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Successful Investigational New Drug application (IND) Review for Intravenous CP-4126
Jul 03, 2009 (Hugin via COMTEX) --
Oslo, Norway, 3 July 2009 - Clavis Pharma ASA (OSE: CLAVIS) announces
today that it has received clearance by the United States Food and
Drug Administration (FDA) to include patients in the USA in its phase
II clinical programme for Intravenous CP-4126. Intravenous CP-4126 is
in development as a new, first-line treatment for pancreatic cancer
and the phase II program has already been initiated in Europe. Clavis
Pharma will now begin preparations at selected clinical sites for an
expansion of the phase II programme into the USA.
Intravenous CP-4126 is based on Clavis Pharma's proprietary Lipid
Vector Technology (LVT) and aimed at improving the therapeutic
profile of the current standard treatment for advanced pancreatic
cancer, gemcitabine (Gemzar(R)). Currently it is estimated that
pancreatic tumours in up to two-thirds of patients have a deficient
cellular uptake of gemcitabine due to deficient expression of a
necessary transport protein, hENT1 (human equilibrative nucleoside
transporter 1) on the tumour cell membrane1. This is known to limit
the efficacy of gemcitabine treatment in these patients. In contrast,
cellular uptake of Intravenous CP-4126 is independent of hENT1, which
offers a potential clinical advantage for the product in the
treatment of pancreatic cancer. In the phase II programme, cancer
tissue (biopsies) from each patient will be collected and analysed
with regard to levels of hENT1. The relation between response to
treatment and hENT1 levels will be studied.
"Our phase II programme for Intravenous CP-4126 follows the
successful completion of a phase I study in solid tumour cancer
patients. This earlier trial, in line with preclinical data, suggests
that CP-4126 may be of clinical benefit for patients that do not
respond to gemcitabine as well as those that currently benefit from
gemcitabine," says Geir Christian Melen, CEO of Clavis Pharma. "The
acceptance of the IND is an important milestone for us that
acknowledge our data on file for Intravenous CP-4126 and may enable
us to accelerate our phase II programme through expansion in the
USA."
Contact:
Geir Christian Melen
Chief Executive Officer
Office : +47 24 11 09 50
Mobile : +47 91 30 29 65
E-mail : geir.christian.melen@clavispharma.com
Gunnar Manum
Chief Financial Officer
Office : +47 24 11 09 71
Mobile : +47 95 17 91 90
E-mail : gunnar.manum@clavispharma.com
For international press enquiries:
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
Office : +44 207 282 2948
E-mail : clavispharma@citigatedr.co.uk
1 Ref: Giovannetti et al., Cancer Research 66, 3928-3935, April 1,
2006
About Intravenous CP-4126
CP-4126 is a novel Lipid Vector Technology analogue of gemcitabine
(Gemzar(R)), one of the world's leading cancer drugs, used in the
treatment of several cancers, such as pancreatic cancer, ovarian
cancer and non-small cell lung cancer. Gemzar is a blockbuster cancer
drug, with 2008 sales of USD 1.7 billion. Clavis Pharma is developing
Intravenous CP-4126, which has a different therapeutic profile and
may potentially have effect in patients who are resistant or
refractory to gemcitabine treatment.
About Pancreatic cancer
Pancreatic cancer is a very serious disease and an indication with a
high unmet medical need. Approximately 37,000 new cases of pancreatic
cancer were recorded in the USA in 2007. The 1-year and 5-year
overall survival rates are estimated at 23% and 4%, respectively. The
majority of these patients have unresectable disease or will recur
after surgery. Median overall survival in these patients is
approximately 8-12 months. The standard first-line therapy for
patients with unresectable disease is gemcitabine monotherapy.
Unfortunately, many of these patients fail to benefit from treatment.
About Clavis Pharma
Clavis Pharma ASA is an oncology focused pharmaceutical company using
its proprietary Lipid Vector Technology (LVT) platform to create New
Chemical Entities (NCEs), by significantly improving already
established drugs. The improvements are achieved by chemically
binding specific unsaturated lipids to existing, and well understood,
approved pharmaceuticals. Data generated suggests the resulting
patentable NCEs offer improved efficacy and reduced side effects
through enhanced pharmacokinetic properties, greater tissue
penetration and, in many cases, additional modes of action.
Clavis Pharma's objective is to develop its drug candidates until
significant value has been created and proof of principle in man has
been shown. For further clinical development and commercialisation of
the products, Clavis Pharma will enter into strategic partnerships
with established pharmaceutical or biotech companies. The company's
product portfolio includes four new cancer drugs: Elacytarabine
[pINN] and Intravenous CP-4126 are in Clinical phase II, Oral CP-4126
in phase I, and CP-4200 is in early preclinical development. Results
indicate that these products have promising potential for several
cancer indications within solid tumours and leukaemia.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange
(ticker: CLAVIS).
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.
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 or projections provided herein, and no claims shall be
made by the recipient hereof by virtue of this Information Memorandum
or the information or projections contained herein. Any
representations or warranties made to an investor in Clavis Pharma
will be subject to separate sale and purchase agreements to be
negotiated between the parties.
Clavis Pharma is a registered trademark of Clavis Pharma ASA.
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
SOURCE: Clavis Pharma ASA
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