Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage
biopharmaceutical company discovering and developing novel products
to treat cancer, with an initial focus on myelodysplastic syndromes
(MDS), and Pint Pharma, a European-based pharmaceutical company
focused on the development, registration and commercialization of
specialty-based treatments for the Latin American market, today
announced the receipt of approval from the Brazilian Health
authority to initiate the INSPIRE Trial in Brazil with intravenous
rigosertib in Higher-Risk MDS (HR-MDS). In November 2019
enrollment in the INSPIRE Trial surpassed 90% percent of the
required enrollment, and the Company continues to anticipate
reporting topline data in the first half of 2020, following full
enrollment and reaching the number of required survival events.
“As we enter the final stage of enrollment of
the INSPIRE Trial, we thank our corporate partner Pint Pharma for
their collaboration in opening the study in Brazil,” said Dr.
Steven Fruchtman, President and CEO of Onconova Therapeutics, Inc.
“The INSPIRE Trial surpassed 90% percent of the required enrollment
in November 2019 and we expect the addition of up to 16 clinical
trial sites in Brazil will provide further momentum to our
anticipated reporting of topline data in the first half of 2020,
following full enrollment and reaching the number of required
survival events.”
“We are excited to collaborate with Onconova in
opening new clinical sites and look forward to the recruitment of
eligible patients for the INSPIRE Trial in Brazil,” said David
Munoz, Chief Executive Officer of Pint Pharma. He added, “We are
also pleased that local physicians will gain invaluable experience
with rigosertib by their participation on the INSPIRE Trial.”
Dr. Ric Woodman, Chief Medical Officer of
Onconova, is working closely with Dr. Valnei Canutti, Chief
Scientific Officer of Pint. Dr. Woodman commented, “There is a
great unmet medical need and interest to conduct studies in
patients with HR-MDS in this geographical region. I look forward to
a productive collaboration with Pint Pharma and working with Dr.
Canutti, an expert in conducting trials in Brazil as well as
an expert in MDS.”
Dr. Canutti added, “We anticipate meaningful
contributions from Brazil to accrual to the INSPIRE Trial and are
excited about receiving health authority approval to initiate
INSPIRE in Brazil. There are significant numbers of patients
with HR-MDS in Brazil with no approved approach following
failure of the standard of care azacitidine. We at Pint, in
collaboration with our partner Onconova, look forward to Brazil’s
contributions to complete accrual to this important pivotal global
trial.”
About Pint Pharma
Pint Pharma is devoted to the development,
registration, and commercialization of specialty-based treatments.
Pint Pharma benefits from leaders with extensive experience in the
pharmaceutical sector and who are based strategically throughout
Latin America and Europe. Pint Pharma has a long track record of
developing strong relationships with global pharmaceutical and
healthcare companies. Pint Pharma strives to be the first Pan-Latin
American provider of innovative and high value-added treatments
within Rare Diseases, Specialty Care, and Oncology.
About Onconova Therapeutics,
Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, with an initial focus on
Myelodysplastic Syndromes (MDS). 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. 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.
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
http://www.onconova.com.
About Myelodysplastic
Syndromes
Myelodysplastic syndromes (MDS) are conditions
that can occur when the blood-forming cells in the bone marrow
become dysfunctional and thus produce an inadequate number of
circulating blood cells. It is frequently associated with the
presence of blasts or leukemic cells in the marrow. This
leads to low numbers of one or more types of circulating blood
cells, and to the need for blood transfusions. In MDS, some of the
cells in the bone marrow are abnormal (dysplastic) and may have
genetic abnormalities associated with them. Different cell
types can be affected, although the most common finding in MDS is a
shortage of red blood cells (anemia). Patients with
higher-risk MDS may progress to the development of acute
leukemia.
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule. A key publication in a
preclinical model demonstrated 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). Onconova is currently in the clinical development stage with
oral and IV rigosertib, including clinical trials studying single
agent IV rigosertib in second-line higher-risk MDS patients
(pivotal Phase 3 INSPIRE trial) and oral rigosertib plus
azacitidine in first-line and refractory higher-risk MDS patients
(Phase 2). Patents covering oral and injectable rigosertib
have been issued in the US and are expected to provide coverage
until at least 2037.
About the INSPIRE Phase 3 Clinical
Trial
The 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 is 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
optimizes the opportunity to respond to treatment with an HMA prior
to declaring treatment failure, as per NCCN Guidelines.
Patients are 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 is
overall survival. The trial continued beyond the
pre-specified interim analysis and is nearing its conclusion. 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 IV Rigosertib
The intravenous form of rigosertib has been
studied in Phase 1, 2, and 3 clinical trials involving more than
1000 patients, and is currently being evaluated in a randomized
Phase 3 international INSPIRE trial for patients with
HR-MDS after failure of HMA therapy.
About Oral Rigosertib
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. Combination therapy of oral
rigosertib with azacitidine, the standard of care in HR-MDS, has
also been studied. 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 efficacy and
safety data was presented at The American Society of Hematology
(ASH) Annual Meeting in December 2019.
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, maintain its Nasdaq listing, the need for additional
financing, the success and timing of Onconova's clinical trials and
regulatory approval of protocols, our collaborations, 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 Contacts
Avi OlerOnconova Therapeutics, Inc.
267-759-3680http://www.onconova.com/contact/
Pint Pharma GmbHWipplingerstrasse 34 Top 112 – 119 Vienna
(Austria)Central line: +43 1 259 47 35www.pint-pharma.comAlejandra
PedrazaHead of Business & Corporate DevelopmentOffice: +43 1
259 47 35 66Email: alejandra.pedraza@pint-pharma.com
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