Boston (May 2, 2024)—Allarity
Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a
clinical-stage pharmaceutical company dedicated to developing
personalized cancer treatments, today announced the early
discontinuation of its Phase 2 clinical trial of stenoparib, a
novel PARP inhibitor, for the treatment of advanced recurrent
ovarian cancer. The patients enrolled in the trial had been
pre-screened by Allarity’s unique Drug Response predictor (DRP®)
companion diagnostic (CDx) in order to treat only patients with the
highest likelihood of deriving clinical benefit.
The trial, evaluating stenoparib given twice daily, has shown
clear clinical benefit, including tumor shrinkage and long-term
disease stability, in heavily pre-treated ovarian cancer patients
who otherwise have limited life expectancy. These results have
provided sufficient clinical proof of concept for stenoparib as
monotherapy, prompting Allarity to halt further enrollment in this
trial to enable and accelerate the development of a follow-on trial
with FDA regulatory intent.
"Based on the substantial clinical benefit observed in the early
stages of the trial, we have achieved proof of concept results that
surpassed our initial expectations and provided the critical
insights we were seeking," stated Thomas Jensen, CEO of Allarity
Therapeutics. "Concluding the trial now is the most effective way
to re-allocate our financial resources to develop a follow-on trial
with the fastest route to regulatory submission for stenoparib. The
patients enrolled in this trial are heavily pretreated, having
undergone multiple prior treatments, often including PARP
inhibitors. It is highly noteworthy that stenoparib, used in
patients selected with the DRP® CDx, has delivered sustained
clinical benefit for such very heavily pre-treated patients in the
trial.”
This Company’s decision will not affect the ongoing treatment of
current patients, as described in greater detail in Allarity’s
March 27, 2024, press release.
Allarity is committed to rapidly analyzing the trial data and
plans to present more comprehensive data as early as possible in a
clinical update. This early trial conclusion marks a significant
milestone in developing stenoparib, reflecting Allarity's
dedication to advancing stenoparib to address the urgent needs of
advanced ovarian cancer patients.
About Advanced, Recurrent Ovarian
CancerAdvanced, recurrent ovarian cancer refers to the
return of ovarian cancer after it has been treated. This condition
typically occurs in the later stages of the disease, which are
classified as stage III or IV at diagnosis. It is characterized by
the cancer's resistance to treatment, making its management
particularly challenging. The initial symptoms of ovarian cancer
can be very subtle, leading to a late diagnosis in many cases.
The recurrence of ovarian cancer is not uncommon, and it
significantly complicates the therapeutic landscape. The current
main goals of treating advanced, recurrent ovarian cancer are to
extend the patient's life while maintaining or improving their
quality of life, as curative options are limited. Treatment
strategies may involve a combination of surgery, chemotherapy,
targeted therapy, and, in some cases, radiation therapy. However,
the effectiveness of these treatments diminishes with each
recurrence, highlighting the need for innovative approaches to
manage the disease.
About the Drug Response Predictor – DRP® Companion
Diagnostic Allarity uses its drug-specific DRP® to select
those patients who, by the gene expression signature of their
cancer, are found to have a high likelihood of benefiting from a
specific drug. By screening patients before treatment, and only
treating those patients with a sufficiently high, drug-specific DRP
score, the therapeutic benefit rate may be significantly increased.
The DRP method builds on the comparison of sensitive vs. resistant
human cancer cell lines, including transcriptomic information from
cell lines combined with clinical tumor biology filters and prior
clinical trial outcomes. DRP is based on messenger RNA expression
profiles from patient biopsies. The DRP® platform has proven its
ability to provide a statistically significant prediction of the
clinical outcome from drug treatment in cancer patients dozens of
clinical studies (both retrospective and prospective). The DRP
platform, which can be used in all cancer types and is patented for
more than 70 anti-cancer drugs, has been extensively published in
the peer-reviewed literature.
About Allarity TherapeuticsAllarity
Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage
biopharmaceutical company dedicated to developing personalized
cancer treatments. The Company is focused on development of
stenoparib, a novel PARP/Tankyrase inhibitor for advanced ovarian
cancer patients, using its DRP® companion diagnostic for patient
selection in the ongoing phase 2 clinical trial, NCT03878849.
Allarity is headquartered in the U.S., with a research facility in
Denmark, and is committed to addressing significant unmet medical
needs in cancer treatment. For more information, visit
www.allarity.com.
Follow Allarity on Social MediaLinkedIn:
https://www.linkedin.com/company/allaritytx/X:
https://twitter.com/allaritytx
Forward-Looking Statements This press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements provide the Company’s current expectations or forecasts
of future events. The words “anticipates,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,”
“possible,” “potential,” “predicts,” “project,” “should,” “would”
and similar expressions may identify forward-looking statements,
but the absence of these words does not mean that a statement is
not forward-looking. These forward-looking statements include, but
are not limited to, statements regarding the potential benefits of
stenoparib for patients with advanced ovarian cancer, the DRP®, the
Company’s plans to rapidly advance towards a registration-focused
clinical trial, and the expected timing of the release of
comprehensive trial data. Any forward-looking statements in this
press release are based on management’s current expectations of
future events and are subject to multiple risks and uncertainties
that could cause actual results to differ materially and adversely
from those set forth in or implied by such forward-looking
statements. These risks and uncertainties include, but are not
limited to, Allarity’s ability to regain compliance with the
minimum bid price requirement and maintain its listing on Nasdaq,
the trading price of Allarity’s shares of common stock may be
volatile and other risks inherent in Allarity’s business,
including, the risk that the Company is not able to raise
sufficient capital to support its current and anticipated clinical
trials, the risk that early results of a clinical study do not
necessarily predict final results and that one or more of the
clinical outcomes may materially change following more
comprehensive reviews of the data, and as more patient data become
available, the risk that results of a clinical study are subject to
interpretation and additional analyses may be needed and/or may
contradict such results, the receipt of regulatory approval for
stenoparib or any of our other therapeutic candidates and companion
diagnostics or, if approved, the successful commercialization of
such products, the risk of cessation or delay of any of the ongoing
or planned clinical trials and/or our development of our product
candidates, the risk that the results of previously conducted
studies will not be repeated or observed in ongoing or future
studies involving our therapeutic candidates, and the risk that the
current COVID-19 pandemic will impact the Company’s current and
future clinical trials and the timing of the Company’s preclinical
studies and other operations. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause our actual results to differ from those contained in the
forward-looking statements, see the section entitled “Risk Factors”
in our Form S-1 registration statement filed on April 8, 2024, as
amended and our Form 10-K annual report on file with the Securities
and Exchange Commission (the “SEC”), available at the SEC’s website
at www.sec.gov, and as well as discussions of potential risks,
uncertainties and other important factors in the Company’s
subsequent filings with the SEC. All information in this press
release is as of the date of the release, and the Company
undertakes no duty to update this information unless required by
law.
###
Company Contact:
investorrelations@allarity.com
Media
Contact: Thomas
Pedersen Carrotize
PR &
Communications +45
6062 9390 tsp@carrotize.com
- Allarity Therapeutics Press Release - Stenoparib Shows Clear
Clinical Benefit and Achieves Significant Milestone
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