Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a Phase
3-stage biopharmaceutical company discovering and developing novel
products to treat cancer, with an initial focus on myelodysplastic
syndromes (MDS), and Inceptua Medicines Access (a business unit of
the Inceptua Group), a global pharmaceutical company and service
partner, today announced that they have entered into a
collaboration to make available intravenous rigosertib via a
Pre-approval Access Program in selected countries around the world.
Pre-approval Access Programs (also known as
expanded access, early access, compassionate use, named patient
supply) are regulatory-compliant processes permitting experimental
agents in development to be made available upon the request of a
physician or a patient for appropriate patients for whom no
alternative treatment option exists in their country. Rigosertib is
a small molecule that inhibits cellular signaling in cancer cells
by acting as a RAS mimetic. Current clinical development of
rigosertib is centered upon the therapeutic management of MDS, a
heterogeneous group of bone marrow disorders characterized by
ineffective hematopoiesis that often develop into acute myeloid
leukemia (AML). Rigosertib, in its intravenous formulation, is
currently in Phase 3 clinical development for the treatment of
higher-risk MDS.
The rigosertib Pre-approval Access Program is
expected to launch in first half of 2020 and will allow Inceptua to
supply intravenous rigosertib within designated countries,
primarily and initially concentrated in selected countries in
Europe, in response to physician requests for patients with
higher-risk MDS who have exhausted all available treatment options,
and are not eligible for or have no access to the INSPIRE study.
Under the terms of this agreement, Inceptua will support Onconova
through the pre-approval provision of intravenous rigosertib
initially into a number of countries including: Australia, Denmark,
Finland, France, Ireland, Italy, the Netherlands, Portugal, South
Africa, Spain, and the UK.
“Inceptua Medicines Access is delighted to be
selected as Onconova’s partner for the Pre-approval Access Program
for rigosertib. Higher-risk MDS is a disease with significant unmet
need, and we are pleased to be able to support healthcare
professionals seeking access to rigosertib, ahead of its commercial
launch,” said Mark Corbett, EVP, Inceptua Medicines Access.
Steven M. Fruchtman, M.D., President and Chief
Executive Officer of Onconova, said, “The rigosertib Pre-approval
Access Program is a key strategic initiative for Onconova. We are
pleased that intravenous rigosertib will be made compliantly
available to suitable patients with higher-risk MDS through
their physicians in designated countries. The program will run
alongside our ongoing Phase 3 INSPIRE Trial, and is expected to
continue until commercial launch in such countries. We are pleased
to work with Inceptua, given their strong record of administering
such programs successfully.”
Please note: Inceptua can only
respond to unsolicited requests from bona fide healthcare
professionals. Healthcare professionals can obtain information
about the rigosertib Pre-approval Access Program by contacting
Inceptua either by telephone +44 20 3910 7600 or by email:
Access@inceptua.com.
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). 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. 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.
Onconova has conducted trials with two other research compounds and
has a pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON
123300.
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 in a
preclinical model 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 clinical development stage with
oral and IV rigosertib, including clinical trials studying single
agent IV rigosertib in second-line higher-risk MDS patients
(pivotal Phase 3 INSPIRE trial) and oral rigosertib plus
azacitidine in first-line and refractory higher-risk MDS patients
(Phase 2). Patents covering oral and injectable rigosertib have
been issued in the US and are expected to provide coverage until at
least 2037.
About the INSPIRE Phase 3 Clinical
Trial
The clinical trial
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
higher-risk MDS (HR-MDS) patients who had progressed on, failed to
respond to, or relapsed after previous treatment with a
hypomethylating agent (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. 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. The trial continued beyond the pre-specified interim
analysis and is nearing its conclusion. 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 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
HR-MDS after failure of HMA therapy.
About Oral Rigosertib
The oral form of rigosertib was developed to
provide a potentially more convenient dosage form 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 dosed with the oral formulation of
rigosertib in clinical trials. 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 (ASH) Annual Meeting in December 2018. The data will be
updated at the upcoming 2019 ASH Annual Meeting next week.
About Inceptua
Inceptua is a pharmaceutical company and
service partner spanning throughout the product lifecycle – from
comparator sourcing for clinical trials, through early access
programs to licensing and commercialization for products.
We partner with life science companies of all
sizes, drawing on over 20 years of industry experience. Our pharma
and biotech offering includes registration and commercialization of
products through in-licensing and flexible partnerships. We have
leading expertise in strategy and operational implementation of
pre-approval access programs making pharmaceutical products under
clinical development available for patients and Inceptua’s clinical
trial services business offers high quality clinical comparator
sourcing and manufacturing services with an agile global supply
chain to ensure that products are delivered exactly when
needed.
Inceptua Medicines Access is a business unit of
the Inceptua Group. It offers full access solutions for the design,
implementation and delivery of Pre-approval and Medicines Access
Programs on behalf of biopharmaceutical companies.
Inceptua has global operations with local
offices across Europe, USA, and Asia.
www.inceptua.com
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" 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, maintain its Nasdaq listing, the need for additional
financing, the success and timing of Onconova's clinical trials and
regulatory approval of protocols, our collaborations, 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 Contacts:Mark
CorbettExecutive Vice PresidentInceptua Medicines Access+44 20 3910
7600mark.corbett@inceptua.com
Avi Oler Onconova Therapeutics, Inc.
267-759-3680ir@onconova.ushttp://www.onconova.com/contact/
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