Oslo, Norway, 14 February 2008
On 11 February 2008, the Company announced that the maximum tolerated dose (MTD) had been determined in the Clinical Phase I/II with ELACYTTM in haematological cancers. Preliminary data shows promising safety and potential therapeutic activity in leukaemia. Great investigator enthusiasm is demonstrated through rapid patient enrolment.
This important milestone is a prerequisite for continuing the Phase II part of the study. ELACYT has shown a good safety profile for both regimens studied in the Phase I part of the study and the MTD was reached above the level where clinical activity was reported.
The Phase II combination study of ELACYT and NexavarTM (sorafenib) in malignant melanoma patients is progressing according to plan at six centres in Europe and the US. The ELACYT Phase II study in metastatic colorectal cancer is also progressing well and currently involves four sites in the UK.
The intravenous CP-4126 Phase I study in solid tumours is moving towards completion. The Phase II program will be designed as blinded randomized studies aimed at showing superiority over current treatment options in selected patient populations.
Preliminary data from the Oral CP-4126 preclinical safety study are very encouraging. Preparations for clinical trials are in progress.
The Company's R&D programs are progressing well resulting in R&D and other operating expenses of NOK 21 million. The Company maintains a sound cash position, with cash and cash equivalents of NOK 168 million as at 31 December, 2007.
For further information, please contact:
Tom Pike, CEO (
tom.pike@clavispharma.com
) or
Gunnar Manum, CFO (
gunnar.manum@clavispharma.com
)