Oslo, 13 March 2008.
Clavis Pharma (OSE: CLAVIS) announced today that it has received approval from the Belgian Authorities to initiate a new Phase II clinical study with ELACYTTM in ovarian cancer at the University Hospital of Leuven, with Professor Ignace Vergote as principal investigator. The study has also been approved by the Independent Review Board (IRB) at the Cancer Therapy and Research Center, San Antonio, USA, with Professor Tyler Curiel as principal investigator. Both investigators are international opinion leaders in this field and the hospitals are well recognized cancer centres.
"We are excited about expanding our clinical program for ELACYT into the treatment of ovarian cancer. Ovarian cancer is the fifth leading cause of death in women and unfortunately it is often diagnosed too late for current curative surgery. In general, a number of therapeutic approaches are therefore needed for an effective management of the disease. We hope ELACYT will be an additional option in treatment of this malignancy in the future" says Bo Nilsson, Chief Medical Officer of Clavis Pharma.
The study is designed to show activity of ELACYT in women who have relapsed after prior chemotherapy regimens. The patient enrolment is expected to commence in the near future. ELACYT will be given in a new and prolonged schedule compared to the treatment of solid tumours in previous studies. The patient will be treated for10 days (5 + 5 days) followed by a 2 weeks drug-free period. Clavis believes, based upon preclinical and clinical observations, that such repeated daily treatment will be more efficacious in this study population. Ovarian cancer is the fourth type of cancer that ELACYT is being developed for. Already ongoing programmes include malignant melanoma, colorectal cancer and leukaemia. "An approval to initiate a phase II study in relapsed ovarian cancer is a significant milestone in our development program, opening a larger segment of the cancer marked, and hence expanding Clavis Pharma's commercial potential", declares Tom E. Pike, CEO of Clavis Pharma. The study is a multicentre study and other study centres will be included in the near future.
The investigator in Leuven, Professor Ignace Vergote, commented, "Despite continuous efforts over the last decade to offer women with advanced ovarian cancer new therapies, current results are highly unsatisfactory with a 5 years survival up to 30%. . ELACYT 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
Bo Nilsson
Chief Medical Officer
Tel: + 47 932 92 006 / + 47 24 11 09 50
bo.nilsson@clavispharma.com
www.clavispharma.com
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 other 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, CP-4200, is in 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). Additional information on Clavis Pharma can be found at: http://www.clavispharma.com/ .
About Ovarian Cancer
The American Cancer Society estimated that there would be 22,400 new cases of ovarian cancer in 2007 in the US. Estimates
indicate that 1 in 70 women will develop ovarian cancer in her lifetime. While 93% of women diagnosed with early stage ovarian
cancer will survive 5 years or more, and most of them will be cured, only 19% of ovarian cancers are found at that early stage.
As a result, ovarian cancer ranks fifth in cancer deaths among women, with an estimate of 15,300 deaths in the US during 2007.
Historically, ovarian cancer has been called the "silent killer" because symptoms often became apparent so late in the process
that chances of a cure were poor.