Oslo, Norway, October 27, 2011
Clavis Pharma ASA (OSE: CLAVIS); the Norwegian cancer drug development company, announces today its results for the third quarter (period ended September 30)
Highlights
- In August, the Company announced that it was expanding the pivotal Phase III CLAVELA study investigating elacytarabine in patients with late-stage acute myeloid leukaemia (AML). The expansion increases the statistical power of the study from 80% to close to 90%. The primary endpoint of survival will now be evaluated after 300 events (deaths) have occurred vs. 250 events previously planned. The inclusion criteria have also been amended, significantly expanding the potential patient population at launch. The study is progressing well and top line data from the CLAVELA study are expected in Q4 2012.
- The Company reported encouraging interim efficacy data in August from the Phase II clinical trial with elacytarabine in combination with idarubicin in patients with early stage AML who have failed cytarabine-containing first-course chemotherapy. The interim results showed a complete remission (CR/CRi) rate of 48%, independent of the patients’ hENT1 status. In addition, a correlation between hENT1 status and clinical responses to first-line cytarabine-containing therapy was seen, supporting the potential of hENT1 measurement as a means of identifying AML patients who are most likely to significantly benefit from elacytarabine-containing therapy. An abstract describing these interim results has been submitted for presentation at the upcoming American Society of Haematology meeting in San Diego, CA, USA (10-13 December 2011).
- In conjunction with the expansion of the CLAVELA study, the Company decided to delay the start of the clinical Phase I of CP-4200 in order to focus resources on CLAVELA.
- Nicholas Adams joined Clavis Pharma as Chief Business Officer in July, bringing more than 23 years of experience in the healthcare industry, including 12 years as VP Business Development at UK-based Antisoma plc.
- Research and development costs and other operating expenses amounted to NOK 56 million for the third quarter and NOK 148 million for the first nine months of 2011.
- The Company had cash and cash equivalents of NOK 251 million at 30 September 2011.
Post-period Events
- The retrospective study of hENT1 expression in patients with pancreatic cancer (study 002) was completed in October, establishing the cut-off level for defining hENT1 low vs. high expression. This cut-off level will be used to assess the results from the on-going pivotal LEAP clinical trial with CP-4126 in patients with pancreatic cancer. Approximately two thirds of tissue samples tested were measured as low hENT1 based on this newly established cut-off and the hENT1 cut-off level determined from the 002 study shows a highly statistically significant and clinically meaningful difference in overall survival between low and high hENT1 expression in gemcitabine-treated patients.
Olav Hellebø, Clavis Pharma CEO, commented: "In recent months we have made significant progress with our two key late stage drug development programs, elacytarabine and CP-4126. With the expansion of our pivotal Phase III CLAVELA trial we believe we are well placed to demonstrate the clinical benefits of elacytarabine. Our confidence in elacytarbine has been reinforced by the excellent interim efficacy data that we have reported from the Phase II idarubicin combination study. The completion of the observational study 002 is an important milestone in the development of CP-4126 as it has shown that there is a clear correlation between hENT1 levels and survival in patients with pancreatic cancer treated with gemcitabine. The study has also allowed us to establish the ‘cut-off’ level for low hENT1 that will be used in the on-going pivotal LEAP clinical trial in patients with pancreatic cancer. I am looking forward to delivering the pivotal data for both elacytarabine and CP-4126 towards the end of 2012.”
The Third Quarter Report and Presentation are available on www.clavispharma.com
For further information contact:
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
olav.hellebo@clavispharma.com
Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum@clavispharma.com
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma@citigatedr.co.uk
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.
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. 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.