Panbela Expands Aspire Trial to Australia, Studying SBP-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
August 04 2022 - 9:00AM
Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company
developing disruptive therapeutics for the treatment of patients
with urgent unmet medical needs, today announced it has received
approval from the Australian Human Research Ethics Committee (HREC)
to expand the company’s global clinical trial to Australia, to
study SBP-101 in combination with Gemcitabine and Nab-Paclitaxel in
patients with metastatic pancreatic ductal adenocarcinoma, which is
referred to as the ASPIRE trial. The ASPIRE trial is designed as a
randomized double-blind placebo-controlled trial, with a primary
endpoint of overall survival.
Australia marks the second country activated, with approximately
90 additional sites expected to be activated across 10 countries by
early 2023. Panbela has commenced screening for eligible patients,
with enrollment to the interim analysis expected to complete in
early 2024.
About our Pipeline
The pipeline consists of assets currently in clinical trials
with an initial focus on familial adenomatous polyposis (FAP),
first-line metastatic pancreatic cancer, neoadjuvant pancreatic
cancer, colorectal cancer prevention and ovarian cancer. The
combined development programs have a steady cadence of catalysts
with programs ranging from pre-clinical to registration
studies.
SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce
polyamine metabolic inhibition (PMI) by exploiting an observed high
affinity of the compound for pancreatic ductal adenocarcinoma and
other tumors. The molecule has shown signals of tumor growth
inhibition in clinical studies of US and Australian metastatic
pancreatic cancer patients, demonstrating a median overall survival
(OS) of 14.6 months which is final, and an objective response rate
(ORR) of 48%, both exceeding what is seen typically with the
standard of care of gemcitabine + nab-paclitaxel suggesting
potential complementary activity with the existing FDA-approved
standard chemotherapy regimen. In data evaluated from clinical
studies to date, SBP-101 has not shown exacerbation of bone marrow
suppression and peripheral neuropathy, which can be
chemotherapy-related adverse events. Serious visual adverse events
have been evaluated and patients with a history of retinopathy or
at risk of retinal detachment will be excluded from future SBP-101
studies. The safety data and PMI profile observed in the current
Panbela sponsored clinical trial provides support for continued
evaluation of SBP-101 in a randomized clinical trial. For more
information, please
visit https://clinicaltrials.gov/ct2/show/NCT03412799 .
Flynpovi™
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac
with a dual mechanism inhibiting polyamine synthesis and increase
polyamine export and catabolism. In a Phase 3 clinical trial in
patients with sporadic large bowel polyps, the combination
prevented > 90% subsequent pre-cancerous sporadic adenomas
versus placebo. Focusing on FAP patients with lower
gastrointestinal tract anatomy in the recent Phase 3 trial
comparing Flynpovi to single agent eflornithine and single agent
sulindac, FAP patients with lower GI anatomy (patients with an
intact colon, retained rectum or surgical pouch), Flynpovi showed
statistically significant benefit compared to both single agents
(p≤0.02) in delaying surgical events in the lower GI for up to four
years. The safety profile for Flynpovi did not significantly differ
from the single agents and supports the continued evaluation of
Flynpovi for FAP.
CPP-1X
CPP-1X (eflornithine) is being developed as a single agent
tablet or high dose power sachet for several indications including
prevention of gastric cancer, treatment of neuroblastoma and recent
onset Type 1 diabetes. Preclinical studies as well as Phase 1 or
Phase 2 investigator-initiated trials suggest that CPP-1X treatment
is well tolerated and has potential activity.
About Panbela
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing disruptive therapeutics for patients with urgent
unmet medical needs. The company’s lead assets are SBP-101 and
Flynpovi Further information can be found
at www.panbela.com. Panbela
Therapeutics, Inc. common stock is listed on The Nasdaq Stock
Market LLC under the symbol PBLA.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking
statements,” including within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be
identified by words such as: “believe,” “design,” “expect,” “feel,”
“intend,” “may,” “plan,” “scheduled,” and “will.” Examples of
forward-looking statements include statements we make regarding
results of collaborations with third parties and future studies.
All statements other than statements of historical fact are
statements that should be deemed forward-looking
statements. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are
based only on our current beliefs, expectations, and assumptions
regarding the future of our business, future plans and
strategies, projections, anticipated events and trends, the economy
and other future conditions. Because forward-looking statements
relate to the future, they are subject to inherent uncertainties,
risks and changes in circumstances that are difficult to predict
and many of which are outside of our control. Our actual
results and financial condition may differ materially and adversely
from the forward-looking statements. Therefore, you should not
rely on any of these forward-looking statements. Important
factors that could cause our actual results and financial condition
to differ materially from those indicated in the forward-looking
statements include, among others, the following: (i) our ability to
obtain additional funding to execute our business and clinical
development plans; (ii) progress and success of our clinical
development program; (iii) the impact of the current COVID-19
pandemic on our ability to conduct our clinical trials; (iv) our
ability to demonstrate the safety and effectiveness of our product
candidates: SBP-101 and eflornithine (v) our reliance on a third
party for the execution of the registration trial for our product
candidate Flynpovi; (vi) our ability to obtain regulatory approvals
for our product candidates, SBP-101 and eflornithine in the United
States, the European Union or other international markets; (vii)
the market acceptance and level of future sales of our product
candidates, SBP-101 and eflornithine; (viii) the cost and delays in
product development that may result from changes in regulatory
oversight applicable to our product candidates, SBP-101 and
eflornithine; (ix) the rate of progress in establishing
reimbursement arrangements with third-party payors; (x) the effect
of competing technological and market developments; (xi) the costs
involved in filing and prosecuting patent applications and
enforcing or defending patent claims; and (xi) such other factors
as discussed in Part I, Item 1A under the caption “Risk Factors” in
our most recent Annual Report on Form 10-K, any additional risks
presented in our Quarterly Reports on Form 10-Q and our Current
Reports on Form 8-K. Any forward-looking statement made by us in
this press release is based on information currently available to
us and speaks only as of the date on which it is made. We
undertake no obligation to publicly update any forward-looking
statement or reasons why actual results would differ from those
anticipated in any such forward-looking statement, whether
written or oral, whether as a result of new
information, future developments or otherwise.
Contact Information:
Investors:James CarbonaraHayden IR(646)
755-7412james@haydenir.com
Media:Tammy GroenePanbela Therapeutics, Inc.(952)
479-1196IR@panbela.com
Panbela Therapeutics (NASDAQ:PBLA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Panbela Therapeutics (NASDAQ:PBLA)
Historical Stock Chart
From Sep 2023 to Sep 2024