Jul 03, 2009 (Hugin via COMTEX) -- Oslo, Norway, 3 July 2009 - Clavis Pharma ASA (OSE: CLAVIS) announces today that it has received clearance by the United States Food and Drug Administration (FDA) to include patients in the USA in its phase II clinical programme for Intravenous CP-4126. Intravenous CP-4126 is in development as a new, first-line treatment for pancreatic cancer and the phase II program has already been initiated in Europe. Clavis Pharma will now begin preparations at selected clinical sites for an expansion of the phase II programme into the USA.

Intravenous CP-4126 is based on Clavis Pharma's proprietary Lipid Vector Technology (LVT) and aimed at improving the therapeutic profile of the current standard treatment for advanced pancreatic cancer, gemcitabine (Gemzar(R)). Currently it is estimated that pancreatic tumours in up to two-thirds of patients have a deficient cellular uptake of gemcitabine due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the tumour cell membrane1. This is known to limit the efficacy of gemcitabine treatment in these patients. In contrast, cellular uptake of Intravenous CP-4126 is independent of hENT1, which offers a potential clinical advantage for the product in the treatment of pancreatic cancer. In the phase II programme, cancer tissue (biopsies) from each patient will be collected and analysed with regard to levels of hENT1. The relation between response to treatment and hENT1 levels will be studied.

"Our phase II programme for Intravenous CP-4126 follows the successful completion of a phase I study in solid tumour cancer patients. This earlier trial, in line with preclinical data, suggests that CP-4126 may be of clinical benefit for patients that do not respond to gemcitabine as well as those that currently benefit from gemcitabine," says Geir Christian Melen, CEO of Clavis Pharma. "The acceptance of the IND is an important milestone for us that acknowledge our data on file for Intravenous CP-4126 and may enable us to accelerate our phase II programme through expansion in the USA." 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 1 Ref: Giovannetti et al., Cancer Research 66, 3928-3935, April 1, 2006 About Intravenous CP-4126 CP-4126 is a novel Lipid Vector Technology analogue of gemcitabine (Gemzar(R)), one of the world's leading cancer drugs, 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.

About Pancreatic cancer Pancreatic cancer is a very serious disease and an indication with a high 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 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] 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).

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 is a registered trademark of Clavis Pharma ASA.

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.

SOURCE: Clavis Pharma ASA

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