Clavis Pharma ASA (NO) - Promising Elacytarabine Clinical Results Presented at AACR
Oslo, Norway, 22 April 2009 --Clavis Pharma ASA (OSE: CLAVIS) presented results from its elacytarabine Phase I combination study in patients with acute myeloid leukaemia (AML) at the American Association of Cancer Research (AACR) 100th Annual Meeting 2009 in Denver, USA. The poster presentation was held on 21 April 2009.
Elacytarabine is a novel cytotoxic agent, and is an analogue of cytarabine - the backbone of therapy in acute leukaemia. Unfortunately a substantial portion of AML patients have a deficient uptake of cytarabine in their leukaemic cells due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the cell membrane. Cellular uptake of elacytarabine in contrast to cytarabine is independent of hENT1, which offers a potential clinical advantage to elacytarabine in the treatment of AML.
In the Phase I study elacytarabine was given in combination with idarubicin, an anti-leukaemia drug commonly used in combination with cytarabine. Elacytarabine was given at doses 1000 and 1150 mg/m2/day to 15 patients with AML. The maximum tolerated dose was 1150 mg/m2/day when administered as continuous infusion for 5 days in combination with a fixed dose of idarubicin, 12 mg/m2/d, given days 2 to 4. Toxicity was manageable and the dose limiting toxicities were typhlitis and hand-foot-syndrome. The recommended Phase II dose was determined to be 1000 mg/m2/d. Clinical activity was observed and four of 10 patients treated at the recommended Phase II dose were reported with complete remissions (CR/CRp).
Following the positive Phase I data, a Phase II combination study is in preparation in patients with early stage AML who have failed a first course of cytarabine based therapy. This is a patient group with an unfavourable prognosis for whom better therapeutic alternatives are needed. The purpose is to study response rates (CR + CRp) to the combination therapy and the relationship of the response rate to the patient's nucleoside transporter (hENT1) status. The objective is to demonstrate that the efficacy of elacytarabine is independent of the patient's hENT1 status. The study will involve approximately 10 major cancer centres in the USA and Europe.
"The results presented at AACR from our first Phase I combination study in AML are most encouraging." says Geir Christian Melen, CEO of Clavis Pharma. "We are looking forward to continue with a Phase II study in first course failure patients where efficacy of elacytarabine in combination with idarubicin will be further evaluated. This program complements very well our ongoing elacytarabine single agent program in late stage AML patients where we recently released positive Phase II interim data".
The centres recruiting in the Phase I were MD Anderson Cancer Center (MDACC), Houston, Duke University Hospital, Durham, and University of Texas Health Science Centre (UTHSC) at San Antonio, all in the USA. Elacytarabine has previously been granted orphan drug designation by both the FDA and the European Commission for the treatment of AML. Elacytarabine is proposed by the World Health Organization as the international non-proprietary name [pINN] for CP-4055. The proposal is supported by the United States Adopted Name Council.
 Hubeek et al, Br J Cancer 2005 and Galmarini et al, Leukemia Research, 2002
Contact: Geir Christian Melen Chief Executive Officer Office : +47 24 11 09 50 Mobile : +47 91 30 29 65 E-mail : firstname.lastname@example.org
Gunnar Manum Chief Financial Officer Office : +47 24 11 09 71 Mobile : +47 95 17 91 90 E-mail : email@example.com
About Elacytarabine and nucleoside transporter (hENT1) Clavis Pharma's lead product candidate elacytarabine (CP-4055) is a patented Lipid Vector Technology (LVT) version of the gold standard leukaemia drug, cytarabine. Elacytarabine has in clinical Phase I studies shown activity in haematological malignancies and a variety of solid tumours, and has shown superior activity over the parent drug cytarabine in many different preclinical tumour models. One important characteristic of elacytarabine is its independence of a certain cellular uptake mechanism (a specific nucleoside transporter, hENT1) whereas cytarabine is dependent on this transporter for entry into the cell. Many patients have low expression levels of this specific cellular uptake mechanism and a low level is known to be associated with poor outcome of treatment of AML with cytarabine (Hubeek et al, Br J Cancer 2005 and Galmarini et al, Leukemia Research, 2002).
About Leukaemia Approximately 300,000 new cases of leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia represents a market with high unmet medical needs, which may open for accelerated approval processes 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 recurrence. 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, and approximately 30% for treated younger adults.
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[pINN] is in Clinical Phase II, Intravenous CP-4126 is in Clinical Phase II, 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).
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 hereof by virtue of this Information Memorandum or the information or projections contained herein. Any representations or warranties made to an investor in Clavis Pharma will be subject to separate sale and purchase agreements to be negotiated between the parties.
Clavis Pharma(TM) is a registered trademark of Clavis Pharma ASA.
Posted: April 2009