1 June 2006
Norwegian-based biopharmaceutical company Clavis Pharma ASA today announced the first patient has received treatment in a multicentre Phase I/II study in leukaemia with its lead compound, ELACYTTM. The patient was treated at the US hospital, MD Anderson Cancer Centre, Houston, Texas. Two more sites, one in the US and one in Europe is preparing for patient enrolment later this summer.
The primary objective of the initial part of the Phase I/II study is to determine the maximum tolerated dose of ELACYTTM given as a single agent in patients with refractory/relapsed haematologic malignancies. Secondary objectives are characterization of the safety profile of ELACYTTM in these patients and determination of the preferred regimen of ELACYTTM to be administered in subsequent pivotal studies. The Second part of the study will evaluate the effect of ELACYTTM at the optimal dose.
"Initiation of the clinical study in leukaemia patients is an exciting step forward in the development of ELACYTTM. ELACYTTM is an analogue of cytarabine (ara-C), which has been a cornerstone in the treatment of leukaemia. ELACYTTM is designed to provide further benefits to the patients, and we aim to document this in the new study," says Tom Pike, CEO of Clavis Pharma. "The company decided to pursue this program based upon preclinical data and results from Phase I in solid tumour patients as well as high interest for the drug from opinion leaders within leukaemia treatment. To date ELACYTTM has been successfully studied in solid tumour patients and is currently being evaluated as treatment for previously untreated malignant melanoma in a multicentre Phase II study."
The Coordinating Investigator of the study Dr. Frank Giles, MD, Professor, Department of Leukaemia, MD Anderson Cancer Centre, Houston, TX commented, "Patients with acute leukaemia need better agents as current results are highly unsatisfactory. Improvements in the design of nucleoside analogs have lead to better results and a sequence of regulatory approvals. ELACYTTM is a very exciting drug for patients with leukaemia. It offers us a significant opportunity to improve on the results we currently obtain with its parent ara-C, the latter being the single most effective agent discovered to date for patients with acute myeloid leukaemia. We are delighted that the ELACYTTM clinical program in leukaemia is underway and look forward to rapidly obtaining initial data"
Contact:
Tom Pike
Chief Executive Officer,
Tel: +47 9151 9652
About Clavis Pharma
Clavis PharmaTM was founded in 2001 by Norsk Hydro and NeoMed. The company develops new and superior pharmaceuticals based on its proprietary Lipid Vector Technology (LVT). LVT involves the synthesis of specific fatty acid analogues of pharmaceutical agents, thereby creating new chemical entities with improved biological properties. LVT has the potential to improve drug performance and dosing characteristics and to reduce the side effects of drug treatment for serious illnesses, such as cancer and infectious diseases. The technology is based on more than a decade of research conducted by Norsk Hydro, a major Norwegian industrial group. The intellectual property currently consists of more than 150 internationally granted patents within 5 patent families.
The company's product portfolio includes three new cancer drugs, the first of which, ELACYTTM , is in clinical phase II, the second is about to enter clinical phase I, and the third is in the pre-clinical phase. Research results so far indicate that ELACYTTM has a promising potential for several cancer indications within solid tumours and leukaemia.
Clavis Pharma's largest investors are: MVM Fund, NeoMed Innovation III, Norsk Hydro, Braganza AS and Høegh Capital Partners.
Additional information on Clavis Pharma can be found at: www.clavispharma.com
About Leukaemia
Approximately 300,000 new cases in leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia represents a market with high unmet medical needs. The high unmet medical need may open for accelerated approval pathways 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 reoccurrence. 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 (the majority receive no specific anti-AML therapy) and is about 30% in treated younger adults.
Disclaimer
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.
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