OSLO, NORWAY--(Marketwire - December 07, 2009) - Elacytarabine demonstrated threefold survival
benefit in patients
with acute myeloid leukaemia
Clavis Pharma ASA (OSE: CLAVIS) announces that positive clinical data
from its Phase II study with its lead cancer product candidate
elacytarabine in patients with late-stage acute myeloid leukaemia
(AML) was presented at the 51st American Society of Hematology (ASH)
Annual Meeting in New Orleans, LA, USA. Elacytarabine is a novel,
patented, lipid-conjugated form of the anti-cancer drug cytarabine
(Ara-C) that has the potential to improve treatment outcomes in
patients with AML and other haematological malignancies (leukaemias).
Elacytarabine has Orphan Drug Designation in the USA and Europe for
the treatment of AML.
The poster entitled "A Phase II Multicenter Study with Elacytarabine
as Second Salvage Therapy in Patients with AML" was presented by
Susan O'Brien, M.D. of the University of Texas MD Anderson Cancer
Center, Houston, TX, in collaboration with researchers at other
leading cancer centres and Clavis Pharma. This is the first time
clinical results of this trial for all 61 patients have been
presented at a leading cancer congress.
The poster can be downloaded from
http://www.clavispharma.com/Products/Scientific+posters.
The data and analyses from the multicentre open-label trial showed
elacytarabine to have a significantly superior survival benefit
compared to published clinical outcome data for 594 late-stage AML
patients receiving investigators choice of treatment[1]. The results
confirm the positive findings from the trial announced in June 2009.
Key results for elacytarabine compared to published clinical data are
* Median survival three times longer (5.3 months vs. 1.5 months)
* Remission rate significantly increased (14.8% vs 2.5%, p < 0.0001)
* Well tolerated - short-term mortality substantially lower (13%
vs. 25%)
Based on the encouraging results of this trial, Clavis Pharma is
about to begin a 350-patient Phase III randomised, controlled
registration study in the USA and Europe designed to demonstrate its
superiority over the investigator's choice of the best alternative
therapy in late-stage AML patients.
Clavis Pharma has also received approval to enrol patients in a Phase
II study of elacytarabine in combination with idarubicin in AML
patients who have failed their first course of treatment.
In addition to evaluating survival in all patients, the studies will
analyze patients' expression levels of the hENT1 tumour protein. The
hENT1 (human equilibrative nucleoside transporter 1) cell membrane
transporter is believed to be critical for cytarabine entry into
tumour cells, whereas elacytarabine enters and kills tumour cells in
a hENT1-independent manner. The goal is to demonstrate that the
efficacy of elacytarabine is independent of the patient's hENT1
status.
Geir Christian Melen, CEO of Clavis Pharma, commented: "These
positive clinical results give us great confidence that elacytarabine
could improve the treatment of late-stage AML patients, a group for
which there are few effective therapeutic options. We look forward to
starting a randomised, controlled Phase III trial to further
demonstrate the benefit that we have already seen with elacytarabine
in treating these patients.
Mr Melen added, "The results represent an important proof of concept
for our approach to developing improved cancer drugs based on our
Lipid Vector Technology. This approach was recently validated in our
$380 million deal with Clovis Oncology for CP-4126 to treat
pancreatic and other solid tumours. Both elacytarabine and CP-4126
are designed using LVT to bypass the hENT1 transporter mechanism that
limits the efficacy of cytarabine and gemcitabine, respectively. We
are excited about the potential of both these drugs and also that, as
a result of the deal with Clovis, sufficient resources are available
to drive the clinical programmes forward."
Extended survival, improved remissions
In the Phase II study, 61 patients (41 male and 20 female) with late
stage AML who failed to respond or relapsed after two separate rounds
of treatments received third-line therapy (also called second
salvage) with intravenous elacytarabine. A dose of 2000 mg/m2/day was
given as continuous infusion for five days. The response to treatment
was compared with a detailed historical outcome analysis of 594
similar second salvage AML patients, who were treated at the MD
Anderson Cancer Center (Houston, TX, USA) (published by Giles et al,
Cancer 2005;104:547-54). Median overall survival in the elacytarabine
study was an impressive three times that of the historical control
patients (5.3 months vs. 1.5 months). The 6 month survival rate was
44%.
In addition, 9 patients responded to elacytarabine with a complete
remission (CR) or complete remission without full recovery of
platelet counts (CRp) as assessed by the investigator, representing
an overall remission rate of 14.8 per cent. By contrast, the expected
remission rate for similar group of patients, matched for prognostic
factors as described by Giles et al. was only 2.5 per cent. Using a
pre-defined statistical analysis method, the improvement in outcome
was statistically highly significant (corresponding to p < 0.0001). In
addition to the 9 patients with a complete remission, 5 patients
responded to elacytarabine with a partial response.
Elacytarabine was relatively well tolerated, also by elderly
patients, and 30 day all cause mortality following treatment was
substantially lower than published data for existing therapies (13
per cent vs. 25 per cent). Out of the 61 patients treated with
elacytarabine, 10 were referred for stem cell transplantation
following treatment, including some patients in complete remission
and others with a more modest level of clinical benefit. Stem cell
transplantation represents a potential cure for life for these
patients.
For further information, please 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
NOTES FOR EDITORS
About Leukaemia
Approximately 300,000 new cases of leukaemia are diagnosed globally
each year, resulting in around 220,000 deaths. Leukaemia represents a
market with high unmet medical needs, which may open for accelerated
approval processes to expedite market access for new drugs. It is a
segmented market covering a broad variety of disorders. A major
clinical concern is the high rate of disease recurrence. The
five-year survival for the most common acute leukaemia type, acute
myeloid leukaemia (AML), is in the range of 5-10% for treated elderly
patients, and approximately 30% for treated younger adults. The AML
market is estimated to be a multi-hundred USD market and is expected
to grow significantly over the coming years.
About Clavis Pharma
Clavis Pharma ASA is a clinical stage oncology focused pharmaceutical
company based in Oslo, Norway with a portfolio of novel anti-cancer
drugs in development. These potential breakthough products are New
Chemical Entities (NCEs) made using Clavis Pharma's Lipid Vector
Technology (LVT) chemistry to introduce new properties to already
established, commercially successful drugs. Data generated suggests
the resulting patentable NCEs 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 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
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Theses factors include, among other things, risks associated with
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[1] Giles, F et al, Outcome of patients with acute myelogenous
leukemia after second salvage therapy. Cancer (2005)104: 547-554
Clavis Pharma Phase II Clinical Data Presented at ASH:
http://hugin.info/136972/R/1359425/331345.pdf
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