Clavis Pharma's Co-Development Partner for CP-4126, Clovis Oncology, Inc. has signed an agreement to Develop and Commercialize hENT1 Companion Diagnostic with Ventana Medical Systems, Inc.
(Thomson Reuters ONE) -
Diagnostic test to identify cancer patients who may benefit from
Clavis Pharma's novel cancer drugs
Oslo, Norway, April 22, 2010
Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company,
is pleased to note that Clovis Oncology, it's partner in the development and
commercialisation of Clavis Pharma drug candidate CP-4126, and Ventana Medical
Systems, Inc. have entered into a collaboration agreement to develop a companion
diagnostic to CP-4126 (also known as CO-101) for clinical and commercial use.
Ventana Medical Systems is one of the world's leading developers and
manufactures of medical diagnostics.
The companion diagnostic is being developed to identify pancreatic cancer
patients with low-level tumour expression of the human equilibrative nucleoside
transporter 1 (hENT1) protein. Ultimately, the use of a hENT1 companion
diagnostic will enable oncologists to identify patients who may show a
significant benefit from treatment with Clavis Pharma's novel drug candidates.
The hENT1 transporter on tumour cells plays a crucial role in the uptake of
cytotoxic nucleoside-based drugs and their low level or absence have been
correlated to a poor clinical outcome to treatment with drugs such as
gemcitabine and cytarabine. It is estimated that pancreatic tumours in up to
two-thirds of patients have low levels of hENT1 on the tumour cell surface.
CP-4126, and other drug candidates in Clavis Pharma's portfolio, has been
developed using its proprietary Lipid Vector Technology (LVT), which enables the
compound to enter cancer cells independently of hENT1. CP-4126 is an LVT form of
gemcitabine, the current standard treatment for advanced pancreatic cancer, and
which is also used in combination with other chemotherapy agents for the
treatment of other cancers, including ovarian, non-small cell lung, and breast
cancer.
Olav Hellebø, Clavis CEO, commented: "We believe there are many cancer patients
who are not receiving optimal treatment from nucleoside drugs because of low
levels of the required transporter proteins on cancer cells leading to
insufficient cellular uptake. Nucleoside drugs, such as gemcitabine and
cytarabine, are long established as one of first lines of treatment and their
effects are significantly diminished by low levels or absence of hENT1. We are
therefore very pleased by the development announced today. This is a significant
step in the development of CP-4126 in pancreatic cancer, and will allow our
commercial partner Clovis Oncology to select patients that will have greatest
benefit from treatment with CP-4126 in future clinical trials."
For further details, please see
http://www.prnewswire.com/news-releases/clovis-oncology-inc-signs-an-agreement-w
ith-ventana-medical-systems-to-develop-companion-diagnostic-test-for-co-101-9180
3299.html
For Further Information Contact:
For Clavis Pharma
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
+44 7833904901 (mob)
olav.hellebo(at)clavispharma.com
Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum(at)clavispharma.com
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma(at)citigatedr.co.uk
About CP-4126
CP-4126 is a novel, patented, lipid-conjugated form of the well-established
cancer drug gemcitabine (Gemzar®) that has the potential to improve treatment
outcomes in patients with pancreatic cancer as other solid tumours who have low
levels of hENT1.
CP-4126 will shortly be directly compared to gemcitabine in an international,
randomised, controlled trial in patients newly diagnosed with metastatic
pancreatic cancer. The study will enroll approximately 250 patients, randomized
between gemcitabine and CP-4126, and measures overall survival (OS) in
prospectively-defined hENT1-low patients as the primary endpoint. Expression of
hENT1 in tumour tissue will be measured during the trial and patients
categorized into hENT1-high or hENT1-low groups prior to final analysis. This
study is a prospective test of two hypotheses: (1) that low pancreatic tumor
hENT1 expression is associated with poor outcome after gemcitabine therapy, and
(2) that CP-4126 has superior efficacy (measured by OS) in hENT1-low patients
compared with gemcitabine. This trial will commence enrollment in the second
quarter of 2010, and data from this trial are expected in the first half of
2012.
CP-4126 has been granted orphan drug status for the treatment of pancreatic
cancer in both the U.S. and the European.
About Pancreatic Cancer
Pancreatic cancer presents a major unmet medical need due to the poor survival
outcomes and limited number of therapeutic options available to patients.
Approximately 37,000 new cases of pancreatic cancer were recorded in the US in
2007. The 1-year and 5-year overall survival rates are estimated at 23% and
4%, respectively. The majority of pancreatic cancer patients are diagnosed with
locally advanced (unresectable) or metastatic disease. Median overall survival
in these advanced patients is 4-10 months.
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
cancer;
* Oral CP-4126 - currently being evaluated in an escalating dose Phase I study
in solid tumours; and
* CP-4200, an azacitidine derivative - in preclinical development for
myelodysplastic syndrome (MDS), often a precursor to myeloma or 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:
CLAVIS).
Disclaimer
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 provided
herein, and no claims shall be made by the recipient hereof by virtue of this
News Announcement or the information contained herein.
Clavis Pharma(TM) is a registered trademark of Clavis Pharma ASA.
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This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1407041]
Agreement_ between_ Clovis_Oncology_and_Ventana_ Medical_Systems: http://hugin.info/136972/R/1407041/360369.pdf
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