Clavis Pharma ASA receives USD 1.1 million Grant from Innovation Norway to Accelerate the Phase II Programme of Intravenous CP-4126 in Pancreatic Cancer
Oslo, Norway, 27 August 2009
Clavis Pharma ASA (OSE: CLAVIS) announced today that it has received a government grant of up to USD 1.1 mill (NOK 6.9 mill) to accelerate the Phase II clinical programme with Intravenous CP-4126 in patients with newly diagnosed, advanced pancreatic cancer. The grant award was made by Innovation Norway.
CP-4126 is based on Clavis Pharma's proprietary Lipid Vector Technology (LVT) and is aimed at improving the therapeutic profile of the current standard treatment for advanced pancreatic cancer gemcitabine (Gemzar®).
Research suggests that the treatment of pancreatic cancer and a number of other cancers could be improved by increasing the amount of anti-cancer agent that enters the tumour cells. In the case of pancreatic tumours published research demonstrates that up to two-thirds of patients respond poorly to gemcitabine due to deficient expression of a transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the cell membrane1 and sub-optimal cellular uptake of gemcitabine. The transport protein is necessary for the uptake of gemcitabine into the tumour cell and therefore it is believed that the lack of hENT1 limits the efficacy of the treatment for patients with deficient protein levels. Intravenous CP-4126 has been designed to overcome this problem as its cellular uptake is independent of hENT1 levels on the surface of the tumour cell. This means that Intravenous CP-4126 could be an attractive treatment option in pancreatic patients with a deficient hENT1 transport system.
In the phase II programme, cancer tissue (biopsies) from each patient will be collected and analysed in order to determine their levels of hENT1. The relationship between response to treatment and hENT1 levels will be an important output from this phase II study as this relationship could allow clinicians to predict which patients are unlikely to respond to gemcitiabine prior to therapy - patients who potentially would benefit from Intravenous CP-4126.
The USD 1.1 million grant is provided by Innovation Norway through its public R&D programme (Norwegian: Offentlig Forsknings- og Utviklingskontrakt, OFU) wherein an enterprise develops a novel product in collaboration with a University Hospital. In this case the contract partner for Clavis Pharma is the Oslo University Hospital with Dr. Tone Ikdahl acting as Coordinating Investigator. The grant is payable to Clavis Pharma based on project accounts in 2009 and 2010.
Wilhelm R. Wold, Senior Advisor at Innovation Norway, says "We are happy that Innovation Norway through the OFU programme can be a key contributor to the development of Intravenous CP-4126 by supporting this collaborative project that Clavis Pharma and Oslo University Hospital have set up to provide proof-of-principle for this new therapy in the treatment of pancreatic cancer. Clavis Pharma is one of the promising biotech companies in Norway and it is important for Innovation Norway to contribute to this growing industry".
"This government grant will support the clinical Phase II programme we have recently started with Intravenous CP-4126 in pancreatic cancer and provide further validation of the potential of our Lipid Vector Technology to generate new products with real benefits to cancer patients around the world," says Geir Christian Melen, CEO of Clavis Pharma. "The support by Innovation Norway and Oslo University Hospital is an acknowledgment of the exciting novel approach we have taken with Intravenous CP-4126, a drug which has the potential to become a new first-line treatment for patients with pancreatic cancer."
1 Ref: Giovannetti et al., Cancer Research 66, 3928-3935, April 1, 2006
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
For international press enquiries:
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
Office : +44 207 282 2948
E-mail : clavispharma@citigatedr.co.uk
About Intravenous CP-4126
CP-4126 is a novel Lipid Vector Technology analogue of gemcitabine (Gemzar®), one of the world's leading cancer drugs. It
is used in the treatment of several cancers, such as pancreatic cancer, ovarian cancer and non-small cell lung cancer. Gemzar
is a blockbuster cancer drug, with 2008 sales of USD 1.7 billion. Clavis Pharma is developing Intravenous CP-4126, which has
a different therapeutic profile and may potentially have effect in patients who are resistant or refractory to gemcitabine
treatment. An Investigational New Drug application (IND) for CP-4126 was approved by the US Food and Drug Administration in
July 2009.
About Pancreatic cancer
Pancreatic cancer is a very serious disease and an indication with an unmet medical need. Approximately 37,000 new cases of
pancreatic cancer were recorded in the USA in 2007. The 1-year and 5-year overall survival rates are estimated at 23% and
4%, respectively. The majority of these patients have unresectable disease or will recur after surgery. Median overall survival
in these patients is approximately 8-12 months. The standard first-line therapy for patients with unresectable disease is
gemcitabine monotherapy. Unfortunately, many of these patients fail to benefit from treatment.
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 well 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
and improved penetration into cells.
The Company's business strategy is to develop innovative oncology drug candidates until safety and efficacy has been demonstrated in humans and to establish partnerships with pharmaceutical or biotech companies for further development and commercialisation. The company may consider retaining marketing or co-marketing rights in certain territories and may develop its own sales and marketing capacity in these regions.
The company's product portfolio includes four new cancer drugs: Elacytarabine and Intravenous CP-4126 are 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).
About Innovation Norway
Innovation Norway is a governmental body to promote nationwide industrial development profitable to both the business economy
and Norway's national economy, and contributes towards innovation, internationalisation and promotion. Innovation Norway is
a backer and promoter of entrepreneurs, and small and medium-sized enterprises that seek to grow in an international market,
by providing financing, linking customer enterprises to know-how and helping them build networks for their innovation projects.
Innovation Norway's slogan is "We give local ideas global opportunities".
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