"Positive Phase II results in AML"
February 25, 2009
Clavis Pharma ASA (OSE: CLAVIS) announced today the results for the fourth quarter 2008, and reports that during the quarter the Company released positive interim clinical Phase II results for ELACYT (CP-4055) in patients with acute myeloid leukaemia (AML). As planned, R&D and other operating expenses totalled NOK 27 million for the fourth quarter and NOK 91 million for full year 2008. Cash and cash equivalents amounted to NOK 85 million at 31 December, 2008.
Highlights from fourth quarter 2008:
- In December 2008, positive data from the ELACYT (CP-4055) single agent clinical Phase II study in 2nd salvage acute myeloid leukaemia (AML) was presented at the American Society of Haematology Meeting. In this difficult-to-treat patient group, three of the first twenty patients achieved complete remission.
- The Phase I study of ELACYT in combination with idarubicin in AML has been completed. Recommended dose for Phase II has been established at 1000 mg/m2/day. Although the main objective of the study was to evaluate the safety and establish the recommended dose, positive and encouraging clinical benefits have also been recorded.
- The Company held an "End of Phase II meeting" with the US Food and Drug Administration (FDA) in November 2008. The FDA agreed in principle with the complete ELACYT haematology development plan towards a New Drug Application (NDA) in AML.
- The Company has in November 2008 obtained "Scientific Advice" from the European Medicines Agency (EMEA) for its clinical development programme for Intravenous CP-4126. This consulting procedure ensures that the Company's plans are according to EMEA's expectations for a future Marketing Approval Application (MAA) for the EU.
- The Company is exploring the development of a novel biomarker diagnostic method together with two research organizations and potential commercialization partners to enable the pre-selection of patients that respond poorly to current treatment but would benefit from treatment with ELACYT and CP-4126.
- The Company's R&D programs are progressing well, resulting in R&D and other operating expenses of NOK 27 million for the fourth quarter and NOK 91 million for 2008. The Company had cash and cash equivalents of NOK 85 million as of 31 December 2008.
Commenting on the fourth quarter report, the CEO of Clavis Pharma, Geir Christian Melen says:
"We have made good progress with our clinical program during the quarter, and are particularly excited with the results from the first 20 patients in our Phase II study in AML. The study is progressing well and we look forward to seeing the results from the remaining patients in the trial", he continues.
Contact:
Geir Christian Melen
Chief Executive Officer
Office : +47 24 11 09 50
Mobile : +47 91 30 29 65
E-mail : geir.christian.melen@clavispharma.com
Gunnar Manum
Chief Financial Officer
Office : +47 24 11 09 71
Mobile : +47 95 17 91 90
E-mail : gunnar.manum@clavispharma.com
About Clavis Pharma
Clavis Pharma ASA is an oncology focused pharmaceutical company using its proprietary Lipid Vector Technology (LVT) platform
to create New Chemical Entities (NCEs), by significantly improving already established drugs. The improvements are 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's objective is 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 into strategic partnerships with established pharmaceutical or biotech companies. The company's product portfolio includes four new cancer drugs: ELACYTTM is in Clinical Phase II, Intravenous CP-4126 is in Clinical Phase I, Oral CP-4126 in Phase I, and CP-4200 is in early preclinical development. Results indicate that these products have promising potential for several cancer indications within solid tumours and leukaemia.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS). Additional information on Clavis Pharma can be found at: http://www.clavispharma.com/.
Disclaimer
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be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful
prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction.
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
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