Onconova Therapeutics, Inc. to Participate at the 31st Annual ROTH Conference March 17-19, 2019 in Orange County, CA
March 12 2019 - 7:30AM
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a
Phase 3-stage biopharmaceutical company focused on discovering and
developing novel products to treat cancer, with a primary focus on
myelodysplastic syndromes, today announced that the Company will
participate in the 31st Annual ROTH Conference to be held March
17-19, 2019 at the Ritz Carlton Laguna Niguel in Orange County, CA.
Steven M. Fruchtman, MD, President & CEO,
and Mark Guerin, CFO, will attend the conference and be available
to meet with investors. Dr. Fruchtman will also participate
on a panel to discuss myeloid diseases on Monday, March 18th, from
3:00-4:00p.
About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel small molecule drug candidates to treat cancer, with a
primary focus on Myelodysplastic Syndromes (MDS). Using a
proprietary chemistry platform, Onconova has created a pipeline of
targeted agents designed to work against specific cellular pathways
that are important in cancer cells. Onconova has three product
candidates in the clinical stage and several pre-clinical
programs. Advanced clinical trials with the Company’s lead
compound, rigosertib, are aimed at what the Company believes are
unmet medical needs of patients with MDS. For more
information, please visit http://www.onconova.com.
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule agent that, according to a
key publication, blocks cellular signaling by targeting RAS
effector pathways (Divikar, S.K., et al., 2016: "A Small Molecule
RAS-Mimetic Disrupts RAS Association with Effector Proteins to
Block Signaling." Cell 165, 643). Onconova is currently in the
clinic with oral and IV rigosertib, including single agent IV
rigosertib in 2nd line high-risk MDS patients (pivotal Phase 3
INSPIRE trial) and oral rigosertib plus azacitidine in 1st line
high-risk MDS patients (Phase 2).
About IV Rigosertib
The intravenous form of rigosertib has been
studied in Phase 1, 2, and 3 clinical trials involving more than
1000 patients, and is currently being evaluated in a randomized
Phase 3 international INSPIRE trial for patients with higher-risk
MDS, after failure of hypomethylating agent, or HMA, therapy.
About the INSPIRE Phase III Clinical Trial
The INternational
Study of Phase III
IV RigosErtib,
or INSPIRE, was finalized following guidance
received from the U.S. Food and Drug Administration and European
Medicines Agency. INSPIRE is a global 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 9 months or nine cycles over the course of one year after
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. Following interim
analysis in early 2018, which demonstrated a promising survival
signal in the intent-to-treat population as reviewed by the
independent Data Monitoring Committee, the Committee recommended
that the trial continue with an expansion in enrollment to 360
patients based on a pre-planned sample size re-estimation.
Patients are 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. Full details of the INSPIRE trial, such as
inclusion and exclusion criteria, as well as secondary endpoints,
can be found on clinicaltrials.gov (NCT02562443).
About Oral Rigosertib
The oral form of rigosertib was developed to
provide more convenient dosing for use where the duration of
treatment may extend to multiple years. This dosage form may also
support many combination therapy modalities. To date, over
400 patients have been studied with the oral formulation of
rigosertib. Combination therapy of oral rigosertib with
azacitidine, the standard of care in higher-risk MDS,
has also been studied. Currently, oral rigosertib is
being developed as a combination therapy together with azacitidine
for patients with higher-risk MDS who require HMA therapy. A
Phase 1/2 trial of the combination therapy has been fully enrolled,
and the preliminary efficacy and safety data was presented at the
American Society Meeting in December 2018. This novel combination
is the subject of an issued U.S. patent with earliest expiration in
2028.
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, and involve risks and uncertainties.
These statements relate to Onconova expectations regarding the
INSPIRE Trial and Onconova’s other development plans. Onconova has
attempted to identify forward-looking statements by terminology
including "believes," "estimates," "anticipates," "expects,"
"plans," "intends," "may," "could," "might," "will," "should,"
"approximately" or other words that convey uncertainty of future
events or outcomes. 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. These statements are only predictions
and involve known and unknown risks, uncertainties, and other
factors, including Onconova's ability to continue as a going
concern, the need for additional financing, 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.
General Contact
Avi OlerOnconova Therapeutics, Inc.
267-759-3680http://www.onconova.com/contact/
Onconova Therapeutics (NASDAQ:ONTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Onconova Therapeutics (NASDAQ:ONTX)
Historical Stock Chart
From Sep 2023 to Sep 2024