Clavis Pharma starts ELACYT™ phase II study in haematology
Oslo, Norway, April 3, 2008
Clavis Pharma (OSE: CLAVIS) announced today that it has started recruiting patients to the phase II
part of its clinical phase I/II study with ELACYT™, within haematological cancers. The phase II part
commences after the successful completion of phase I, which demonstrated a good safety profile, as
well as clinical activity. The phase II part will evaluate 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. Patients will be recruited at 16 major cancer centres in the USA and
Europe.
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 77 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 when administered as a short-lasting infusion and as continuous
infusion. An international clinical expert group made the recommendation on dose and schedule based
on phase I data and the study will continue with ELACYT 2000 mg/m2/day administered by
continuous infusion. ELACYT was granted orphan drug designation by the European Commission in
September 2007 for the treatment of AML.
The centres recruiting in the phase I part of the study were MD Anderson Cancer Centre (MDACC),
Houston, Duke University Hospital, Durham, and University of Texas Health Science Centre
(UTHSC), San Antonio, all in the USA and Institute Paoli Calmettes, Marseille, France. All four
centres will continue into the phase II part. Over the next weeks additional cancer centres will be
opened for recruitment in New York and Cleveland (USA); Oslo (Norway); Paris, Toulouse and Lyon
(France); Bologna and Rome (Italy); Berlin, Frankfurt and Münster (Germany); and Manchester (UK).
“At MDACC we are dedicated to quality patient care, innovative research, and developing more
effective treatments for all types of leukaemia” says Prof. Hagop Kantarjian, Chairman of the
Department of Leukaemia. "There is a strong biological rationale for evaluating ELACYT in
leukaemia and the drug has shown real promise against the disease in phase I. We are very pleased to
study ELACYT further in our refractory and relapsed AML patients."
“This phase I/II study in haematological cancers has shown excellent recruitment from day one.” says
Geir Christian Melen, CEO of Clavis Pharma. “We are looking forward to continue the study in phase
II together with an excellent and enthusiastic investigator team. Furthermore, we are pleased that we
are now pursuing 4 individual indications in phase II as part of our clinical development program for
Elacyt”.
Contact:
Geir Christian Melen
Chief Executive Officer
Tel: + 47 913 02 965/ + 47 24 11 09 50
geir.christian.melen@clavispharma.com
Bo I. Nilsson , MD, PhD.
Chief Medical Officer
Tel +47 932 92 006/ +47 24 11 09 50
bo.nilsson@clavispharma.com
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™, 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.
About Orphan Drugs
The European Commission grants orphan drug designation to promising products that address life-threatening medical conditions
affecting fewer than 230,000 persons in the European Union (EU). The designation allows for the use of the quickest way of placing
the medicinal product on the market throughout the EU (known as the “centralised procedure”), regulatory assistance related to the
development process and reduced regulatory fees throughout the product's life. If a product receives marketing approval, the
designation will entitle the company to exclusive marketing rights for 10 years following the approval. Orphan Drug Designation
provides companies with financial and regulatory incentives to pursue less common diseases. It should be noted that orphan drug
designation does not limit a drug to less common diseases. The drug may, in parallel or afterwards, also be developed for other
diseases.
Disclaimer
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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.
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Clavis Pharma™ and ELACYT™ are registered trademarks of Clavis Pharma ASA.