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Clavis Pharma ASA (OSL:CLAVIS) "Three products in clinical development" Oslo, Norway, October 23, 2008
Clavis Pharma ASA (OSE: CLAVIS) announced today the results for the third quarter 2008, and reports that the Company entered clinical development with its third product, Oral CP-4126, during the quarter. In addition, the preliminary safety data from the first 20 patients in the Company's ELACYT clinical Phase II study in acute myeloid leukaemia confirmed that the safety profile of ELACYT is satisfactory. R&D and other operating expenses totalled NOK 24 million for the third quarter, while cash and cash equivalents amounted to NOK 106 million as of 30 September, 2008.
Highlights from third quarter 2008: - Oral CP-4126 has entered Phase I to evaluate the drug's safety and uptake of the active metabolite in the body. As the metabolite is a known anticancer agent, proof of concept may for Oral CP-4126 be obtained already in this Phase I study. This is the Company's third product in clinical development.
- Intravenous CP-4126 is currently undergoing evaluation to establish the recommended dose for Phase II. Promising data from the Phase I trial were presented at the European Society for Medical Oncology (ESMO) Meeting in September 2008.
- The ELACYT clinical Phase II study in acute myeloid leukaemia (AML) is progressing according to plan. An Independent Data Monitoring Committee has evaluated preliminary safety data from the first 20 patients. The committee's recommendation was to continue the study, confirming that the safety profile of ELACYT is satisfactory.
- The Company has filed two new patent applications regarding Oral CP-4126 and CP-4200 during the third quarter, thus broadening its intellectual property position.
- The Company's R&D programs are progressing well resulting in planned R&D and other operating expenses of NOK 24 million for the third quarter and NOK 65 million for the first nine months of 2008. The Company had cash and cash equivalents of NOK 106 million as of 30 September, 2008.
Commenting on the third quarter report, the CEO of Clavis Pharma, Geir Christian Melen says: "We are very excited having just started our first clinical trial with our first oral drug candidate. Having three drugs in clinical development, we are now looking forward to see the results that we are focused on generating in our ongoing clinical trials", he continues.
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: ELACYT(TM) 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 The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there 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.
No expressed or implied representations or warranties are given concerning Clavis Pharma or the accuracy or completeness of the information or projections provided herein, and no claims shall be made by the recipient
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