Onconova Announces First Patient Dosed in Investigator-Initiated Phase 2 Study of Rigosertib in Recessive Dystrophic Epidermo...
April 22 2021 - 8:00AM
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a
clinical-stage biopharmaceutical company focused on discovering and
developing novel products for patients with cancer, announced today
that the first patient has been dosed in an investigator-initiated
Phase 2 study to assess the efficacy and safety of rigosertib in
patients with recessive dystrophic epidermolysis bullosa
(RDEB)-associated locally advanced/metastatic squamous cell
carcinoma (SCC). The patient was dosed at the EB House Austria, a
center of expertise for epidermolysis bullosa at the University
Hospital Salzburg, Austria. Additional sites are anticipated to be
opened in the UK and in the US to study this rare and genomically
driven devastating disease.
In this open-label investigator-initiated study,
12 patients will receive either oral or intravenous rigosertib at
the clinician’s discretion given the various clinical
manifestations of the disease, which may dictate the need for
either oral or intravenous administration of rigosertib. These
patients have skin desquamation making intravenous access
difficult, or may form esophageal strictures, which make oral
administration difficult. Patients will receive either oral
rigosertib in four-week cycles (three weeks on, one week off) for
up to 13 cycles, with 560 mg of oral rigosertib in the morning and
again in the afternoon, for a total of 1,120 mg/day. Alternatively,
patients will receive intravenous (IV) rigosertib as a 72-hour IV
infusion on days 1, 2 and 3 of eight 2-week cycles, and on days 1,
2 and 3 of nine 4-week cycles thereafter, with each 24-hour
infusion consisting of 1,800 mg of rigosertib.
The study has two primary endpoints. The first
is to determine the anti-tumor activity of rigosertib in RDEB
patients with advanced SCC who have failed prior standard of care
through the overall response rate (ORR), defined as the proportion
of patients who achieve either a complete response (CR) or a
partial response (PR). The second primary endpoint is to evaluate
the safety and tolerability of rigosertib in this population.
Secondary study endpoints include quality of life and a biomarker
analysis performed on archival tissue from all patients. Patients
will be dosed for up to one year, with trial duration anticipated
to be approximately two-and-a-half years.
“We are pleased with the advancement of our
investigator-initiated programs with rigosertib, and to provide
rigosertib in support of this important Phase 2
investigator-sponsored study,” said Steven M. Fruchtman, M.D.,
President and Chief Executive Officer of Onconova Therapeutics.
“Recessive dystrophic epidermolysis bullosa is a genetic skin
blistering disease that often results in squamous cell carcinoma in
severe subtypes. In this patient cohort, squamous cell carcinoma is
the leading cause of death. We have previously identified polo-like
kinase 1 as a therapeutic target in skin SCC, including RDEB SCC,
so we are encouraged by the start of this trial. We hope rigosertib
can prove beneficial to this rare patient population with a
tremendous unmet medical need.”
In addition to Onconova Therapeutics, the study
is being supported by DEBRA
International. “The aggressive course
and poor prognosis of skin cancer in our patients emphasize the
urgent need for potent therapies,” stated Professor Johann W.
Bauer, M.D., Principal investigator of the trial. “We hope that
rigosertib as an innovative approach provides benefit to this
devastating illness that currently lacks effective therapies.”
“Basic research has provided understanding into
the etiology of Recessive Dystrophic Epidermolysis
Bullosa-associated cancer,” stated Andrew South Ph.D., Associate
Professor, Department of Dermatology & Cutaneous Biology,
Thomas Jefferson University. “I would like to thank both the Debra
Foundations for funding this work as well as Onconova for providing
a research drug that may target the life-threatening cancers
arising in these patients.”
About Onconova Therapeutics
Onconova Therapeutics is a clinical-stage
biopharmaceutical company focused on discovering and developing
novel products for patients with cancer. The Company has
proprietary targeted anti-cancer agents designed to disrupt
specific cellular pathways that are important for cancer cell
proliferation.
Onconova’s novel, proprietary multi-kinase
inhibitor ON 123300 is planned to begin a dose-escalation and
expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation
and expansion Phase 1 trial is currently underway in China.
Onconova’s product candidate oral rigosertib is
being studied in an investigator-initiated study program, including
in a dose-escalation and expansion Phase 1 investigator-initiated
study targeting patients with KRAS+ lung adenocarcinoma in
combination with nivolumab. In addition, Onconova continues to
conduct preclinical work investigating rigosertib in COVID-19.
For more information, please visit
www.onconova.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’s expectations regarding the
registered direct offering, its patents and clinical development
plans including patient enrollment timelines and indications for
its product candidates. 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 the success and
timing of Onconova's clinical trials and regulatory agency and
institutional review board approvals of protocols, Onconova’s
ability to continue as a going concern, the need for additional
financing, Onconova’s collaborations, market conditions 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.
Company Contact:Avi
OlerOnconova Therapeutics, Inc.267-759-3680ir@onconova.us
https://www.onconova.com/contact/
Investor Contact:LHA Investor
RelationsKim Sutton Golodetz212-838-3777kgolodetz@lhai.com
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