Clavis Pharma Announces Expansion Of ELACYT(TM) Clinical Development Program

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology
Article Date: 14 Mar 2008 - 3:00 PDT

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Clavis Pharma (OSE: CLAVIS) announced that it has received approval from the Belgian Authorities to initiate a new Phase II clinical study with ELACYT(TM) 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."

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 ELACYT(TM), 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.

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(TM) and ELACYT(TM) are registered trademarks of Clavis Pharma ASA.

Clavis Pharma ASA