Onconova Therapeutics, Inc. (Nasdaq:ONTX), a Phase 3-stage
biopharmaceutical company focused on discovering and developing
small molecule drug candidates to treat cancer, today announced
that it is moving forward with its Phase 3 INSPIRE pivotal trial
following the interim analysis, consistent with the DMC’s
recommendation. The DMC recommended continuation of the trial with
a one-time expansion in enrollment, using a pre-planned sample size
re-estimation, consistent with the Statistical Analysis Plan (SAP).
The INSPIRE pivotal trial is studying intravenously-administered
(IV) rigosertib in patients with higher-risk myelodysplastic
syndromes (MDS) who have progressed on, failed to respond to, or
relapsed after prior hypomethylating agent (HMA) therapy. The
Company remains blinded to the interim analysis results.
Guillermo Garcia-Manero, M.D, Professor and Chief of the MDS
Section at the MD Anderson Cancer Center, a lead investigator on
the INSPIRE study, commented, “Choices are very limited for higher
risk MDS patients after failure of HMA therapy and no second-line
therapy has ever been approved by the Health Authorities for these
patients. These patients have a very short life-span and there is a
tremendous unmet medical need. We remain highly supportive of
Onconova’s efforts. After the interim analysis, continuation of the
INSPIRE study is encouraging for patients.”
The SAP for the INSPIRE trial featured an adaptive trial design,
permitting several options following the interim analysis, which
included continuation of the trial as planned, discontinuation of
the trial for futility, trial expansion using pre-planned sample
size re-estimation, and trial continuation for only the pre-defined
treatment subgroup of patients classified as VHR based on the
Revised International Prognostic Scoring System (IPSS-R).
The expanded INSPIRE study will continue to enroll eligible
patients based on the current trial design of the overall ITT
population and will increase enrollment by adding 135 patients to
the original target to reach a total enrollment of 360 patients,
with the aim of increasing the power of the trial. Due to the
adaptive trial design and the DMC’s assessment, the INSPIRE trial
will continue to analyze both the ITT and the VHR population for
the primary endpoint of overall survival. The design of the trial
with the expanded study enrollment will be identical to the current
study design and will include the analysis of the overall survival
endpoint in the ITT and the pre-specified VHR subgroup.
Steve Fruchtman, M.D., Chief Medical Officer of Onconova, added,
“With no FDA approved therapies for many patients with higher-risk
MDS who are refractory to HMAs, we are encouraged by these results
and pleased to be at the forefront of advances in this treatment
landscape. The DMC’s recommendation based on the pre-planned
interim analysis includes the expansion of the INSPIRE trial and
retains the analysis of survival in both the ITT and the VHR
pre-defined subgroups. Patients with MDS who are refractory to HMAs
have the highest unmet medical need due to an extremely poor
prognosis following failure of HMA therapy. We look forward to
completing enrollment and for the opportunity to analyze overall
survival in the higher-risk MDS patients who have failed prior HMA
therapy.”
Currently, the INSPIRE study is active at approximately 175
trial sites in 22 countries across four continents, and has
enrolled more than 170 patients. In Japan, patients have been
enrolled to this study by SymBio Pharmaceuticals, our collaboration
partner for Japan and Korea. Onconova believes that this trial is
the most advanced study for a new therapeutic agent in this
indication, and there are no FDA approved therapies specifically
for MDS patients after failure of front-line HMAs.
The Company will host a conference call today, January
17th at 8:30 a.m. Eastern Time to discuss the interim results and
answer any questions. 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: 8899928.
The call will also be webcast live. Please
click here to access the
webcast.
A replay will be available at this link until April 30,
2018.
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 we
believe 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 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 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 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, 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 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 Therapeutics, Inc.'s expectations regarding the
INSPIRE Trial. 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
Katja Buhrer, Affinity Growth Advisors on behalf of Onconova
Therapeutics
Katja.Buhrer@affinitygrowth.com / (212) 661-7004
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