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Oslo, Norway, 17 April 2007
Clavis Pharma announced today that the company presented the first preliminary data from its clinical Phase I/II study with
ELACYT in hematologic cancers during a poster session at the Annual Meeting of the American Association for Cancer Research
(AACR) in Los Angeles 16 April.
ELACYT is a novel cytotoxic agent in development for the treatment of hematologic cancers as well as for solid tumours. In
this ongoing Phase I/II study Clavis Pharma reports that patients with hematologic malignancies have tolerated ELACYT well
at doses up to 875 mg/m²/day (2 hour intravenous infusion) and 675 mg/m²/day (continuous intravenous infusion).
The primary objective of the initial dose finding part of the Phase I/II study is to determine the maximum tolerated dose
of ELACYT given as a single agent in patients with resistant hematologic malignancies. Secondary objectives are characterization
of the safety profile of ELACYT in these patients and determination of the preferred regimen of the drug to be administered
in subsequent studies. The second part of the study will evaluate the effect of ELACYT at the optimal dose and regimen. No
dose limiting toxicity has yet been observed, hence the maximum tolerated dose has not yet been established. The dose escalation
in Phase I is ongoing. Although the optimal dose level has not yet been determined, significant clinical benefit has been
reported in some patients.
"ELACYT is an analogue of cytarabine (ara-C), which has been a cornerstone in the treatment of leukaemia for 30 years. ELACYT
is designed to provide further benefits to the patients, and the results presented at AACR are encouraging," says Tom Pike,
CEO of Clavis Pharma. "We are looking forward to establishing the recommended dose and commence with the Phase II efficacy
part of the study. We are happy to observe that there is high interest from distinguished hematologic centres on both sides
of the Atlantic to take part in this study"
The Co-ordinating Investigator of the study, Professor Frank Giles, Chief, Division of Hematology and Medical Oncology, University
of Texas Health Science Center at San Antonio commented, "Patients with acute leukaemia need better agents as current results
are highly unsatisfactory. ELACYT bears the promise of providing significant improvements over existing therapy and I am delighted
to see that the study already has excellent recruitment in both continents and that the preliminary data fully supports further
investigations".
This initial phase of the multicentre Phase I/II study is ongoing at MD Anderson Cancer Centre, Houston, Texas, USA, Institute
Paoli Calmettes, Marseille France and Duke University Hospital, USA. A number of new sites are being recruited for the Phase
II - efficacy, part of the study.
Contact:
Tom Pike
Chief Executive Officer
Tel: + 47 915 19 652 / + 47 24 11 09 50
tom.pike@clavispharma.com
www.clavispharma.com
About Clavis Pharma
Clavis Pharma ASA is a public oncology focused pharmaceutical company leveraging its proprietary Lipid Vector Technology (LVT) platform to
create New Chemical Entities (NCEs) by significantly improving approved drugs. The improvement is 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 intends 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 strategic
partnerships with established pharmaceutical or 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 is in the pre-clinical phase. Results
indicate that ELACYT has a promising potential for several cancer indications within solid tumours and leukaemia.
Clavis Pharma ASA is listed on the Oslo Stock Exchange (ticker: CLAVIS). 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
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 PharmaTM and ELACYTTM are registered trademarks of Clavis Pharma ASA.
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