ASH News Daily 2017 - Issue 3 - C-25

A Phase 3 study of pracinostat
(an HDAC inhibitor) in combination
with azacitidine in patients with

ASH Central
ails Pavillion

See page C-18

A Phase 2 study of pracinostat
in combination with azacitidine
in patients with

AML unfit for induction high/very high risk
MDS requiring therapy
chemotherapy
Now enrolling
Now enrolling

PRIMULA study

Pracinostat
+
Azacitidine
Patients with AML
unfit for induction
chemotherapy

N=500
Randomized 1:1

Placebo
+
Azacitidine

Primary endpoint: Overall Survival
Secondary endpoints: Morphologic Complete Remission (CR),
Cytogenetic Complete Remission (CRc), Complete Remission
without Minimal Residual Disease, Transfusion Independence
Key inclusion criteria:
* ≥ 18 years of age
* Newly diagnosed acute myeloid leukemia (AML)
* Unfit to receive intensive chemotherapy due to
- age ≥ 75 years, or
- comorbidities
* ≥ 20% blasts in bone marrow
* ECOG performance status ≤ 2
Location: approximately 140 sites in North and South America,
Europe, Asia Pacific
For additional information regarding the trial, or if you are interested in
becoming an Investigator, please contact us at:
pracinostatphase3@helsinn.com
ClinicalTrials.gov Identifier: NCT03151408

Stage 2
Patients with
high/very high
risk MDS
N=120

Stage 1 Pracinostat
+
Azacitidine

Pracinostat
+
Azacitidine
Placebo
+
Azacitidine

Primary endpoint: Overall Response Rate
Secondary endponts include: Complete Remission (CR),
Hematologic Improvement, Duration of Response,
Cytogenetic Response, Overall Survival, Event Free Survival
Key inclusion criteria:
* ≥ 18 years of age
* IPSS-R high or very high risk
myelodysplastic syndromes (MDS)
* Previously untreated with hypomethylating agents
* Clinical indication for treatment with azacitidine
* < 20% blasts in bone marrow
* ECOG performance status ≤ 2

For additional information regarding the trial, or if you are interested in
becoming an Investigator, please contact us at:
pracinostatMDSstudy@meipharma.com
ClinicalTrials.gov Identifier: NCT03151304

Pracinostat is an investigational agent and is not approved for commercial use by the FDA or any other worldwide regulatory agency.

