Source: Onconova Therapeutics, Inc. 10/21/18
- Granted claims cover both oral and injectable formulations of Rigosertib
- Newly issued US patent 10,098,862 extends protection for Rigosertib into 2037
- Equivalent coverage is being sought worldwide and, if granted, will expand intellectual property protection for Rigosertib in additional countries
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.
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