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8-K - 8-K - ARRAY BIOPHARMA INC | v327412_8-k.htm |
Array BioPharma To Present Clinical Data At The 2012 ASH Meeting On ARRY-520, A KSP Inhibitor, And ARRY-614, A Dual p38/Tie2 Inhibitor
Conference call scheduled today, Monday, November 5, 2012 at 4:30 p.m. ET
BOULDER, Colo., Nov. 5, 2012 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) today announced that data will be presented on two drug candidates, ARRY-520, a KSP inhibitor, and ARRY-614, a dual p38/Tie2 inhibitor, at the 2012 Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia. Array will also hold a conference call today, Monday, November 5, 2012 at 4:30 p.m. ET, to review the abstracts. The call-in details are provided below.
(Logo: http://photos.prnewswire.com/prnh/20121029/LA02195LOGO)
Ron Squarer, Chief Executive Officer of Array, noted, "We are excited to present clinical results for ARRY-520 and ARRY-614 at the upcoming ASH annual meeting. Notably, our oral presentation will show that in patients with triple-refractory multiple myeloma and a median number of 10 prior treatment regimens, ARRY-520 plus low-dose dexamethasone has a 22% overall response rate (>PR), with manageable safety. This response rate is comparable to those reported for pomalidomide or carfilzomib even though their studies included patients with only half the number of prior median treatment regimens. In a related abstract assessing the same group of ARRY-520-treated patients, we observed that prospective screening for the acute phase protein alpha-1-acidic glycoprotein, or AAG, may enable us to better select patients who will respond to treatment with ARRY-520. For patients with a non-elevated AAG level, the overall response rate (>PR) increased to 33%. We believe these observed overall response rates in a heavily pre-treated patient population with limited treatment options defines a potential regulatory path to approval for ARRY-520."
ARRY-520 is currently advancing in three clinical trials. Positive results in any one of these trials will define a clear path to late stage development:
- Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid® (lenalidomide), Velcade® (bortezomib) and dexamethasone therapy.
- Phase 1b trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM.
- Phase 1b investigator-sponsored trial in combination with Kyprolis® (carfilzomib) in patients with relapsed or refractory MM who are refractory or intolerant to Velcade therapy.
Early data from the ongoing combination with carfilzomib is reported in the abstract listed below. As noted in the abstract, updated safety and efficacy data for all patients will be presented at the meeting.
In the ARRY-614 abstract listed below, our new formulation demonstrated improved bioavailability and inter-patient variability with in our ongoing study in low or intermediate-1 risk Myelodysplastic Syndromes (MDS). In our prior study in a similar population, we observed a 38% response rate for hematologic improvement in patients receiving the highest dose of our prior formulation. At this dose, ARRY-614 demonstrated multilineage hematologic improvement in 67% of the responders, improving two or more cytopenia (neutropenia, thrombocytopenia and/or anemia). Array intends to meet with the FDA to discuss the development plan to support registration.
The abstracts can also be accessed through the American Society of Hematology website, www.hematology.org/Meetings/Annual-Meeting. After the presentations, the posters and presentation slides will be available as PDFs on Array's website at www.arraybiopharma.com. ASH is the world's largest professional society concerned with the causes and treatments of blood disorders, and presentation of clinical trial results at the annual conference marks an important strategic milestone in the continued development of these two drugs.
ARRY-520 - KSP inhibitor for Multiple Myeloma (MM):
Three abstracts will be presented on ARRY-520,
including one oral presentation:
Title: The Novel KSP Inhibitor
ARRY-520 Is Active Both with and
without Low-Dose Dexamethasone in
Patients with Multiple Myeloma Refractory
to Bortezomib and Lenalidomide: Results
From a Phase 2 Study
Date:
Monday, December 10, 2012
Time: 11:30 a.m. ET (oral
presentation)
Room: Georgia
World Congress Center, Thomas Murphy
Ballroom 2-3
Summary: Patients
with relapsed refractory multiple
myeloma (RRMM) refractory to both
IMiD and proteasome inhibitor therapy
have a poor prognosis with median
survival of as little as 6 months.
New drugs with clinically meaningful
activity in this population are needed.
ARRY-520 is a novel agent with a
distinct mechanism of action relative
to other myeloma drugs and shows
promising clinical activity both
alone and combined with dexamethasone
in RRMM. Notably, in patients with
triple-refractory MM, ARRY-520 +
LoDex has shown a preliminary 28%
overall response rate (>MR),
with a manageable safety. These data
are comparable to those reported
for pomalidomide or carfilzomib in
less heavily pretreated patients.
Title: Phase 1 Study of the Novel Kinesin Spindle Protein Inhibitor ARRY-520 + Carfilzomib in Patients with Relapsed and/or Refractory Multiple
Myeloma
*Inclusion of additional patients and updated data for this trial will be presented during the presentation at ASH.
Date: Monday, December 10, 2012
Time: 6:00 PM - 8:00 p.m. ET
Room: Georgia World Congress Center, Hall B1-B2
Summary: The combination of ARRY-520 and carfilzomib is well tolerated with limited hematologic toxicity and a manageable side effect profile. Notably, in this patient population, with patients who have bortezomib refractory/intolerant myeloma, the combination has demonstrated early signals of activity. Updated safety and efficacy data for all patients will be presented at the meeting.
