Onconova Therapeutics, Inc. (NASDAQ: ONTX) a biopharmaceutical
company focused on discovering and developing novel products to
treat cancer, today announced that INSPIRE, the company’s pivotal
Phase 3 study assessing the efficacy and safety of IV rigosertib in
higher-risk MDS (HR-MDS) patients, did not meet its primary
endpoint of improved survival.
“Onconova would like to thank the MDS community
for its participation in the INSPIRE trial. We report these results
with great disappointment, and we remain deeply indebted to every
patient, physician, and family member involved in the study,” said
Steven M. Fruchtman, M.D., President and Chief Executive Officer.
“Onconova is fortunate to have built a product pipeline that
includes multiple promising agents, including oral rigosertib and
ON 123300. Both compounds target meaningful cancer pathways, and we
look forward to further efforts with these programs. The Company
will review pipeline and in-licensing opportunities both internally
and with external advisors.”
The primary endpoint of the trial was overall
survival, comparing IV rigosertib plus best supportive care to
physician's choice (PC) plus best supportive care in patients who
had progressed on, failed to respond to, or relapsed after previous
treatment with a hypomethylating agent (HMA) within nine cycles
over the course of one year after initiation of HMA treatment. A
pre-specified analysis in the very high risk (VHR-MDS) patient
subgroup was also conducted.
Results of INSPIRE demonstrated that in the
intent-to-treat analysis patients randomized to IV rigosertib
achieved overall survival of 6.4 months, versus 6.3 months for PC
(p=0.33) in the overall HR-MDS population. Overall survival in the
pre-specified VHR-MDS subgroup of patients was also not
significantly different between the two study arms. There was
an increase in overall survival in the PC arm post-interim analysis
that was unexpected. The Company is conducting additional
analyses.
Safety analysis indicates that IV rigosertib was
generally well tolerated, with reported adverse events similar to
those observed in previous clinical studies with IV rigosertib in
MDS. Serious adverse events (SAEs) were uncommon, with a similar
profile of SAEs in both study arms.
“While the INSPIRE data readout in HR-MDS is a
disappointment, as a RAS pathway inhibitor oral rigosertib could
address a number of oncology settings outside of hematology,” said
Richard C. Woodman, M.D., Chief Medical Officer of Onconova. “We
plan to take learnings from genomic analyses of the INSPIRE trial
to inform the future development of rigosertib. We also look
forward to the continued expansion of the investigator-initiated
study program with oral rigosertib beyond the ongoing Phase 1/2a
study in KRAS+ lung adenocarcinoma into additional solid tumors.
Our novel CDK4/6 + ARK5 inhibitor, ON 123300, could also represent
a meaningful advance over existing products.”
The Company will host a conference call today,
August 24, 2020, at 8:30 a.m. Eastern Time. Interested parties who
wish to participate in the conference call may do so by dialing
(855) 428-5741 for domestic callers and (210) 229-8823 for
international callers, and using conference ID 8087044.
To facilitate an on-time conference call start,
Onconova recommends that participants dial in 15 minutes before the
8:30 a.m. ET start time.
Those interested in listening to the conference
call via the internet may do so by visiting the investors and media
page on the company's website at www.onconova.com and clicking on
the webcast link. In addition to the live webcast, a replay will be
available on the Onconova website for 90 days following the
call.
About Onconova Therapeutics,
Inc.Onconova Therapeutics is a biopharmaceutical company
focused on discovering and developing novel drugs to treat cancer.
Onconova has a pipeline of proprietary targeted agents designed to
work against specific cellular pathways that are important in
cancer cells. Clinical trials with the Company’s compound
rigosertib are aimed at what the Company believes are unmet medical
needs of patients with cancer. Onconova has conducted trials with
two other research compounds, and has a pre-clinical program with a
CDK4/6 and ARK5 inhibitor, ON 123300.
For more information, please visit
https://www.onconova.com.
About RigosertibRigosertib,
Onconova’s lead candidate, is a proprietary small molecule. A key
publication in a preclinical model reported rigosertib’s ability to
block cellular signaling by targeting RAS effector pathways
(Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic
Disrupts RAS Association with Effector Proteins to Block
Signaling." Cell 165, 643). Preclinical work with rigosertib is
underway in COVID-19. Patents covering oral and injectable
rigosertib have been issued in the US and are expected to provide
coverage until at least 2037.
The oral form of rigosertib was developed to
provide a potentially more convenient dosage form for use where the
duration of treatment may extend to multiple years. This dosage
form may also support combination therapy modalities. To date, over
400 patients have been dosed with the oral formulation of
rigosertib in clinical trials. In addition, an
investigator-initiated Phase 1/2a study in KRAS+ lung
adenocarcinoma is ongoing.
About INSPIREThe clinical trial
INternational Study of
Phase 3 IV
RigosErtib, or INSPIRE, was
finalized following guidance received from the U.S. Food and Drug
Administration and European Medicines Agency. INSPIRE was a global,
multi-center, randomized, controlled study to assess the efficacy
and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients
who had progressed on, failed to respond to, or relapsed after
previous treatment with a hypomethylating agent (HMA) within nine
cycles over the course of one year after initiation of HMA
treatment. This time frame for the opportunity to respond to
treatment with an HMA prior to declaring treatment failure is per
the NCCN Guidelines. Patients were randomized at a 2:1 ratio into
two study arms: IV rigosertib plus best supportive care versus
physician's choice plus best supportive care. The primary endpoint
of INSPIRE was 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).
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 expectations regarding its clinical development plans and
patents. 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 the success and timing
of Onconova's clinical trials and regulatory approval of protocols,
Onconova’s ability to continue as a going concern, the need for
additional financing, our collaborations including the effective
termination of the HanX license and securities purchase agreements
and plans for partnering certain territories, 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.
Press release contact
information
Company Contact:
Avi OlerOnconova Therapeutics, Inc.267-759-3680
ir@onconova.ushttps://www.onconova.com/contact/
MediaDavid Schull, Russo Partners LLC: (212)
845-4271Nic Johnson, Russo Partners LLC: (212) 845-4242
InvestorsJan Medina, CFA, Russo Partners LLC:
(646) 942-5632
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