Source: Onconova Therapeutics, Inc. 1/15/19
- Executive succession plan maintains momentum of recent significant advances
- Onconova well-positioned to deliver key milestones in 2019 for both intravenous and oral rigosertib, as well as other pipeline products
"Steve
is the right leader for Onconova at this time. He has been instrumental
to the Company’s progress thus far and his proven track record in drug
development will continue to serve the Company well as it advances the
Phase 3-stage rigosertib programs toward approval and commercialization.
The Board thanks Ramesh for his leadership and contributions to
Onconova, and for positioning Onconova to reach critical upcoming
milestones. We view Steve, and the recently expanded executive team that
he has assembled, as poised to achieve clinical progress and business
development objectives,” said Michael Hoffman, Chairman of the Onconova
Board of Directors.
Dr. Fruchtman has
extensive industry experience in clinical research in MDS, hematologic
malignancies, and solid tumors. He served with increasing leadership
responsibilities at Ortho Biotech, Novartis, and biotechnology companies
leading to successful clinical trial completion and regulatory
approvals for a number of new chemical entities in various malignancies.
Prior to his transition to industry, Steve served as the Director of
the Myeloproliferative Disorder Program at The Mount Sinai Hospital in
New York City, a Center of Excellence, and established the Stem Cell
Transplant Program there. His commitment to the areas of
hematology/oncology and myeloproliferative disorders is exemplified by
his service as an external reviewer for prestigious journals such as the
New England Journal of Medicine, Mayo Clinic Proceedings, Experimental Hematology, and others.
He received his Bachelor of Arts with Honors from Cornell University,
and his M.D. from New York Medical College. He was recently named to the
Board of The Bone Marrow Foundation. Dr. Fruchtman commented, “I am
very grateful to the Board for this honor. I thank Ramesh for his
mentorship during my tenure as President and Chief Medical Officer. My
colleagues at Onconova and I are focused on achieving our milestones.
The global INSPIRE trial for rigosertib in MDS has the potential to
offer a novel treatment option for these patients. We are very excited
about the anticipated full enrollment of the INSPIRE trial in the second
half of 2019, the advancement to Phase 3 of the oral rigosertib
combination trial, and the studies of rigosertib in pediatric
RASopathies and other unmet medical needs. I firmly believe that
rigosertib has the potential to support multiple indications in
different areas of oncology. In addition, our innovative CDK 4/6
inhibitor, ON 123300, is in advanced pre-IND stage, and is expected to
enter the clinic during the first half of the year. This vision presents
opportunities to enhance the value of the Company in the coming years.”
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 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.
About IV Rigosertib
Intravenous
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 Higher Risk-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 study 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 combination therapy modalities. To
date, more than 400 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,
chemotherapy or radiotherapy 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.
The results of an expanded Phase 2 trial of oral rigosertib combination
therapy with azacitidine were presented at the 2018 ASH Annual
Meeting. Patents covering oral and injectable rigosertib have been
issued in the US, and are expected to provide coverage until at least
2037.