Title: Identification of Alpha 1-Acid Glycoprotein (AAG) As a Potential Patient Selection Biomarker for Improved Clinical Activity of the Novel KSP Inhibitor ARRY-520 in Relapsed and Refractory Multiple Myeloma (MM)
Date: Saturday, December 8, 2012
Time: 5:30 PM - 7:30 p.m. ET
Room: Georgia World Congress Center, Hall B1-B2
Summary: Our preliminary data suggest that AAG levels can affect the free fraction of ARRY-520 in blood over a clinically relevant range both preclinically and in clinical studies. In retrospective analysis, patients with higher AAG levels show a lower fu and therefore may not achieve sufficient exposure to gain therapeutic benefit from ARRY-520. In preclinical analyses, this effect is specific to ARRY-520, suggesting that AAG levels may be predictive for ARRY-520 activity relative to other MM drugs. We hypothesize that prospective screening for AAG may enable exclusion of patients who may not achieve therapeutic exposure to ARRY-520, increasing the overall activity of ARRY-520 and preventing exposure of non-responders to an ineffective therapeutic dose.
ARRY-614
–
Dual
p38/Tie2
inhibitor
for
Myelodysplastic
Syndromes
(MDS):
Array
will
also
be
presenting
the
following
abstract
from
a
Phase
1
clinical
trial
in
patients
with
MDS
using
an
optimized
formulation
of
ARRY-614
with
improved
plasma
exposure
and
lower
inter-subject
variability:
Title:
Role
of
p38
MAPK
and
Tie2
in
the
Pathogenesis
of
MDS
and
Their
Inhibition
by
Dual
Inhibitor
ARRY-614
Date:
Sunday,
December
9,
2012
Time:
6:00
PM
-
8:00
p.m.
ET
Room:
Georgia
World
Congress
Center,
Hall
B1-B2
Summary:
In
cell-based
assays,
ARRY-614
inhibits
both
p38-mediated
HSP27
phosphorylation
(IC50
=
1
nM)
and
Tie2-dependent
AKT
phosphorylation
(IC50
=
13
nM).
Cellular
IC50
values,
corrected
for
plasma
protein
binding,
and
preliminary
pharmacokinetic
parameters
were
used
to
predict
inhibition
of
these
targets
in
patients.
Analysis
of
the
highest
administered
dose
(1200
mg
QD)
of
ARRY-614
as
a
powder-in-capsule
(PiC)
formulation
in
the
Phase
1
clinical
study
predicted
robust
suppression
of
phospho-p38
(>50%
for
24
hours),
consistent
with
bone
marrow
and
plasma
biomarker
findings.
However,
partial
inhibition
of
Tie2
(>50%
for
17.1
hours)
was
predicted.
In
a
second
Phase
1
clinical
study,
an
optimized
ARRY-614
formulation
has
demonstrated
decreased
intra-
and
inter-patient
variability
and
increased
peak
plasma
concentrations.
With
this
new
formulation,
peak
plasma
concentrations
of
the
400
mg
QD
cohort
were
~50%
higher
than
those
of
the
1200
mg
QD
PiC
formulation
cohort,
possibly
affording
more
extensive
Tie2
inhibition.
These
observations
suggest
that
inhibition
of
both
p38
and
Tie2
may
be
important
for
the
effects
of
ARRY-614
in
MDS
patients.
The
ongoing
Phase
1
dose
escalation
trial
of
the
optimized
ARRY-614
formulation
may
further
our
understanding
of
the
contributions
of
these
targets
to
the
pathogenesis
of
MDS.
Conference Call Information
Date: Monday, November 5, 2012
Time: 4:30 p.m. Eastern Time
Toll-Free: (888) 895-5479
Toll: (847) 619-6250
Pass Code: 33684333
Webcast & Conference Call Slides: http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-irhome
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer. Array is evolving into a late-stage development company, with two wholly-owned programs, ARRY-614 and ARRY-520, and three partnered programs, selumetinib (with AstraZeneca), MEK162 (with Novartis), and danoprevir (with InterMune / Roche), having the potential to begin Phase 3 or pivotal trials by the end of calendar year 2013. For more information on Array, please go to www.arraybiopharma.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the timing of the announcement of the results of clinical trials for our proprietary and our partnered programs, the timing of the completion or initiation of further development of our wholly-owned and our partnered programs, expectations that events will occur that will result in greater value for the Company, the potential for the results of ongoing preclinical and clinical trials to support regulatory approval or the marketing success of a drug candidate, our ability to partner our proprietary drug candidates for up-front fees, milestone and/or royalty payments, our future plans to progress and develop our proprietary programs and the plans of our collaborators to progress and develop programs we have licensed to them, and our plans to build a late-stage development company. These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, our ability to continue to fund and successfully progress internal research and development efforts and to create effective, commercially viable drugs; risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates; the ability of our collaborators and of Array BioPharma Inc. to meet objectives tied to milestones and royalties; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties on their drug discovery activities; our ability to out-license our proprietary candidates on favorable terms; and our ability to attract and retain experienced scientists and management. We are providing this information as of November 5, 2012. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.
CONTACT: | Tricia Haugeto |
(303) 386-1193 | |
thaugeto@arraybiopharma.com |