Onconova Therapeutics Announces Presentation at the 23rd Congress of the European Hematology Association
June 07 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 a presentation at
the 23rd Congress of the European Hematology Association being held
June 14-17, 2018 in Stockholm, Sweden. Dr. Steven Fruchtman,
Onconova’s Chief Medical Officer and Senior VP, Research &
Development, will be attending the conference.
DETAILS OF
THE PRESENTATION: |
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Title: |
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ASSOCIATION
OF EMERGENT PTPN11 MUTATIONS WITH CLINICAL RESISTANCE TO THE
COMBINATION OFAZACITIDINE AND RIGOSERTIB IN PATIENTS WITH
HIGHER-RISK MYELODYSPLASTIC SYNDROME |
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Format: |
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Poster
presentation |
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Date/Time: |
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Friday,
June 15 from 5:30p – 7:00p |
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Presenter: |
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Lewis
Silverman, M.D., ICAHN School of Medicine, Mount Sinai, New
York |
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Abstract: |
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PF489 |
A copy of the poster and oral presentation will be available by
visiting "Scientific Presentations" in the Investors section of
Onconova's website immediately following the event.
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. 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 RigosertibThe 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 INSPIREThe 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 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. 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 RigosertibThe 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, 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 US patent with earliest
expiration in 2028.
Forward Looking StatementsSome 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 Therapeutics, Inc.'s expectations regarding the INSPIRE
Trial and the transactions contemplated by the licensing agreement.
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/
Mark GuerinOnconova Therapeutics, Inc.267 759 3680
Onconova Therapeutics (NASDAQ:ONTX)
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