Onconova Therapeutics, Inc. (Nasdaq:ONTX), a Phase 3 stage
biopharmaceutical company focused on discovering and developing
small molecule drug candidates to treat cancer, with a primary
focus on Myelodysplastic Syndromes (MDS), has presented data on a
new formulation of rigosertib with enhanced bioavailability, as
well as pre-clinical data on metabolism and bioavailability for a
first-in-class dual inhibitor of CDK4/6 + ARK5. Three posters were
presented at the American Association of Pharmaceutical Scientists
(AAPS) Annual Meeting and Exposition, the world’s largest
pharmaceutical sciences meeting, during November 14-15, 2017.
Enhancement of Oral Absorption of
RigosertibPoster #: T2070
Abstract #: AM-17-1064Date:
November 14, 2017Time: 10:00 – 11:00 am PST (1:00
– 2:00 pm EST)Location: San Diego Convention
Center, CaliforniaRen, C.; Fox, D.; Maniar, M.
Oral Rigosertib in combination with azacitidine is currently
being evaluated in a Phase 2 clinical trial in patients with
higher-risk MDS. The new formulation, which is encapsulated in an
enteric polymer, enhanced bioavailability in animal studies by over
75% compared to Onconova’s current soft gelatin capsule
formulation, which shows good bioavailability of ~35% in MDS
patients.
"The improvement in bioavailability resulting from our extensive
formulation development efforts far exceeded our expectations, and
we look forward to evaluating the bioavailability of the new dosage
form in humans,” said Dr. Manoj Maniar, Senior Vice President of
Product Development, Onconova.
Liver Microsomal Stability of ON 123300 and
Identification of MetabolitesPoster #:
W4103 Abstract #: AM-17-3113
Date: November 15, 2017Time:
12:00 – 1:00 pm PST (3:00 – 4:00 pm EST)Location:
San Diego Convention Center, CaliforniaRen, C.; Maniar, M.
Effect of Formulation on Pharmacokinetics of ON 123300
in Rats Following Oral AdministrationPoster
#: W4101Abstract #: AM-17-3086
Date: November 15, 2017Time:
12:00 to 1:00 pm PST (3:00 – 4:00 pm EST)Location:
San Diego Convention Center, CaliforniaMudunuru, J.; Ren, C.; Taft,
D.; Maniar, M.
"Identifying animal species that show similar pharmacology and
pharmacokinetics to that of humans is critical to understanding the
potential long term toxicity of ON 123300, a third-generation
potent CDK4/6 inhibitor that also inhibits ARK5 with low nanomolar
potency. In addition, our improved understanding of the mechanism
of metabolism and the identification of metabolites has advanced
our selection of the relevant species for IND enabling
toxicological studies. We are also pleased to report that our
formulation development efforts resulted in a two to three fold
increase in the bioavailability of ON 123300.”
“Given the limitations of second-generation compounds that
require a combination treatment for therapeutic use, we are excited
to advance our next-generation CDK4/6 inhibitors such as ON 123300
toward IND. We are also enthused by the potential of ON 123300 to
act as a single agent, dual inhibitor of CDK 4/6 + ARK 5, which is
suitable for indications that may not be amenable to
Palbociclib-like compounds,” concluded Dr. Maniar.
A full copy of the AAPS posters can be accessed by visiting
"Scientific Presentations" in the Investors and Media section of
Onconova's website.
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. The advanced clinical trial with
the Company’s lead compound, rigosertib, is 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 the randomized Phase 3 international
INSPIRE trial for patients with higher-risk (HR) MDS, after failure
of hypomethylating agent, or HMA, therapy.
About INSPIRE
The INternational Study
of Phase
III IV RigosErtib,
or INSPIRE, trial design 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
of HMA treatment. This time frame optimizes the opportunity
to respond to treatment with an HMA prior to declaring treatment
failure, as per the National Comprehensive Cancer Network (NCCN)
Guidelines. The trial will enroll approximately 225 patients
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 and an interim analysis is anticipated. 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 also supports 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 US 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 future events or Onconova Therapeutics, Inc.'s future
operations, clinical development of Onconova's product candidates
and presentation of data with respect thereto, regulatory
approvals, expectations regarding the sufficiency of Onconova's
cash and other resources to fund operating expenses and capital
expenditures, Onconova's anticipated milestones and future
expectations and plans and prospects. 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. Onconova has attempted to identify
forward-looking statements by terminology including "believes,"
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should," "approximately" or other words
that convey uncertainty of future events or outcomes. 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 and current plans and future needs to scale back
operations if adequate financing is not obtained, 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
Contacthttp://www.onconova.com/contact/
Investor Relations Contact
Katja Buhrer, Affinity Growth Advisors on behalf
of Onconova Therapeutics
Katja.buhrer@affinitygrowth.com / (212) 661-7004
Source: Onconova Therapeutics, Inc.
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