Clavis Pharma Successfully Completes Clinical Phase I Study in Haematology
OSLO, Norway, February 11, 2008 - Clavis Pharma (OSE: CLAVIS) announced today that an important milestone has been reached in its haematology program with Elacyt(TM). The phase I part of the ongoing clinical phase I/II study within haematological cancers has been successfully completed. The maximal tolerated dose (MTD) has been determined and clinical activity has been reported. Defining the MTD is a prerequisite for embarking on the phase II part of the study. The Company is now in the process of confirming the dose and the optimal regimen to be used in the phase II part of the study where the efficacy of ELACYT will be evaluated. The phase II part is estimated to start when the dose and regimen has been decided by the international clinical expert group by the end of April 2008.
ELACYT is a novel cytotoxic agent, an analogue of cytarabine, a backbone of therapy in acute leukaemia. ELACYT is in development for the treatment of haematological cancers (blood cancers) as well as for solid tumours. In this ongoing phase I/II study 75 patients have been treated to date. Clavis Pharma reports that patients with haematological malignancies have tolerated ELACYT well at doses up to 2500 mg/m²/day both for 4 hour infusion and continuous infusion. The patient population in the phase II part are patients with late stage acute myeloid leukaemia (AML).
"ELACYT has shown a good safety profile for both regimens studied and the MTD was reached above the level where clinical activity was reported" says Tom Pike, CEO of Clavis Pharma. "We will soon open new sites for the phase II part and we are expecting the excellent recruitment to continue."
"We are pleasantly surprised that ELACYT has been better tolerated than anticipated when the study was initiated" says Bo Nilsson, CMO of Clavis Pharma. "The rapid patient enrolment is a sign of investigator enthusiasm, which is very encouraging for the company"
The centres involved in this study are MD Anderson Cancer Centre, Houston, Texas, USA, Institute Paoli Calmettes, Marseille, France, Duke University Hospital, USA and University of Texas Health Science Center (UTHSC), San Antonio, USA. The Co-ordinating Investigator of the study, Prof. Frank Giles, Chief, Division of Hematology and Medical Oncology, UTHSC, San Antonio is encouraged by the good progress and promising results of the study "ELACYT has demonstrated a satisfactory safety profile and potential therapeutic activity in leukaemia, a devastating disease with great needs for new treatment options.
Contact: Tom Pike Chief Executive Officer Tel: + 47 915 19 652 / + 47 24 11 09 50 firstname.lastname@example.org
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 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 Leukaemia 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.
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.
Posted: February 2008