Clavis Pharma - Third Quarter Report 2010
(Thomson Reuters ONE) -
Oslo, Norway, October 21, 2010
Clavis Pharma ASA (OSE: CLAVIS); the Norwegian cancer drug development company,
announces today its results for the third quarter 2010, ended 30 September 2010
Highlights:
* CLAVELA, the pivotal Phase III trial investigating elacytarabine in late-
stage AML patients, enrolled its first patient in August and is progressing
according to plan with clinical sites opening and patient enrolment ongoing
in the US and Europe.
* The randomised Phase II study of CP-4126 (also known as CO-1.01) vs.
gemcitabine in pancreatic cancer patients, also enrolled its first patient
in August and is progressing as planned with clinical sites opening and
patient enrolment ongoing in Europe, US, South America and Australia.
* A protocol has been submitted to the FDA for a new clinical trial with CP-
4126 in second-line pancreatic cancer patients, and a retrospective
observational study to define the criteria for low/high hENT1 expression
levels is in preparation.
* The pre-clinical toxicology programme for CP-4200, a potential new treatment
of solid tumours and haematological malignancies, is progressing according
to plan.
* Research and development costs and other operating expenses amounted to
NOK 39 million in the third quarter of 2010.
* The Company had cash and cash equivalents of NOK 169 million as of 30
September 2010.
Olav Hellebø, CEO of Clavis Pharma, said: "Clavis Pharma has made very good
progress during the first nine months of 2010 and has advanced all three of its
current development programmes. The Company's activities over the next 6-12
months will be focused on enrolling patients into its clinical studies as
quickly and efficiently as possible. In addition, the Company hopes to complete
the pre-clinical toxicology studies with CP-4200 and initiate clinical Phase I
studies in the first half of 2011. Furthermore, Clavis Pharma is continuing
discussions with potential partners for its programmes, especially CP-4126 in
Asia."
The Third Quarter Report and Presentation are available on www.clavispharma.com.
Contact:
Olav Hellebø, CEO
Office: +47 24 11 09 65 / Mobile: +44 783 390 4901
E-mail:olav.hellebo(at)clavispharma.com
Gunnar Manum
Chief Financial Officer
Office: +47 24 11 09 71/ Mobile: +47 95 17 91 90
E-mail:gunnar.manum(at)clavispharma.com
For international press enquiries:
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
Office: +44 207 282 2948
E-mail:clavispharma(at)citigatedr.co.uk
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 optimised form of cytarabine, a leukaemia drug - currently
in Phase III, a randomized, controlled registration study in late-stage
acute myeloid leukaemia;
* CP-4126, an improved version of gemcitabine - currently in a Phase II
comparative study with gemcitabine for the treatment of pancreatic cancer;
* 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:
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. 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 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.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1453740]
Third Quarter Financial Report 2010:
http://hugin.info/136972/R/1453740/394220.pdf
Third Quarter Presentation 2010:
http://hugin.info/136972/R/1453740/394221.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Clavis Pharma ASA via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 21.10.2010 - 07:01 Uhr
Sprache: Deutsch
News-ID 45971
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contact information:
Town:
Oslo
Kategorie:
Business News
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