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Clavis Pharma ASA Oslo, Norway, 29 July 2008 Clavis Pharma (OSE: CLAVIS) announced today that it is amending its clinical program for ELACYT following an evaluation of all clinical data available for ELACYT(TM), both in haematology and solid tumours.
"We are now focusing our clinical trials with ELACYT primarily on haematological cancers reflecting our recently gained in-depth knowledge of certain important cellular uptake mechanisms, whilst we continue to evaluate the clinical activity of an intense dosing regimen in ovarian cancer ", says Geir Christian Melen, CEO of Clavis Pharma. "Furthermore, the recent orphan drug designation of ELACYT in the USA in addition to the EU designation, support our clinical trial program in haematology focusing on the large unmet medical need for Acute Myeloid Leukemia patients".
ELACYT is currently being tested in several clinical studies; Phase II in Acute Myeloid Leukemia (AML), Phase I in haematology in combination with idarubicin (Idamycin), Phase II in colorectal cancer, Phase II in malignant melanoma in combination with sorafenib (Nexavar) and Phase II in ovarian cancer. In these studies, ELACYT is administered using various dosing regimens.
An evaluation has been completed in light of, amongst other factors, recently published data showing that the uptake of ELACYT is independent of a certain cellular uptake mechanism (a specific nucleoside transporter) whereas the parent drug cytarabine is dependent of this transporter for entry into the cell. Patients have various expression levels of this specific uptake mechanism and the level is known to play an important role in the outcome of treatment of AML with cytarabine.
Based on an evaluation of available data, and taking into consideration the more intense dosing regimen applied in the recently launched trial in ovarian cancer, Clavis Pharma has made a decision to suspend further enrolment of patients under the current dosing regimen in the colorectal cancer and the malignant melanoma studies. These two studies have been designed to evaluate the efficacy and safety of ELACYT in patients with advanced disease, in colorectal cancer after failure of previous chemotherapy, and in melanoma both in newly diagnosed and previously treated patients. ELACYT was administered as a 30-minute infusion days 1-5 of a 28-day treatment cycle. While ELACYT in these trials has demonstrated a satisfactory safety profile, the drug has shown modest clinical activity with a limited number of patients experiencing stabilisation of the disease. In the ovarian cancer study, ELACYT is being administered as a 2 hour infusion days 1-5 and days 8-12 of a 28-day treatment cycle. Pending results from the more intense dosing regimen in the ovarian cancer trial, Clavis Pharma will amend the ELACYT clinical trial program in solid tumours, including colorectal cancer and malignant melanoma. For ELACYT, Clavis Pharma will now primarily focus on completing the ongoing trials in haematology and initiating another Phase II trial in AML upon completion of the ongoing Phase I trial in combination with idarubicin. The second Phase II trial in AML will evaluate ELACYT in 1st salvage patients (corresponding to 2nd line patients), whilst the ongoing Phase II trial is evaluating ELACYT in 2nd salvage patients (corresponding to 3rd line patients).
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. 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 ELACYT and haematological cancers (cancers of the blood) ELACYT is a novel cytotoxic agent, an analogue of cytarabine, a backbone of therapy in acute leukaemia. In a Phase I part of a Phase I/II study patients with haematological malignancies were treated with ELACYT as a single agent. As previously reported, patients with haematological malignancies tolerated treatment with ELACYT well both when administered as a short-lasting infusion and as continuous infusion. Clinical activity was observed with minimal non-hematologic toxicity. The phase II part of the study is now ongoing. This phase II study is evaluating the efficacy and safety of ELACYT in patients with late stage acute myeloid leukaemia (AML). This is a patient group with limited treatment options and short expected survival. Based on recommendations from an international clinical expert group, patients are dosed with ELACYT 2000 mg/m2/day administered by continuous infusion. ELACYT has received orphan drug designation both in the US and Europe for the treatment of AML. Approximately 300,000 new cases of leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia represents a market with high unmet medical needs, which may open for accelerated approval processes to expedite market access for new drugs. It is a segmented market covering a broad variety of disorders. A major clinical concern is the high rate of disease recurrence. The five-year survival for the most common acute leukaemia type, acute myeloid leukaemia (AML), is in the range of 5-10% for treated elderly patients, and approximately 30% for treated younger adults.
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.
