Highlights from first quarter 2009:
- In March, the Company announced positive results from a second interim analysis of the elacytarabine (CP-4055) Phase II study in patients with late stage acute myeloid leukaemia (AML). Six out of 40 evaluable patients attained complete response, which is substantially higher than comparable published data for existing therapies in this difficult-to-treat patient group. Further details will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) on 30 May. Following the positive interim results, the Company is planning a pivotal Phase III study in this indication.
- Encouraging data from the Phase I study of elacytarabine in combination with idarubicin in AML 1st course failure patients was presented at the American Association of Cancer Research (AACR) 100th Annual Meeting on 21 April 2009 in Denver, USA. Following the positive results, the Company is currently initiating Phase II in this indication.
- Intravenous CP-4126 has entered clinical Phase II. This was announced by the Company on 16 April. The study will be in newly diagnosed (1st line) pancreatic cancer patients and the objective is to study efficacy of the drug and its relationship to the patient's nucleoside transporter (hENT1) status.
- The Company held a "pre-IND meeting" with the US Food and Drug Administration (FDA) regarding Intravenous CP-4126 in February. The FDA agreed in principle with the Company's plans to conduct Phase II and III trials in 1st line pancreatic cancer patients.
- The Company's R&D programs are progressing well, resulting in R&D and other operating expenses of NOK 20.9 million for the first quarter of 2009. The Company had cash and cash equivalents of NOK 66.5 million as of 31 March 2009.
Commenting on the first quarter report, the CEO of Clavis Pharma, Geir Christian Melen says: "The positive second interim Phase II results in AML is very encouraging, and with the start of our CP-4126 Phase II program we now have two products in clinical Phase II development. Both these events provide us with great comfort in our ongoing development of our assets", 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: Elacytarabine is in Clinical Phase II, Intravenous CP-4126 is in Clinical Phase II, Oral CP-4126 in Phase I, and 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 (ticker: CLAVIS).
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