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Clavis Pharma ASA. (8/25/11). "Press Release: Clavis Pharma Expands Phase III CLAVELA Study in Patients with Acute Myeloid Leukemia (AML)". Oslo.
|Organisation||Clavis Pharma ASA|
|Organisation 2||Citigate Dewe Rogerson|
|Product 2||Lipid Vector Technology (LVT)|
|Person||Hellebø, Olav (Clavis Pharma 201108 CEO)|
|Person 2||Manum, Gunnar (Clavis Pharma 201107 CFO)|
Clavis Pharma ASA (OSE: CLAVIS); the Norwegian cancer drug development company, announces today that is has decided to expand its pivotal Phase III CLAVELA study, investigating elacytarabine in patients with late-stage acute myeloid leukaemia (AML), in order to maximise the chances of success, the statistical power of the study has been increased from 80% to close to 90%. The inclusion criteria have also been amended, and patients over the age of 65 with disease of poor prognosis are now eligible for study entry after only one previous treatment cycle, significantly expanding the potential first launch patient population. The primary endpoint of survival will now be evaluated after 300 events have occurred vs. 250 events previously, and the study is expected to enrol approximately 400 patients. Top line data are now expected to be available in Q4 2012.
The CLAVELA study is a Phase III open-label randomised, controlled trial comparing elacytarabine with the investigator's choice of treatment in patients with late-stage AML. The objective is to demonstrate superiority of elacytarabine over current therapies. Patients will be randomised to each arm of the study and the difference in overall survival and other parameters will be measured.
Olav Hellebø, Clavis Pharma CEO, commented: "Clavis Pharma is in a rare position for a company of our size in having two drug candidates in pivotal trials, with both expected to read out in 2012. We are committed to ensuring our trials are as robust as possible and designed to provide the clearest measure of efficacy. The next 12-18 months will be very exciting for us as we unveil results from the clinical development programmes for these novel compounds."
For further information contact:
Chief Executive Officer
+47 24 11 09 50
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
About Clavis Pharma
Clavis Pharma ASA is a late clinical stage oncology discovery and drug development company based in Oslo, Norway with a portfolio of novel anti-cancer drugs in development. These patented New Chemical Entities (NCEs) are novel, improved versions of commercially successful drugs, made using Clavis Pharma's Lipid Vector Technology (LVT) chemistry. Data generated suggests these potential breakthrough products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue penetration, altered metabolism and, in certain cases, additional modes of action.
Clavis Pharma's has several drug candidates in formal development studies:
> Elacytarabine, a leukaemia drug, currently in a randomized, controlled Phase III study in late-stage acute myeloid leukaemia;
> CP-4126, is currently in a pivotal clinical study compared to gemcitabine for the 1st line treatment of pancreatic cancer and a Phase II trial for 2nd line treatment for pancreatic cancer in patients refractory to 1st line gemcitabine treatment;
> CP-4200, an azacitidine derivative, in preclinical development for myelodysplastic syndrome (MDS), a disease that is often a precursor to leukaemia.
Clavis Pharma intends to commercialise its products through strategic alliances and partnerships with experienced oncology businesses and, where and when commercially appropriate, by establishing its own sales and marketing capabilities. CP-4126 is licensed to Clovis Oncology globally. Clavis Pharma has an option to co-promote CP-4126 in Europe.
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. These 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 the information or projections contained herein. Clavis Pharma is a registered trademark of Clavis Pharma ASA.
Record changed: 2011-11-25
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