data are now expected to be available in Q4 2012.

• The Company has decided to delay the start of the clinical Phase I of CP-4200 in order to focus resources on the enlarged CLAVELA study.

• In July, the Company appointed Nicholas Adams as new Chief Business Officer. Mr Adams has more than 23 years of experience in the healthcare industry, including 12 years as VP Business Development at UK based Antisoma plc.

Olav Hellebø, Clavis Pharma CEO, commented: "We have this year progressed and strengthened our clinical development program to maximize the chances of having two novel compounds emerge successfully by the end of 2012.”