Source: Onconova Therapeutics, Inc.
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 the promotion of Dr.
Steven M. Fruchtman. In his new role as President, Dr. Fruchtman will
have oversight over the entire product portfolio, as well as a key role
in all other areas of the Company. He will continue to maintain the
responsibilities of Chief Medical Officer until a replacement is hired
to assume that role. Dr. Fruchtman will continue to report to Dr. Ramesh
Kumar, co-founder and Chief Executive Officer of the Company.
Dr.
Fruchtman joined Onconova as Chief Medical Officer (CMO) and Senior
Vice President, Research and Development, in January 2015. He is a board
certified hematologist with extensive industry experience in clinical
research for myelodysplastic syndromes, hematologic malignancies and
solid tumors. Prior to his transition to industry, Dr. Fruchtman served
as the Director of the Myeloproliferative Disorder Program at Mt. Sinai
Hospital in New York City and established the Stem Cell Transplant
Program there. He has served with increasing responsibilities at Ortho
Biotech, Novartis, and biotechnology companies Allos, Spectrum, and
Syndax, leading to Health Authority approvals for a number of new
chemical entities in various malignancies. His commitment to the areas
of hematology/oncology and myeloproliferative disorders is exemplified
by his service as an external reviewer for the New England Journal of Medicine, Mayo Clinic Proceedings, Experimental Hematology, European Journal of Haematology, Leukemia, and his role as a member of the editorial board of The Mount Sinai Journal of Medicine.
Dr. Fruchtman is an author of more than 170 lectures, presentations,
books, and chapters. 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 located in
NYC.
“Steve has an enviable track record of successful
development and approval of several new drugs for the unmet needs of
cancer patients. His background as a practicing hematologist/oncologist,
combined with his research and development acumen and experience,
position him very well to lead the development of our innovative late
stage portfolio of small molecule products for MDS and other cancers,”
said Dr. Kumar.
“I am honored by this promotion and to be
entrusted with increased responsibility,” said Dr. Fruchtman. “We have
made significant progress on the INSPIRE TRIAL in higher-risk MDS since
announcing the results of a pre-planned interim analysis in January. We
are also advancing the design of a pivotal combination trial of oral
rigosertib and azacitidine by optimizing the dosage. These trials have
set a solid foundation in the studies of rigosertib in patients with
MDS. While focused on advancing Rigosertib towards regulatory approval
for MDS, we also recognize the many additional opportunities and avenues
open to us. In the era of genomic medicine, we plan to investigate
other indications where mutated and overexpressed pathways could be
targeted by our novel compounds. These are exciting times for Onconova.”
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
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.
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 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).
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 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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