Onconova Therapeutics Announces Issuance of a New U.S. Patent for Rigosertib
October 17 2018 - 8:30AM
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 the United
States Patent and Trademark Office issued a new patent protecting
the company’s lead product candidate, Rigosertib. U.S. patent
10,098,862 “Formulations with enhanced stability and
bioavailability for administration of (E)-2, 6-Dialkoxystyryl
4-Substituted Benzyl Sulfones” describes novel compositions
directed towards improving stability and enhancing bioavailability
of Rigosertib. The issued patent claims novel formulations
for oral and parenteral administration and oral dosing regimens of
Rigosertib for the treatment of cancer and proliferative disorders.
“Rigosertib is well protected by issued US and
foreign patents as well as by Orphan Designation in the U.S.,
Europe, and Japan. We remain focused on our broader IP strategy
that provides additional barriers to entry and expanded
geographical coverage for our lead product candidate, which is in
advanced clinical trials for unmet medical needs of patients with
Myelodysplastic Syndromes,” commented, Ramesh Kumar, Chief
Executive Officer of Onconova. “Ensuring multi-faceted intellectual
property protection around Rigosertib helps enhance the potential
value of this innovative program.”
U.S. patent 10,098,862 complements and adds to
coverage provided by previously issued Composition of Matter patent
U.S. 7,598,232 and its international counterpart patents and patent
applications, including Rigosertib drug combination patents. While
previous patents cover compositions, methods, formulations and
other aspects of utility, the new patent provides additional
coverage related to an oral dosing regimen of Rigosertib. The novel
formulation patent was filed in 2017 as a PCT application globally
and as National Phase applications in the U.S. and in Non-PCT
countries including Taiwan and various countries in Latin
America.
The named inventor of the patented technology is
Dr. Manoj Maniar, Senior Vice President of Product Development for
Onconova. The patent was filed by and is assigned to the
Company.
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 is reported to block 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. 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
and with progression or failure to respond to 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 where the duration of treatment may
extend for years in lower risk MDS patients. 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.
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,” “is being sought,” 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, the need for additional financing, the
success and timing of Onconova's clinical trials and regulatory
approval of protocols, 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 Contact
Mark Guerin Onconova Therapeutics, Inc.
267-759-3680http://www.onconova.com/contact/
Onconova Therapeutics (NASDAQ:ONTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Onconova Therapeutics (NASDAQ:ONTX)
Historical Stock Chart
From Sep 2023 to Sep 2024