Onconova Therapeutics to Present Update at the 2018 BIO Investor Forum in San Francisco
October 10 2018 - 8:30AM
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 (MDS), today announced that the Company
will be presenting at the BIO Investor Forum, October 17-18, 2018,
at the Westin St. Francis Hotel in San Francisco. Ramesh
Kumar, CEO, will present at the conference and meet with investors.
Presentation details |
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Date/Time: |
Thursday,
October 18th at 11:00 AM
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Venue: |
The Westin
St. Francis, San Francisco |
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Presenter: |
Ramesh
Kumar, CEO |
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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 is reported to block 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. Onconova has three product
candidates in the clinical stage and several pre-clinical
programs. Advanced clinical trials with 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 a randomized
Phase 3 international INSPIRE trial for patients with higher-risk
MDS, after failure of hypomethylating agent, or HMA,
therapy.
About INSPIRE
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 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 9 cycles over the course of one year after initiation and
with progression or failure to respond to 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, the
independent Data Monitoring 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 where the duration of treatment may
extend for years in lower risk MDS patients. This dosage form may
also support 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 1/2 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 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
Mark Guerin Onconova Therapeutics, Inc.
267-759-3680http://www.onconova.com/contact/
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