Onconova Therapeutics, Inc. to Provide Corporate Update and Second Quarter 2017 Financial Results
08 August 2017 - 10:30PM
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
release its second quarter 2017 financial results on August 14,
2017 after the market closes. The Company will host a conference
call to discuss these results on August 15, 2017 at 9:00 a.m.
Eastern Time.
Interested parties may access the call by dialing toll-free
(855) 428-5741 from the US, or (210) 229-8823 internationally and
using conference ID 48705257.
The call will also be webcast live at:
http://investor.onconova.com/events.cfm.
A replay will be available at that link until November 30,
2017.
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). Rigosertib, Onconova's lead
candidate, is a proprietary Phase 3 small molecule agent,
which the Company believes blocks cellular signaling by
targeting RAS effector pathways. 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, while causing minimal damage to normal
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 IV Rigosertib
The intravenous form of rigosertib has been employed in Phase 1,
2, and 3 clinical trials involving more than 800 patients, and is
currently being evaluated in the randomized Phase 3 international
INSPIRE trial for patients with higher-risk MDS, after failure of
hypomethylating agent, or HMA, therapy. This formulation is
intended for patients with advanced disease, provides long
duration of exposure, and ensures 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 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. 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).
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 also supports many
combination therapy modalities. To date, 368 patients have been
treated with the oral formulation of rigosertib. Initial
studies with single-agent oral rigosertib were conducted in
hematological malignancies, lower-risk MDS, and solid tumors.
Combination therapy of oral rigosertib with azacitidine and
chemoradiotherapy has also been explored. 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 2 trial of the combination therapy has been
fully enrolled and the preliminary results were presented in 2016.
This novel combination is the subject of an issued US 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 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," "will," "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
ability to continue as a going concern, the 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.
General Contact
http://www.onconova.com/contact/
Investor Relations Contact
Lisa Sher, MBS Value Partners on behalf of Onconova Therapeutics
Lisa.Sher@mbsvalue.com / (212) 750-5800
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