Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, with an initial focus on
myelodysplastic syndromes (MDS), today announced that it will be
presenting at three upcoming conferences:
Acute Leukemia Forum
China
May 31 – ShanghaiPresentation: Fri, May
31
Steven Fruchtman, MD, President & CEO
BIO International Forum,
Philadelphia June 3-6 – Philadelphia,
PAPresentation: Tues, June 4 3:15p
EDT Steven
Fruchtman, President & CEOWebcast:
http://www.veracast.com/webcasts/bio/internationalconvention2019/74119246905.cfmAvi
Oler, VP Corporate Development, will also attend and be available
to meet with interested parties
9th Annual LD Micro
Invitational
June 4-5 – Bel Air, CAPresentation: Tues, June 4 8:20a
PDT Mark Guerin,
CFO
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 an
initial focus on Myelodysplastic Syndromes (MDS). Rigosertib,
Onconova's lead candidate, is a proprietary Phase 3 small molecule,
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 Myelodysplastic
Syndromes
Myelodysplastic syndromes (MDS) are conditions
that can occur when the blood-forming cells in the bone marrow
become dysfunctional and thus produce an inadequate number of
circulating blood cells. It is frequently associated with the
presence of blasts or leukemic cells in the marrow. This leads
to low numbers of one or more types of circulating blood cells, and
to the need for blood transfusions. In MDS, some of the cells in
the bone marrow are abnormal (dysplastic) and may have genetic
abnormalities associated with them. Different cell types can
be affected, although the most common finding in MDS is a shortage
of red blood cells (anemia). Patients with higher-risk MDS may
progress to the development of acute leukemia.
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule. A key publication demonstrated
rigosertib’s ability to block cellular signaling by targeting RAS
effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule
RAS-Mimetic Disrupts RAS Association with Effector Proteins to
Block Signaling." Cell 165, 643). Onconova is currently in the
clinic with oral and IV rigosertib, including single agent IV
rigosertib in second-line high-risk MDS patients (pivotal Phase 3
INSPIRE trial) and oral rigosertib plus azacitidine in first-line
high-risk MDS patients (Phase 2). Patents covering oral and
injectable rigosertib have been issued in the U.S. and are expected
to provide coverage until at least 2037.
About IV Rigosertib
The intravenous form of rigosertib has been
studied in Phase 1, 2, and 3 clinical trials involving more than
1000 patients, and is currently being evaluated in a randomized
Phase 3 international INSPIRE trial for patients with high-risk MDS
(HR-MDS), after failure of hypomethylating agent, or HMA,
therapy.
About the INSPIRE Phase 3 Clinical
Trial
The INternational
Study of Phase 3
IV RigosErtib,
or INSPIRE, was finalized following guidance
received from the U.S. Food and Drug Administration and European
Medicines Agency. INSPIRE is a global 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 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. An interim analysis in early
2018 demonstrated a promising survival signal in the
intent-to-treat population as reviewed by the Independent Data
Monitoring Committee. The 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, over 400
patients have been studied with the oral formulation of rigosertib.
Combination therapy of oral rigosertib with azacitidine, the
standard of care in HR-MDS, has also been studied. 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 efficacy and safety data was
presented at The American Society of Hematology Annual Meeting in
December 2018. A pivotal Phase 3 study design is under review by
the FDA, and the Special Protocol Assessment is expected to
conclude in the 1H of 2019.
About CDK Inhibitors
A key feature of cancer cells is their ability
to rapidly multiply. CDK inhibitors are thought to disrupt this
process by blocking the activity of enzymes known as CDKs. In
particular, CDK4 and CDK6 are considered potential anticancer drug
targets, due to their role regulating cell cycle progression at the
G1 restriction point. CDK inhibitors have the potential and health
authority approval in combination with an aromatase inhibitor to
treat one of the most common types of breast cancer known as
hormone receptor-positive metastatic breast cancer, in which the
cancer cells express hormone receptors. ON 123300 was found to be
as active as commercially approved CDK 4 and 6 inhibitors but with
extra anti-tumor metastasis activity in a preclinical Rb + ve
xenograft model. Moreover, the molecule may have the potential
advantage of reduced neutropenia in preclinical models.
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 its
products, its collaboration with HanX, 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" 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
Avi Oler Onconova Therapeutics, Inc. 267-759-3680
http://www.onconova.com/contact/
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