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Oslo, Norway, 6 February 2007
Clavis Pharma (OSE: CLAVIS) announced today that it will expand the clinical program for its lead product, ELACYTTM, as a potential treatment in metastatic colorectal cancer. The company has received approval from UK Health Authorities to
initiate a Phase II clinical trial at Beatson Oncology Centre, University of Glasgow, with Professor Jim Cassidy as principal investigator. Beatson Oncology Centre is a well recognized cancer centre with particular
interest and expertise in colorectal cancer and Professor Cassidy is an international key opinion leader in this field.
"We are very excited about expanding our clinical program for ELACYTTM into treatment of colorectal cancer. Relapsed colorectal cancer is a truly devastating disease, where the survival rate averages
a dismal 10% for patients with distant metastases. Our initial preclinical and exploratory clinical results give us reason
to believe that ELACYTTM will be beneficial in treatment of patients with colorectal cancer", stated Tom E. Pike, Chief Executive Officer of Clavis
Pharma.
Patient enrolment in the present trial is expected to commence in the near future, following the final go-ahead from the Beatson
Oncology Centre's ethics committee. Initially ELACYTTM will be given in a mono-therapy setting. Combinations of ELACYTTM with other anti-cancer agents are future options to be considered when more data become available. The trial is designed
to show activity of ELACYTTM in patients who have relapsed after first line treatment.
"This clinical trial represents one of several exploratory studies Clavis Pharma will initiate to demonstrate the potential
of ELACYTTM in the treatment of solid tumours as well as haematological malignancies (blood cancers). Approval by Health Authorities
to initiate phase II in relapsed colorectal cancer is a significant milestone in a new development program, opening one of
the larger segments of the cancer marked, and hence expanding Clavis Pharma's commercial potential", said Tom E. Pike.
The Investigator of the study Professor Jim Cassidy, commented, "Despite continuous efforts over the last decade to offer
patients with advanced colorectal cancer new therapies, current results are highly unsatisfactory with five year survival
rates in the 10% range. ELACYTTM is a promising agent and we are delighted to be able to participate in the clinical development program."
Contact:
Tom Pike
Chief Executive Officer
Tel: + 47 915 19 652 / + 47 24 11 09 50
tom.pike@clavispharma.com
www.clavispharma.com
About Clavis Pharma
Clavis Pharma ASA
is a public oncology focused pharmaceutical company leveraging its proprietary Lipid Vector Technology (LVT) platform to
create New Chemical Entities (NCEs) by significantly improving approved drugs. The improvement is 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 intends 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 strategic
partnerships with established pharmaceutical or biotech companies. The company's product portfolio includes three new cancer
drugs, of which the first
ELACYTTM
, is in clinical phase II, the second, CP-4126, is in clinical phase I, and the third is in the pre-clinical phase. Results
indicate that ELACYTTM has a promising potential for several cancer indications within solid tumours and leukaemia.
Clavis Pharma ASA is listed on the Oslo Stock Exchange (ticker: CLAVIS). Additional information on Clavis Pharma can be found at:
www.clavispharma.com
About Colorectal Cancer
Colorectal cancer - cancer of the colon or rectum - is the second leading cause of cancer-related deaths (behind lung cancer)
in the United States for both men and women combined and a WHO report indicate that 655 000 people worldwide died from colorectal
cancers in 2005 and 145 000 new cases of colorectal cancers was detected last year in US alone. Patients who detect their
colorectal cancer at an early stage have good prognosis, with a five-year survival of approximately 90%. However, patients
with a grade 4 colorectal cancer (spread to lymph nodes and distant metastasis), has a mean five-year survival rate of less
than 10%. Consequently, there is a significant opportunity for development of new agents to impact the treatment of this disease.
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 PharmaTM and ELACYTTM are registered trademarks of Clavis Pharma ASA.
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