Chimerix Presents Updated Results from Phase 2 Clinical Trial of DSTAT in Refractory Myelodysplastic Syndrome and Acute Myelo...
December 10 2019 - 7:30AM
Chimerix, Inc. (Nasdaq: CMRX), a biopharmaceutical company focused
on accelerating the development of medicines to treat cancer and
other serious diseases, today announced that data relating to its
dociparstat sodium (DSTAT) program, formerly known as CX-01, were
presented at the 61st American Society of Hematology Annual
Meeting, in Orlando, FL.
The poster, titled “Updated Study Results for
CX-01, an Inhibitor of CXCL12/CXCR4, With Azacitidine for the
Treatment of Hypomethylating Agent Refractory AML and MDS,” was
presented by Eric Huselton, M.D., Assistant Professor of
Medicine at the University of Rochester on December 9, 2019.
As reported in the published study abstract, 20
patients with refractory myelodysplastic syndrome (MDS) (n = 9) or
refractory acute myeloid leukemia (AML) (n = 11) were enrolled of
which 15 were considered evaluable for response with a bone marrow
biopsy after cycle 2. Patients received a 7-day continuous infusion
of DSTAT (CX-01) at a dose of 0.25 mg/kg/hour, and azacitidine 75
mg/m2 daily days 1-7, in 28-day cycles. The primary objective
of this trial was to assess the overall response rate. Half of the
patients had high risk cytogenetic abnormalities and 3 had TP53
mutations. Patients had a median of 2 prior lines of therapy
(range 1-3) with median of 6 prior cycles of hypomethylating agent
(HMA) therapy (range 4-20). Only 4 patients had a confirmed
response to prior HMA therapy.
The 15 evaluable patients received a median of 3
cycles of CX-01 and azacitidine (range 2-9). Of 15 evaluable
patients, there was 1 CR (complete remission) and 3 bone marrow CRs
(mCR, with incomplete peripheral blood count recovery), 9 stable
disease, and 2 progressive disease for an overall response rate of
27%. Of the 3 patients with a mCR after cycle 2, two had
hematologic improvement of their neutrophil and platelet counts,
respectively, by the end of cycle 4. A patient with stable
disease also had hematologic improvement in platelets.
The median overall survival of evaluable patients
was 221 days. The median overall survival was not significantly
different between AML patients at 221 days and MDS patients at 248
days.
“Following a minimum of 4 cycles of prior HMA
therapy, one would not expect to observe response to subsequent HMA
therapy,” said Dr. Huselton. “These results demonstrate DSTAT’s
potential to improve HMA therapy outcomes in terms of both response
and overall survival.”
"DSTATs mechanism of action is intended to enhance
patient benefit when combined with an active agent, so to observe
these results in HMA-refractory patients is promising. In addition
to our planned Phase 3 pivotal trial in newly diagnosed AML, this
study highlights the potential to develop DSTAT to enhance the
benefit of multiple therapies such as azacitidine, in AML and MDS
in both front-line and recurrent settings," said Mike Sherman,
Chief Executive Officer of Chimerix.
About Chimerix
Chimerix is a development-stage
biopharmaceutical company dedicated to accelerating the advancement
of innovative medicines that make a meaningful impact in the lives
of patients living with cancer and other serious diseases. The two
clinical-stage development programs are dociparstat sodium (DSTAT)
and brincidofovir (BCV).
Dociparstat sodium is a potential first-in-class
glycosaminoglycan biologic derived from porcine heparin that has
low anticoagulant activity but retains the ability to inhibit
activities of several key proteins implicated in the retention and
viability of AML blasts and leukemic stem cells in the bone marrow
during chemotherapy (e.g., CXCL12, selectins, HMGB1).
Mobilization of AML blasts and leukemic stem cells from the bone
marrow has been associated with enhanced chemosensitivity and may
be a primary mechanism accounting for the observed increases in EFS
and OS in Phase 2 with DSTAT versus placebo. Randomized Phase 2
data suggest that DSTAT may also accelerate platelet recovery
post-chemotherapy via inhibition of platelet factor 4, a negative
regulator of platelet production that impairs platelet recovery
following chemotherapy. BCV is a lipid conjugate DNA polymerase
inhibitor in development as a medical countermeasure for
smallpox. For further information, please visit the Chimerix
website,www.chimerix.com
CONTACT:
Investor Relations: Michelle LaSpaluto
919-972-7115ir@chimerix.com
Will O’ConnorStern Investor
Relations212-362-1200will@sternir.com
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