Clavis Pharma Announces Recruitment of the First Patients in Phase II Study comparing CP-4126 with gemcitabine in pancreatic cancer
Trial will evaluate impact of patient hENT1 levels on survival outcomes
Oslo, Norway,Â 6 August 2010
Clavis Pharma (OSE: CLAVIS), the Norwegian cancer drug development company, and
its partner Clovis Oncology, Inc. announce that the first two patients have been
recruited into a Phase II clinical study comparing CP-4126 (also known as
CO-1.01) with gemcitabine in the treatment of patients with pancreatic cancer.
The trial is being conducted by Clovis Oncology as part of the $380 million
partnership agreement signed with Clavis Pharma in November 2009. Under the
terms of that agreement, Clovis is responsible for development and
commercialization of CP-4126 in the US, EU and certain rest of world countries.
CP-4126 is a novel, patented, lipid-conjugated derivative of the anti-cancer
drug gemcitabine, developed using Clavis' lipid vector technology (LVT). It is
designed to improve upon the efficacy of gemcitabine by enabling the drug to
enter cancer cells without requiring membrane expression of transporter
proteins.Â The entry of gemcitabine into tumour cells is dependent upon the
expression of specific membrane transporter proteins, particularly hENT1.
Gemcitabine is the current standard treatment for advanced pancreatic cancer,
and is also used in combination with other chemotherapy agents for the treatment
of other cancers, including ovarian, non-small cell lung and breast
cancer.Â CP-4126 has been granted orphan drug status for the treatment of
pancreatic cancer in the US and EU.
The Phase II trial is an international, randomised, controlled study in patients
newly diagnosed with advanced, metastatic (stage 4) pancreatic cancer. The trial
will enrol approximately 250 patients, across 80 centers around the world,
randomised equally between the CP-4126 and gemcitabine arms. Eligible patients
will have received no prior chemotherapy for advanced disease and must have
metastasis biopsies available for analysis. This is the first randomized trial
in pancreatic cancer to require tumour biopsies as an entry criterion, and will
allow clinical outcomes to be correlated with specific molecular features of
each patient's tumour.
The study will measure overall survival (OS) in prospectively-defined hENT1-low
patients as the primary endpoint. Expression of hENT1 in metastatic tumour
tissue will be measured during the trial and patients categorised into
hENT1-high or hENT1-low groups prior to final analysis. The study is designed to
show a statistically significant improvement in survival in patients with hENT1
low expression in CP-4126 compared to patients on gemcitabine.
The secondary endpoints of the study include:
* Overall survival in all patients and hENT1 high patients
* Tumour response, progression free survival and response duration
* Changes in CA 19-9, a tumour marker for pancreatic cancer
* Safety and toxicity and Quality of Life
Clovis Oncology anticipates that recruitment of this Phase II study will
complete in 2011 and that it will report results from the trial in 2012.
In parallel, Clovis Oncology has entered into an agreement with Ventana Medical
Systems, Inc. for the development of a companion diagnostic test to measure
hENT1-levels in pancreatic tumours and classify hENT1 low patients.
Olav HellebÃ¸, CEO of Clavis Pharma, said: "We have developed a very good working
relationship with Clovis Oncology over the past six months and we have been
impressed by the resources they have put behind this important study to evaluate
CP-4126. We believe that new cancer therapies based on our LVT technology, such
as CP-4126 and also elacytarabine, will deliver their improved efficacy by being
able to reach their intended target independent of the hENT1 levels. We look
forward to reporting the results from this very important study in 2012."
For further information:
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 clinical stage oncology 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, an improved form of Ara-C, a leukaemia drug - about to
commence a Phase III randomized, controlled registration study in late-stage
acute myeloid leukaemia;
* Intravenous CP-4126, an improved version of gemcitabine - currently in a
Phase II comparative study with gemcitabine for the treatment of pancreatic
* CP-4200, an azacitidine derivative - in preclinical development for
myelodysplastic syndrome (MDS), 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 in the Americas and Europe.
Clavis Pharma has retained rights in other territories and an option to
co-promote CP-4126 in Europe.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker:
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
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