Diagnostic test to identify cancer patients who may benefit from
Clavis Pharma's novel cancer drugs
Oslo, Norway, April 22, 2010
Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, is pleased to note that Clovis Oncology, it's partner in the development and commercialisation of Clavis Pharma drug candidate CP-4126, and Ventana Medical Systems, Inc. have entered into a collaboration agreement to develop a companion diagnostic to CP-4126 (also known as CO-101) for clinical and commercial use. Ventana Medical Systems is one of the world's leading developers and manufactures of medical diagnostics.
The companion diagnostic is being developed to identify pancreatic cancer patients with low-level tumour expression of the human equilibrative nucleoside transporter 1 (hENT1) protein. Ultimately, the use of a hENT1 companion diagnostic will enable oncologists to identify patients who may show a significant benefit from treatment with Clavis Pharma's novel drug candidates.
The hENT1 transporter on tumour cells plays a crucial role in the uptake of cytotoxic nucleoside-based drugs and their low level or absence have been correlated to a poor clinical outcome to treatment with drugs such as gemcitabine and cytarabine. It is estimated that pancreatic tumours in up to two-thirds of patients have low levels of hENT1 on the tumour cell surface.
CP-4126, and other drug candidates in Clavis Pharma's portfolio, has been developed using its proprietary Lipid Vector Technology (LVT), which enables the compound to enter cancer cells independently of hENT1. CP-4126 is an LVT form of gemcitabine, the current standard treatment for advanced pancreatic cancer, and which is also used in combination with other chemotherapy agents for the treatment of other cancers, including ovarian, non-small cell lung, and breast cancer.
Olav Hellebø, Clavis CEO, commented: "We believe there are many cancer patients who are not receiving optimal treatment from nucleoside drugs because of low levels of the required transporter proteins on cancer cells leading to insufficient cellular uptake. Nucleoside drugs, such as gemcitabine and cytarabine, are long established as one of first lines of treatment and their effects are significantly diminished by low levels or absence of hENT1. We are therefore very pleased by the development announced today. This is a significant step in the development of CP-4126 in pancreatic cancer, and will allow our commercial partner Clovis Oncology to select patients that will have greatest benefit from treatment with CP-4126 in future clinical trials."
For further details, please see http://www.prnewswire.com/news-releases/clovis-oncology-inc-signs-an-agreement-with-ventana-medical-systems-to-develop-companion-diagnostic-test-for-co-101-91803299.html
For Further Information Contact:
For Clavis Pharma
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
+44 7833904901 (mob)
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 CP-4126
CP-4126 is a novel, patented, lipid-conjugated form of the well-established cancer drug gemcitabine (Gemzar®) that has the
potential to improve treatment outcomes in patients with pancreatic cancer as other solid tumours who have low levels of hENT1.
CP-4126 will shortly be directly compared to gemcitabine in an international, randomised, controlled trial in patients newly diagnosed with metastatic pancreatic cancer. The study will enroll approximately 250 patients, randomized between gemcitabine and CP-4126, and measures overall survival (OS) in prospectively-defined hENT1-low patients as the primary endpoint. Expression of hENT1 in tumour tissue will be measured during the trial and patients categorized into hENT1-high or hENT1-low groups prior to final analysis. This study is a prospective test of two hypotheses: (1) that low pancreatic tumor hENT1 expression is associated with poor outcome after gemcitabine therapy, and (2) that CP-4126 has superior efficacy (measured by OS) in hENT1-low patients compared with gemcitabine. This trial will commence enrollment in the second quarter of 2010, and data from this trial are expected in the first half of 2012.
CP-4126 has been granted orphan drug status for the treatment of pancreatic cancer in both the U.S. and the European.
About Pancreatic Cancer
Pancreatic cancer presents a major unmet medical need due to the poor survival outcomes and limited number of therapeutic
options available to patients. Approximately 37,000 new cases of pancreatic cancer were recorded in the US in 2007. The
1-year and 5-year overall survival rates are estimated at 23% and 4%, respectively. The majority of pancreatic cancer patients
are diagnosed with locally advanced (unresectable) or metastatic disease. Median overall survival in these advanced patients
is 4-10 months.
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 improved form of Ara-C, a leukaemia drug - about to commence a Phase III randomized, controlled registration study in late-stage acute myeloid leukaemia;
- Intravenous CP-4126, an improved version of gemcitabine - currently in a Phase II comparative study with gemcitabine for the treatment of pancreatic cancer;
- Oral CP-4126 - currently being evaluated in an escalating dose Phase I study in solid tumours; and
- CP-4200, an azacitidine derivative - in preclinical development for myelodysplastic syndrome (MDS), often a precursor to myeloma or 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
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 provided herein, and no claims shall be made by the recipient hereof by virtue of this News Announcement or the information contained herein.
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