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 Mr. Abraham
“Avi” Oler has joined Onconova’s management team as Vice President,
Corporate Development and General Counsel. Mr. Oler will be
primarily responsible for business development, investor relations,
and legal affairs of the Company.
To help further advance Rigosertib, the
Company’s Phase 3 candidate for MDS, Mr. Oler’s focus will be on
forging new collaborations in additional geographies.
Rigosertib is currently partnered with SymBio Pharmaceuticals for
Japan and Korea, and with Pint Pharma for Latin America.
Information about partnering opportunities can be obtained via
e-mail at bd@onconova.us or via the Company’s website:
https://www.onconova.com/partnering.
Mr. Oler served most recently as Vice President
of Operations and Chief of Staff to the CEO of Spectrum
Pharmaceuticals. During his tenure, he was instrumental in
the company’s progress and productive licensing activities.
He served in varied roles of increasing responsibility, as a member
of the executive management team, the corporate development team,
and as Head of Alliances and Legal Affairs. Due to a series
of successful accomplishments, he was named Chief of
Staff.
Previously, Mr. Oler practiced corporate law at
the law firm of Kirkland & Ellis LLP. Prior to this, he
was a financial research analyst at the Center for Financial
Research & Analysis, and an investment banker with Lehman
Brothers in London.
“We are pleased to welcome Avi to Onconova,”
commented, Ramesh Kumar, Chief Executive Officer of Onconova.
“We believe Avi is an accomplished executive with the skill set and
track record that will enable us to achieve our business
development goals.” Dr. Steve Fruchtman, President of
Onconova, stated, “I have seen Avi use his varied talents to bring
success and value, and execute impactful transactions in similar
roles, and I look forward to his contributions to Onconova.
There has not been an FDA approved treatment for higher-risk MDS in
over a decade. The promising data from the Phase 2
combination trial of oral rigosertib and azacitidine (Vidaza®),
presented at an oral session on MDS on December 1st at the 2018 ASH
Annual Meeting, as well as the continued execution of the pivotal
INSPIRE trial in higher-risk MDS, make this a particularly exciting
time for Avi to join Onconova.”
“I am honored to join Onconova at such a
momentous time, and to showcase Onconova as a partner of choice,”
said Mr. Oler. “Onconova’s pipeline of clinical product
candidates, the advanced stage of development of Rigosertib, and
the recent promising data presented at the ASH 2018 Annual Meeting
make Onconova a compelling potential partner for other companies.
I am delighted to join my new colleagues at Onconova, to have
the opportunity to work with Steve again, and, along with the
Onconova Team and our Corporate Partners, work toward bringing a
new treatment option to patients with MDS.”
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.
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 and derives from the findings of the ONTIME Phase 3
trial. 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 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 for use where the duration of
treatment may extend to multiple years. This dosage form may also
support many combination therapy modalities. To date, 413
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. The results of a Phase 1/2 trial
combination therapy with azacitidine were presented at the 2018 ASH
Annual Meeting. 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" 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:
http://www.onconova.com/contact
Mark Guerin Onconova Therapeutics, Inc. 267 759 3680
Source: Onconova Therapeutics, Inc.
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