- The INSPIRE Trial enters the final stage of enrollment after surpassing 90% of the required number of randomized patients in November 2019
- Pint Pharma Facilitates Opening of Phase 3 INSPIRE Trial in Brazil
- Topline Data Expected in First Half 2020
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.”
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.
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