Pint Pharma to
facilitate expansion of Phase 3 INSPIRE trial to Argentina, Chile, and
Brazil in preparation for future studies of oral rigosertib
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 that its commercial partner, Pint Pharma GmbH, will assist in
expanding access to clinical trials studying rigosertib, a novel and
targeted anti-cancer compound currently in a Phase 3 study for the
treatment of MDS, to several selected sites across South America. Pint
Pharma is a European-based pharmaceutical company focused on the
development, registration and commercialization of specialty-based
treatments for the Latin American market and has successfully
participated in clinical trials for hematological cancers.
“This
assistance will help make rigosertib available to cancer patients on a
fifth continent, following our ongoing clinical trials in North America,
Europe, Asia and Australia. We are delighted to partner with Pint
Pharma, which has a wide footprint in South and Central America, with
first-hand experience in running clinical trials for malignant
hematological disorders,” said Dr. Ramesh Kumar, CEO of Onconova
Therapeutics, Inc.
“We are excited to start
helping Onconova open new clinical sites in Latin America. We are
hopeful that Onconova will be able to start recruiting patients as soon
as possible to continue the development of IV and Oral Rigosertib,” said
David Munoz, Chief Executive Officer of Pint Pharma. He added,
“Rigosertib is highly complementary to our comprehensive hematology
oncology portfolio, and will further strengthen our mission to enable
the Latin American population with life-threatening conditions to live
better lives by providing early and efficient access to innovative
technologies.”
Dr. Steven Fruchtman, President
and Chief Medical Officer of Onconova, is working closely with Dr.
Valnei Canutti, General Manager, Brazil, and Chief Medical Officer of
Pint. Dr. Fruchtman commented, “Completion of the INSPIRE Trial and
expanding the potential utility of rigosertib for cancer patients are
our core objectives and we are delighted that our commercial partner
will assist us in recruiting patients in the INSPIRE trial. There is a
great medical need and interest to conduct studies in patients with
higher risk MDS in this geographical region.”
Dr.
Canutti added, “We are looking forward to working with Dr. Fruchtman on
this important initiative. My prior experience in MDS and our
connections with Key Opinion Leaders across this continent will be
greatly helpful as we collaborate with Onconova.”
About Pint Pharma
PINT
PHARMA INTERNATIONAL SA is a company registered under Swiss laws,
having its registered office at Route de Chenaux 9, 1091
Bourg-en-Levaux, Switzerland, and 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.
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. 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.
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.
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).
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 U.S. patent with earliest expiration in 2028.
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