Oslo, Norway, 15 June 2007
Clavis Pharma (OSE: CLAVIS) presented an update of data from its ongoing clinical Phase I/II study with ELACYT in hematologic cancers during a poster session at the Annual Meeting of the European Hematology Association (EHA) in Vienna on 11 June 2007. ELACYT is a novel cytotoxic agent in development for the treatment of hematologic cancers as well as for solid tumours. In this ongoing Phase I/II study Clavis Pharma reports that patients with hematologic malignancies have tolerated ELACYT well at doses up to 1150 mg/m²/day (2 hour infusion) and 675 mg/m²/day (continuous infusion). Initial results from this study were presented at AACR in April this year.
The phase I/II study is currently in its dose escalating phase with the aim to define the maximum tolerated dose, the optimal regimen and to characterize the safety profile of ELACYT given as a single agent in patients with hematologic malignancies. The second part of the study will evaluate the effect of ELACYT.
"The updated clinical results confirm the good safety profile seen with ELACYT so far" says Tom Pike, CEO of Clavis Pharma. "The progress of the study shows excellent recruitment in both continents and we hope to be able to open the phase II part shortly."
The centres involved in this multicentre Phase I/II study are MD Anderson Cancer Centre, Houston, Texas, USA, Institute Paoli Calmettes, Marseille, France and Duke University Hospital, USA. A number of new sites have been recruited for the Phase II - efficacy part of the study. The Co-ordinating Investigator of the study is Professor Frank Giles, Chief, Division of Hematology and Medical Oncology, University of Texas Health Science Center at San Antonio
Contact:
Tom Pike
Chief Executive Officer
Tel: + 47 915 19 652 / + 47 24 11 09 50
tom.pike@clavispharma.com
www.clavispharma.com
About Clavis Pharma
Clavis Pharma ASA
is a public oncology focused pharmaceutical company leveraging its proprietary Lipid Vector Technology (LVT) platform to
create New Chemical Entities (NCEs) by significantly improving approved drugs. The improvement is achieved by chemically binding
specific unsaturated lipids to existing, and well understood, approved pharmaceuticals. Data generated suggests the resulting
patentable NCEs offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue
penetration and, in many cases, additional modes of action.
Clavis Pharma intends to develop its drug candidates until significant value has been created and proof of principle in man
has been shown. For further clinical development and commercialisation of the products, Clavis Pharma will enter strategic
partnerships with established pharmaceutical or biotech companies. The company's product portfolio includes three new cancer
drugs, of which the first
ELACYTTM
, is in clinical phase II, the second, CP-4126, is in clinical phase I, and the third is in the pre-clinical phase. Results
indicate that ELACYT has a promising potential for several cancer indications within solid tumours and leukaemia.
Clavis Pharma ASA is listed on the
Oslo Stock Exchange
(ticker: CLAVIS). Additional information on Clavis Pharma can be found at:
www.clavispharma.com
About Leukaemia
Approximately 300,000 new cases in leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia
represents a market with high unmet medical needs. The high unmet medical need may open for accelerated approval pathways
to expedite market access for new drugs. It is a segmented market covering a broad variety of disorders. A major clinical
concern is the high rate of disease reoccurrence. The five-year survival for the most common acute leukaemia type, acute myeloid
leukaemia, (AML) is in the range of 5-10% for treated elderly patients (the majority receive no specific anti-AML therapy)
and is about 30% in treated younger adults.
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