Clavis Pharma Starts ELACYT(TM) Phase II Study In Haematology

Main Category: Lymphoma / Leukemia
Also Included In: Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 03 Apr 2008 - 15:00 PDT

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Clavis Pharma (OSE: CLAVIS) announced that it has started recruiting patients to the phase II part of its clinical phase I/II study with ELACYT(TM), 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".

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 here.

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

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.

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