Panbela Announces First Patient Enrolled in its Aspire Trial Studying SBP-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
August 11 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 enrolled
the first patient in its global clinical trial 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, a randomized double-blind placebo-controlled
trial, with a primary endpoint of overall survival. Detailed
information on the trial can be located at
https://clinicaltrials.gov/ct2/show/NCT05254171.
“While site initiation was gradual, we are pleased with the
current momentum of the ASPIRE trial. We expect that a significant
number of global sites will be open by year-end with the full
complement of sites open by the first quarter 2023. Australia
opened last week with the first site activated within the country,
and now they’ve enrolled the first patient into the study,”
commented, Jennifer K. Simpson, PhD, MSN, CRNP, President &
Chief Executive Officer of Panbela. “Australian study centers have
been wonderful to work with and were important contributors to our
phase 1 trial, enrolling a heavy preponderance of the 50 patients.
We’re excited to reach this milestone of first patient enrolled, as
we move forward towards interim analysis which is expected to
complete in early 2024.”
Australia marked the second country activated for the ASPIRE
trial, and first to enroll, with approximately 90 additional sites
expected to be activated across 10 countries by early 2023.
Additionally, in response to European and FDA regulatory
feedback, the study was amended to include the total trial sample
size (600 subjects) and the design modified to utilize overall
survival as the primary endpoint to be examined at an interim
analysis. While the trial is expected to take approximately 36
months to fully enroll, the interim analysis is still expected to
occur 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
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