Clinical trial aims to confirm significant survival benefit seen in Phase II
Oslo, Norway, 18 August 2010
Clavis Pharma (OSE: CLAVIS), the Norwegian cancer drug development company, announces that it has recruited the first patient into its pivotal Phase III study assessing its lead product elacytarabine in patients with late-stage acute myeloid leukemia (AML).
Elacytarabine is a novel, patented, lipid-conjugated derivative of cytarabine, the current standard treatment for AML, and is developed using Clavis' lipid vector technology (LVT). It is designed to improve upon the efficacy of cytarabine by enabling the drug to enter cancer cells without requiring membrane expression of transporter proteins. The entry of cytarabine into tumour cells is dependent upon the expression of specific membrane transporter proteins, particularly hENT1. Elacytarabine has been granted orphan drug status for the treatment of AML in the US and EU.
The Phase III study (known as the CLAVELA study) is an open-label, randomised trial comparing elacytarabine with the investigator's choice of treatment in patients with late-stage AML (i.e. those who have failed two or three previous treatment regimes). The trial will recruit up to 350 patients at 65 sites in the USA and Europe.
The primary objective of the study is to compare overall survival (OS) between patients treated with elacytarabine and those treated with the investigator's choice. The secondary objectives are to compare the response rates, duration of response, and safety profile of elacytarabine with the investigator's choice treatments. In addition, the study aims to characterize the exposure-response relationships for elacytarabine as measures of effectiveness and toxicity.
Patients randomised to the investigators' choice group can receive a range of treatments including:
- High-dose cytarabine for up to six days
- MEC - mitoxantrone, etoposide and cytarabine
- FLAG or FLAG-IDA - fludarabine, cytarabine, G-CSF and idarubicin
- Low-dose cytarabine for up to two weeks
- Hypomethylating agents - azacytidine or decitabine
- Best supportive care
The company expects to complete patient recruitment late in the second half of 2011 and to report in the second half of 2012. The results from this study, if positive, will be used by Clavis Pharma to support regulatory filings in the USA and Europe.
The Chairman of the CLAVELA study's steering committee is Professor Francis J. Giles, Professor of Medicine, Cancer Therapy & Research Center at the University of Texas Health Science Center San Antonio, USA. Prof. Giles was also Coordinating Investigator of Clavis Pharma's Phase II study with elacytarabine, which concluded in 2009 and showed a statistically significant median survival benefit of 5.3 months compared to 1.5 months in published clinical data for late-stage AML.
Prof. Giles said: "This is a very important day in the search to find improved treatments for patients with AML. Previous studies have shown that elacytarabine has the ability to extend threefold the overall survival of AML patients for whom the prognosis is particularly bleak. The CLAVELA Phase III study is the most thorough and well designed study currently assessing a new agent in this patient group. I look forward to working with my fellow investigators to complete this study on schedule. I feel confident that elacytarabine will prove to be of real benefit to patients with AML and that the application of Clavis' LVT to other anticancer agents will bring further progress in AML and beyond. "
Olav Hellebø, CEO of Clavis Pharma, said: "The start of the CLAVELA study is a major milestone for Clavis Pharma. We have invested a great deal of time with the international investigator community and the regulatory authorities to design a pivotal Phase III study that will allow us to confirm the overall survival benefit that elacytarabine could deliver to patients with AML. The study will also enable us to assess the ability of our LVT platform to enhance gold standard cancer therapies, such as cytarabine, by improving their cellular uptake."
For further information:
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
olav.hellebo@clavispharma.com
Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum@clavispharma.com
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma@citigatedr.co.uk
About Clavis Pharma
Clavis Pharma ASA is a clinical stage oncology drug development company based in Oslo, Norway with a portfolio of novel anti-cancer
drugs in development. These patented New Chemical Entities (NCEs) are novel, improved versions of commercially successful
drugs, made using Clavis Pharma's Lipid Vector Technology (LVT) chemistry. Data generated suggests these potential breakthrough
products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue
penetration, altered metabolism and, in certain cases, additional modes of action.
Clavis Pharma's has several drug candidates in formal development studies:
- Elacytarabine, an optimised form of cytarabine, a leukaemia drug - currently in Phase III, a randomized, controlled registration study in late-stage acute myeloid leukaemia;
- CP-4126, an improved version of gemcitabine - currently in a Phase II comparative study with gemcitabine for the treatment of pancreatic cancer;
- CP-4200, an azacitidine derivative - in preclinical development for myelodysplastic syndrome (MDS), often a precursor to leukaemia.
Clavis Pharma intends to commercialise its products through strategic alliances and partnerships with experienced oncology businesses and, where and when commercially appropriate, by establishing its own sales and marketing capabilities. CP-4126 is licensed to Clovis Oncology in the Americas and Europe. Clavis Pharma has retained rights in other territories and an option to co-promote CP-4126 in Europe.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS).
Disclaimer
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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
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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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