To learn more, please visit Helsinn Booth #133



Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 3

ASH News Daily 2017 - Issue 3 - A-1
ASH News Daily 2017 - Issue 3 - A-2
ASH News Daily 2017 - Issue 3 - A-3
ASH News Daily 2017 - Issue 3 - A-4
ASH News Daily 2017 - Issue 3 - A-5
ASH News Daily 2017 - Issue 3 - A-6
ASH News Daily 2017 - Issue 3 - A-7
ASH News Daily 2017 - Issue 3 - A-8
ASH News Daily 2017 - Issue 3 - A-9
ASH News Daily 2017 - Issue 3 - A-10
ASH News Daily 2017 - Issue 3 - A-11
ASH News Daily 2017 - Issue 3 - A-12
ASH News Daily 2017 - Issue 3 - A-13
ASH News Daily 2017 - Issue 3 - A-14
ASH News Daily 2017 - Issue 3 - A-15
ASH News Daily 2017 - Issue 3 - A-16
ASH News Daily 2017 - Issue 3 - A-17
ASH News Daily 2017 - Issue 3 - A-18
ASH News Daily 2017 - Issue 3 - A-19
ASH News Daily 2017 - Issue 3 - A-20
ASH News Daily 2017 - Issue 3 - A-21
ASH News Daily 2017 - Issue 3 - A-22
ASH News Daily 2017 - Issue 3 - A-23
ASH News Daily 2017 - Issue 3 - A-24
ASH News Daily 2017 - Issue 3 - A-25
ASH News Daily 2017 - Issue 3 - A-26
ASH News Daily 2017 - Issue 3 - A-27
ASH News Daily 2017 - Issue 3 - A-28
ASH News Daily 2017 - Issue 3 - B-1
ASH News Daily 2017 - Issue 3 - B-2
ASH News Daily 2017 - Issue 3 - B-3
ASH News Daily 2017 - Issue 3 - B-4
ASH News Daily 2017 - Issue 3 - B-5
ASH News Daily 2017 - Issue 3 - B-6
ASH News Daily 2017 - Issue 3 - B-7
ASH News Daily 2017 - Issue 3 - B-8
ASH News Daily 2017 - Issue 3 - B-9
ASH News Daily 2017 - Issue 3 - B-10
ASH News Daily 2017 - Issue 3 - B-11
ASH News Daily 2017 - Issue 3 - B-12
ASH News Daily 2017 - Issue 3 - B-13
ASH News Daily 2017 - Issue 3 - B-14
ASH News Daily 2017 - Issue 3 - B-15
ASH News Daily 2017 - Issue 3 - B-16
ASH News Daily 2017 - Issue 3 - B-17
ASH News Daily 2017 - Issue 3 - B-18
ASH News Daily 2017 - Issue 3 - B-19
ASH News Daily 2017 - Issue 3 - B-20
ASH News Daily 2017 - Issue 3 - B-21
ASH News Daily 2017 - Issue 3 - B-22
ASH News Daily 2017 - Issue 3 - B-23
ASH News Daily 2017 - Issue 3 - B-24
ASH News Daily 2017 - Issue 3 - B-25
ASH News Daily 2017 - Issue 3 - B-26
ASH News Daily 2017 - Issue 3 - B-27
ASH News Daily 2017 - Issue 3 - B-30
ASH News Daily 2017 - Issue 3 - B-31
ASH News Daily 2017 - Issue 3 - B-32
ASH News Daily 2017 - Issue 3 - B-33
ASH News Daily 2017 - Issue 3 - B-34
ASH News Daily 2017 - Issue 3 - B-35
ASH News Daily 2017 - Issue 3 - B-36
ASH News Daily 2017 - Issue 3 - B-37
ASH News Daily 2017 - Issue 3 - B-38
ASH News Daily 2017 - Issue 3 - B-39
ASH News Daily 2017 - Issue 3 - B-40
ASH News Daily 2017 - Issue 3 - B-41
ASH News Daily 2017 - Issue 3 - B-42
ASH News Daily 2017 - Issue 3 - B-43
ASH News Daily 2017 - Issue 3 - B-44
ASH News Daily 2017 - Issue 3 - B-45
ASH News Daily 2017 - Issue 3 - B-46
ASH News Daily 2017 - Issue 3 - B-47
ASH News Daily 2017 - Issue 3 - B-48
ASH News Daily 2017 - Issue 3 - B-49
ASH News Daily 2017 - Issue 3 - B-50
ASH News Daily 2017 - Issue 3 - B-51
ASH News Daily 2017 - Issue 3 - B-52
ASH News Daily 2017 - Issue 3 - B-53
ASH News Daily 2017 - Issue 3 - B-54
ASH News Daily 2017 - Issue 3 - B-55
ASH News Daily 2017 - Issue 3 - B-56
ASH News Daily 2017 - Issue 3 - C-1
ASH News Daily 2017 - Issue 3 - C-2
ASH News Daily 2017 - Issue 3 - C-3
ASH News Daily 2017 - Issue 3 - C-4
ASH News Daily 2017 - Issue 3 - C-5
ASH News Daily 2017 - Issue 3 - C-6
ASH News Daily 2017 - Issue 3 - C-7
ASH News Daily 2017 - Issue 3 - C-8
ASH News Daily 2017 - Issue 3 - C-9
ASH News Daily 2017 - Issue 3 - C-10
ASH News Daily 2017 - Issue 3 - C-11
ASH News Daily 2017 - Issue 3 - C-12
ASH News Daily 2017 - Issue 3 - C-13
ASH News Daily 2017 - Issue 3 - C-14
ASH News Daily 2017 - Issue 3 - C-15
ASH News Daily 2017 - Issue 3 - C-16
ASH News Daily 2017 - Issue 3 - C-17
ASH News Daily 2017 - Issue 3 - C-18
ASH News Daily 2017 - Issue 3 - C-19
ASH News Daily 2017 - Issue 3 - C-20
ASH News Daily 2017 - Issue 3 - C-21
ASH News Daily 2017 - Issue 3 - C-22
ASH News Daily 2017 - Issue 3 - C-23
ASH News Daily 2017 - Issue 3 - C-24
ASH News Daily 2017 - Issue 3 - C-25
ASH News Daily 2017 - Issue 3 - C-26
ASH News Daily 2017 - Issue 3 - C-27
ASH News Daily 2017 - Issue 3 - C-28
ASH News Daily 2017 - Issue 3 - C-29
ASH News Daily 2017 - Issue 3 - C-30
ASH News Daily 2017 - Issue 3 - C-31
ASH News Daily 2017 - Issue 3 - C-32
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