Clavis Pharma's CP-4126 Enters New Phase II Clinical Trial in Pancreatic Cancer Patients Refractory to 1st line Gemcitabine Therapy
(Thomson Reuters ONE) -
Oslo, Norway , February 2, 2011
Clavis Pharma (OSE: CLAVIS), the Norwegian cancer drug development company,
announces that its partner, Clovis Oncology, Inc., has recruited the first
patient into a Phase II clinical study (CO-101-003 study) with CP-4126 (also
known as CO-101). This trial will investigate the use of CP-4126 as a 2(nd) line
treatment for advanced, metastatic pancreatic cancer in patients refractory to
1(st) line gemcitabine treatment, where the mechanism of resistance is likely to
be due to impaired drug entry into tumour cells.
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 non-small cell lung, ovarian, gastro-intestinal and
breast cancer. The entry of gemcitabine into tumour cells has been shown to be
dependent upon the expression of specific membrane transporter proteins,
particularly hENT1 (human Equilibrative Nucleoside Transporter 1). It is
estimated that, owing to deficient expression of the hENT1, at least 50% of
patients with pancreatic tumours have limited cellular uptake of gemcitabine and
therefore respond poorly to treatment. Published research has also suggested
that hENT1 levels correlate with outcomes in lung cancer patients treated with
gemcitabine-containing chemotherapy.[1],[2],[3]
CP-4126 is a novel, patented, lipid-conjugated derivative of the anti-cancer
drug gemcitabine, developed using Clavis' lipid vector technology (LVT). Due to
its different molecular design, CP-4126 is absorbed by cancer cells independent
of hENT1 levels, which may lead to an improvement in efficacy in the poorly-
served group of patients with no or low hENT1 expression.
The CO-101-003 study is a 35-patient, single arm, Simon 2- stage, Phase II
multicentre study that will be conducted at US sites. Patients with advanced,
metastatic pancreatic cancer will be eligible for inclusion if they were
refractory to 1(st) line gemcitabine treatment (gemcitabine-refractory) AND
their tumours show no expression of hENT1. The primary objective of this study
is to determine disease control rate (DCR or best response of complete response
[CR], partial response [PR], or stable disease [SD]). CP-4126 treatment will
continue will continue until tumour progression or toxicity occurs.
CP-4126 is also being evaluated as a 1(st) line therapy in a head-to-head
comparison with gemcitabine in an ongoing Phase II, pivotal trial (study CO-
101-001).
"This is a very challenging test of the ability of CP-4126 to overcome hENT1
related resistance to gemcitabine," said Eileen M. O'Reilly, MD, Memorial Sloan-
Kettering Cancer Center. "Patients whose cancer fails to respond at all to
gemcitabine progress rapidly. There are no approved therapies for patients whose
disease progresses on gemcitabine therapy. It would be very encouraging if we
are able to at least stabilize the disease in this very difficult to treat group
of patients," she added.
Olav Hellebø, CEO of Clavis Pharma, said: "This is another significant step
forward in the clinical development of CP-4126 and we are delighted with the
progress made by our partner Clovis Oncology."
References
1. Farrell J, Elsaleh H, Garcia M, Lai R, Ammar A, et al. Human ENT1 levels
predict responseto gemcitabine in patients with pancreatic cancer.
Gastroenterology, 2009;136:187-195.
2. Giovannetti E, Del Tacca M, Mey V, Funel N, Nannizzi S, et al. Transcription
analysis of human equilibrative nucleoside transporter-1 predicts survival in
pancreas cancer patients treated with gemcitabine. Cancer Res,
2006;66:3928-3935.
3. Spratlin J, Sangha R, Glubrecht D, Dabbagh L, Young JD, et al. The absence of
human equilibrative nucleoside transporter 1 is associated with reduced survival
in patients with gemcitabine-treated pancreas adenocarcinoma. Clin Cancer Res,
2004;10:6956-6961.
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 43,000 new cases of pancreatic cancer will occur in the US in
2010, with a similar number occurring in Europe. 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 unresectable locally advanced or
metastatic disease. Median overall survival in these advanced patients is 4-10
months. CP-4126 has been granted orphan drug designations for the treatment of
pancreatic cancer in the US and EU.
Clinical Development of CP-4126
Following the Phase I study performed by Clavis Pharma, Clovis Oncology
initiated an international, randomised, Phase II, pivotal trial of CP-4126
versus gemcitabine in mid-2010, with overall survival as a primary endpoint. The
trial is progressing as planned with clinical sites opening and patient
enrolment ongoing in Europe, the US, South America and Australia. Results of
this trial are anticipated in 2012. While the trial is evaluating CP-4126 in
patients who express either high or low levels of the hENT1 biomarker, the
primary analysis will be overall survival in the hENT1-low population. If
successful, Clovis Oncology anticipates filing for marketing approval in the
United States and in the EU by year end 2012.
Clovis Oncology has signed an agreement with Ventana Medical Inc., a subsidiary
of Roche, to develop and commercialise the novel hENT1 biomarker diagnostic
method as a companion diagnostic for CP-4126.
For Further Information Contact:
For Clavis Pharma
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
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 Clavis Pharma
Clavis Pharma ASA is a 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 Phase II comparative study with gemcitabine for
the 1(st) line treatment of pancreatic cancer and a Phase II trial for
2(nd) line treatment for pancreatic cancer in patients refractory to 1(st)
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. CP-4126 is licensed to Clovis Oncology globally. Clavis Pharma has
an option to co-promote CP-4126 in Europe.
Disclaimer
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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.
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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.
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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
[HUG#1484596]
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Datum: 02.02.2011 - 10:13 Uhr
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News-ID 50960
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