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."