Onconova Announces Multiple Presentations at the 22nd Congress of the European Hematology Association
May 22 2017 - 8:30AM
Clinical and Non-clinical Data Evaluating Oral
Rigosertib Plus Azacitidine Combination Therapy
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 multiple
presentations discussing clinical and non-clinical studies relating
to their oral rigosertib plus azacitidine combination therapy for
which a Phase 3 trial is being designed. In addition, SymBio,
Onconova’s partner in Japan and Korea, will present Phase 1 data
evaluating intravenous rigosertib in Japanese patients with
recurrent/relapsed or refractory Myelodysplastic Syndromes.
DETAILS OF THE PRESENTATIONS:
Combination Therapy with Rigosertib Plus
Azacitidine |
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Oral Rigosertib Combined With Azacitidine in Patients with
Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS):
Effects in Treatment of Naive and Relapsed/Refractory
Patients |
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Format: |
Oral presentation |
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Date: |
June 24, 2017 |
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Presenter: |
Shyamala Navada, M.D.,
Assistant Professor, Mount Sinai School of Medicine |
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Abstract: |
S488 |
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Rigosertib Combined with Azacitidine Epigenetically
Modulates Chromatin and Hematopoietic Stem Cell Populations in the
Myelodysplastic Syndromes (MDS) |
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Author: |
Pratima Chaurasia,
Ph.D., Assistant Clinical Professor, Mount Sinai School of
Medicine |
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Shyamala C. Navada,
M.D., Assistant Professor, Mount Sinai School of Medicine |
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Abstract: |
E1170 |
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Oral Rigosertib as a Single Agent |
|
A
Multicenter, Open-label, Phase 1 Cinical Study: Safety, Efficacy,
and Pharmacokinetics of Oral Rigosertib in Japanese Patients with
Recurrent/Relapsed or Refractory Myelodysplastic
Syndromes |
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Format: |
E Poster
Presentation |
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Author: |
Kenichi Ishizawa, M.D.,
Ph.D. |
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Abstract: |
E1199 |
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Another
abstract of Phase 1 Data Demonstrating Intravenous Rigosertib as a
Single Agent from SymBio collaborators will be published as an
abstract only: |
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Safety, Efficacy and Pharmacokinetics of Intravenous
Rigosertib in Japanese Patients with Recurrent/Relapsed or
Refractory Myelodysplastic Syndromes (MDS): A Multicenter,
Open-label, Phase 1 Study |
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Format: |
Publication only |
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Author: |
Michinori Ogura, M.D.,
Ph.D. |
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Abstract: |
PB1919 |
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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 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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