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Clavis Pharma ASA (OSL:CLAVIS) Clinical development of ELACYT in haematology expanded
Oslo, Norway, 22 August 2008: Clavis Pharma presents today results for the second quarter and first half-year 2008, and reports an expansion of the ELACYT(TM) clinical programme in haematology during the second quarter. Promising results were demonstrated for the Oral CP-4126 programme, and a clinical phase I study in cancer patients will be started later this year. In addition, the Intravenous CP-4126 program has progressed towards start of clinical Phase II studies. R&D and other operating expenses totalled as planned NOK 40 million for the first-half of 2008 while cash and cash equivalents amounted to NOK 127 million as at 30 June, 2008.
Highlights from first half-year of 2008:
§ Dose limiting toxicity has been observed in the Intravenous CP-4126 dose escalating Phase I study. The study continues in order to establish the recommended dose for Phase II.
§ In June pre-clinical studies, demonstrating that Oral CP-4126 acts as a very efficient pro-drug for gemcitabine (Gemzar®), were finalized. The next step in the development of Oral CP-4126 will be the initiation of a Phase I study in cancer patients later this year. This will be the Company's third product in clinical development.
§ Clavis Pharma announced in June that the US Food & Drug Administration (FDA) had granted orphan drug designation to ELACYT for the treatment of Acute Myeloid Leukaemia (AML).
§ An ELACYT clinical Phase II study in acute myeloid leukaemia (AML) was initiated in April, and in June a Phase I study of ELACYT in combination with idarubicin was initiated. In line with this strengthening of the haematology program, the Company announced in July that the ELACYT clinical program moving forward will be focused primarily on haematological cancers.
§ In March a new clinical Phase II study with ELACYT in ovarian cancer was initiated. The objective of the study is to explore a more intense dosing regimen compared to the regimen applied in other ELACYT Phase II studies in solid tumours. Following an evaluation of all clinical data available it was decided in July to suspend further enrolment of patients in the colorectal cancer and the malignant melanoma studies, awaiting the outcome of the more intense dosing regimen in ovarian cancer.
§ Geir Christian Melen assumed his new position as Chief Executive Officer (CEO) of Clavis Pharma on 1 April 2008. The previous CEO, Tom E. Pike, has been elected a new Board Member and he continues to spend a significant part of his time as advisor to Clavis Pharma.
§ The Company's R&D programs are progressing well resulting in planned R&D and other operating expenses of NOK 19 million for the second quarter and NOK 40 million for the first half-year 2008. The Company had cash and cash equivalents of NOK 127 million as at 30 June, 2008.
Commenting on the second quarter report, the CEO, Geir Christian Melen says:
"We have made significant progress in our development of ELACYT in haematology during the first half of 2008 resulting in an expanded clinical haematology program. Furthermore, we are very pleased with the positive Oral CP-4126 results and we are now looking forward to start our first clinical study with this promising drug candidate. We are also pleased to see that our Intravenous CP-4126 program has made one important step closer to start of clinical Phase II trials."
The full report for the second quarter and first half-year 2008, together with an investor presentation, are available on www.clavispharma.com.
Contacts: Geir Christian Melen, CEO Office : +47 24 11 09 65 Mobile : +47 91 30 29 65 E-mail : geir.christian.melen@clavispharma.com
Gunnar Manum, CFO 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, of which the first ELACYT(TM) , is in Clinical Phase II, the second, I.V. CP-4126, is in Clinical Phase I, and the third, Oral CP-4126 is about to start in Clinical Phase I and the forth, CP-4200, is in 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, with the ticker CLAVIS. Additional information can be found at: www.clavispharma.com.
