Onconova and Cellworks Announce Presentation of Rigosertib Predictive Signature for Clinical Response in Myelodysplastic Synd...
06 December 2016 - 11:01PM
Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage
biopharmaceutical company focused on discovering and developing
novel products to treat cancer and Cellworks, a customized therapy
design company that improves clinical outcomes and creates value
for pharma, payers and physicians, today announced the presentation
of their collaborative effort to identify higher-risk MDS (HR-MDS)
patients that are likely to respond to rigosertib at the 2016 ASH
Annual Meeting in San Diego California, taking place December 3-6,
2016.
The presentation by Dr. Guillermo Garcia-Manero
from the MD Anderson Cancer Center, lead investigator from the
ONTME trial, used Cellworks’ proprietary bio-simulation platform to
retrospectively correlate clinical benefit to IV rigosertib
treatment in the Phase 3 ONTIME study in HR-MDS patients with
molecular and cytogenetic data. This computer simulation led to the
characterization of certain biological pathways that predict
response to IV rigosertib in HR-MDS patients. Notably, patients
with these predictive biological pathways also shared common
cytogenetic abnormalities – trisomy of chromosomes 8 and 21 – that
correlated with positive clinical outcome in ONTIME.
“This retrospective analysis of ONTIME has
helped identify biological factors related to clinical outcomes to
treatment with IV rigosertib,” stated Guillermo Garcia-Manero, MD,
Chief of the Section of Myelodysplastic Syndromes at The University
of Texas MD Anderson Cancer Center, and lead author of the
study. “These results confirm prior studies where patients
with certain cytogenetic abnormalities were sensitive to IV
rigosertib. These data also reinforce the clinical strategy of the
ongoing Phase 3 INSPIRE trial to target only the highest-risk MDS
patients with rigosertib.”
“We are excited by this use of our proprietary
bio-simulation platform to predict response to novel therapeutics
in a heterogeneous disease like HR-MDS,” commented Yatin Mundkur,
CEO of Cellworks. “Among other applications, the Cellworks
platform is intended to inform the design of Phase 2 and 3 clinical
trials by establishing and validating inclusion criteria. In
this case, we are pleased that this analysis has validated
enrollment criteria for Onconova’s Phase 3 INSPIRE
trial.”
The poster entitled “Computational Analysis of
Genomic Abnormalities from a Phase 3 Trial of Rigosertib in
Higher-Risk MDS: Simulation of a Predictive Signature for Clinical
Response,” was presented on December 5, 2016 at the ASH Annual
Meeting in San Diego, California. A copy of the poster is
available by visiting the Scientific Presentations section under
the Investors & Media tab of Onconova’s website.
About Onconova Therapeutics,
Inc.
Onconova Therapeutics is a Phase 3
clinical-stage biopharmaceutical company focused on discovering and
developing novel products to treat cancer. Onconova's clinical and
pre-clinical stage drug development candidates are derived from its
extensive chemical library and are designed to work against
specific cellular pathways that are important in cancer cells,
while causing minimal damage to normal cells. The Company’s most
advanced product candidate, rigosertib, is a small molecule
inhibitor of cellular signaling and acts as a RAS mimetic. These
effects of rigosertib appear to be mediated by direct binding of
the compound to the RAS-binding domain (RBD) found in many RAS
effector proteins, including the Raf and PI3 kinases. Rigosertib is
protected by issued patents (earliest expiry in 2026) and has been
awarded Orphan Designation for MDS in the United States, Europe and
Japan. In addition to rigosertib, two other candidates are in
the clinical stage, and several candidates are in pre-clinical
stages. For more information, please
visit http://www.onconova.com.
About IV Rigosertib
The intravenous form of rigosertib has been
employed in Phase 1, 2, and 3 clinical trial involving more than
800 patients, and is currently being evaluated in the randomized
Phase 3 global INSPIRE trial as 2nd-line treatment for patients
with higher-risk MDS, after failure of hypomethylating agent, or
HMA, therapy. This formulation is suited for patients with advanced
disease and provides long duration of exposure and ensures adequate
dosing under a controlled setting.
About INSPIRE
The INternational
Study of Phase III
IV RigosErtib,
or INSPIRE, is based on guidance received from the U.S. Food
and Drug Administration and European Medicines Agency and derives
from the findings of the ONTIME Phase 3 trial. INSPIRE is a
multi-center, randomized controlled study to assess the efficacy
and safety of IV rigosertib in HR-MDS patients who had progressed
on, failed to respond to, or relapsed after previous treatment with
an HMA within the first nine months of initiation of HMA
treatment. This time frame optimizes the opportunity to
respond to treatment with an HMA prior to declaring treatment
failure, as per NCCN Guidelines. The trial will enroll
approximately 225 patients randomized at a 2:1 ratio into two
treatment arms: IV rigosertib plus Best Supportive Care versus
Physician’s Choice plus Best Supportive Care. The primary
endpoint of INSPIRE is overall survival and an interim analysis is
anticipated. Full details of the INSPIRE trial, such as
inclusion and exclusion criteria, as well as secondary endpoints,
can be found on clinicaltrials.gov (NCT02562443).
Forward Looking Statements
Some of the statements in this release are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995, which involve risks and
uncertainties. These statements relate to future events or Onconova
Therapeutics, Inc.'s future operations, clinical development of
Onconova's product candidates and presentation of data with respect
thereto, regulatory approvals, expectations regarding the
sufficiency of Onconova's cash and other resources to fund
operating expenses and capital expenditures, Onconova's anticipated
milestones and future expectations and plans and prospects.
Although Onconova believes that the expectations reflected in such
forward-looking statements are reasonable as of the date made,
expectations may prove to have been materially different from the
results expressed or implied by such forward-looking statements.
Onconova has attempted to identify forward-looking statements by
terminology including “believes,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “should,”
“approximately” or other words that convey uncertainty of future
events or outcomes. These statements are only predictions and
involve known and unknown risks, uncertainties, and other factors,
including Onconova’s need for additional financing and current
plans and future needs to scale back operations if adequate
financing is not obtained, the success and timing of Onconova’s
clinical trials and regulatory approval of protocols, and those
discussed under the heading “Risk Factors” in Onconova’s most
recent Annual Report on Form 10-K and quarterly reports on Form
10-Q.
Any forward-looking statements contained in this
release speak only as of its date. Onconova undertakes no
obligation to update any forward-looking statements contained in
this release to reflect events or circumstances occurring after its
date or to reflect the occurrence of unanticipated events.
CONTACT: Onconova Therapeutics
Benjamin Hoffman, 267-759-3036
bhoffman@onconova.us
CONTACT: Cellworks
Taher Abbasi, 408-467-3805
taher@cellworksgroup.com
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