First patient enrolled in a clinical study with CP-4126 in combination with cisplatin in non-small cell lung cancer

First patient enrolled in a clinical study with CP-4126 in combination with cisplatin in non-small cell lung cancer

Oslo, Norway, August 8, 2012

Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, announces that a Phase I study of CP-4126 (CO-101) in combination with cisplatin in non-small-cell lung cancer (NSCLC) has been initiated by its partner Clovis Oncology. The first patient has now been dosed in this two-part study, which is being conducted at cancer centres in the USA and the UK.

The combination of cisplatin and gemcitabine has been shown to be an effective regimen for solid tumours including NSCLC. However, entry of gemcitabine into tumour cells has been shown to be dependent on specific membrane transporter proteins, particularly human equilibrative nucleoside transporter 1 (hENT1). As a result, patients with low tumour hENT-1 expression may respond poorly to gemcitabine-containing treatment regimes.

CP-4126 is a fatty acid derivative of gemcitabine developed using Clavis Pharma's lipid vector technology (LVT), and can enter cells in the absence of hENT1. Therefore, CP-4126 may overcome hENT1-mediated resistance to gemcitabine. CP-4126 is currently being evaluated as a single agent in a pivotal randomized trial (LEAP) in 360 patients with metastatic pancreatic cancer. Top-line data from this study are expected in Q4 2012.

The objectives of this new study in NSCLC are to:

    --determine the maximum tolerated dose of CP-4126 when combined with a fixed dose of cisplatin in patients with solid tumours
    --select a recommended dose for dose expansion in patients with advanced (Stage IIIb/IV) NSCLC
    --explore clinical activity of CP-4126 in patients with Stage IIIb/IV NSCLC

Olav Hellebo, CEO of Clavis Pharma, said:

"We believe that CP-4126 may provide a new option for treating cancer patients for whom gemcitabine proves ineffective, in particular those patients whose tumours are found to have low hENT1 expression. NSCLC is an area of high unmet medical need. Gemcitabine offers limited benefits and hENT is a potential biomarker for lung cancer patients selection. This makes it an exciting possible new indication for CP-4126 to follow our lead indication in pancreatic cancer."

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Contacts:
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
[email protected]

Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
[email protected]

Mark Swallow / Nina Enegren / David Dible (International Media Enquiries)
Citigate Dewe Rogerson
+44 207 282 2948
[email protected]

Peter Rahmer (US Investor enquiries)
The Trout Group
+1 646 378 2973 Direct / + 646 272 8526 Cell
[email protected]

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About Non-Small-Cell Lung Cancer (NSCLC)

Lung cancer is one of the most commonly diagnosed cancers worldwide and is the leading cause of cancer-related deaths around the globe. According to the American Cancer Society, NSCLC accounts for approximately 85% of all newly diagnosed lung cancer.

There are three common forms of NSCLC: Adenocarcinomas (often found in an outer area of the lung); Squamous cell carcinomas (usually found in the center of the lung next to an air tube (bronchus)); and Large cell carcinomas (can occur in any part of the lung).

In the US, deaths due to lung cancer are expected to account for 28% of all cancer deaths in 2012, more than from colon, breast and prostate cancers combined. It is estimated that there will be over 226,000 new cases of lung cancer in the US in 2012 and over 160,000 deaths due to this disease. Recent statistics estimate that over 287,000 people in the European Union (EU) were diagnosed with lung cancer in 2008, and approximately 252,000 people in the EU died from this disease.

Lung cancer is generally caused by smoking or exposure to pollution or tumorigenic chemicals. The symptoms of lung cancer usually do not appear until the disease is already at an advanced stage and incurable. Lung cancer remains one of the cancer types with the worst prognosis. The one-year relative survival for lung cancer is less than 50% and the five-year survival rate is 16%; the five year survival rate for NSCLC is only 5%, underlining the unmet need in this disease.

References

    Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM.GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet] Lyon, France: International Agency for Research on Cancer, 2010. Available from: http://globocan.iarc.fr.
    American Cancer Society.: Cancer Facts and Figures 2012. Atlanta, Ga: American Cancer Society, 2012. Available online.

About Clavis Pharma

Clavis Pharma ASA is a clinical-stage oncology focused pharmaceutical 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 development:

    Elacytarabine, a leukaemia drug, currently in a randomized, controlled Phase III study in relapsed or refractory acute myeloid leukaemia;
    CP-4126, is currently in a pivotal clinical study compared to gemcitabine for the 1st line treatment of pancreatic cancer and a Phase II trial for 2nd line treatment for pancreatic cancer in patients refractory to 1st line gemcitabine treatment;
    CP-4200, an azacitidine derivative, in preclinical development for myelodysplastic syndrome (MDS), a disease that is 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. 

www.clavispharma.com

Forward-looking statements:

This release and any materials distributed in connection with this release may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the Company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.
 

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