Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage
biopharmaceutical company developing disruptive therapeutics for
the treatment of patients with urgent unmet medical needs announces
a poster presentation highlighting the results for CPP-1X (also
known as α-Difluoromethylornithine (DFMO) or Eflornithine) in
recent onset type 1 diabetes at the Immunology of Diabetes Society
(IDS) meeting, which was held May 23-27, 2023. The work reflects
the Company’s ongoing collaboration with Indiana University School
of Medicine.
The research is part of a multi-site clinical trial led by
Indiana University (IU) School of Medicine, supported by funding
from JDRF, the leading global type 1 diabetes (T1D) research and
advocacy organization. The preclinical data were generated by
Raghavendra Mirmira's laboratory at the University of Chicago.
Panbela Therapeutics is providing the drug at no cost to
researchers and was not involved in the design and analysis of
these studies.
“Preclinical studies showed that β cell-specific deletion of
ornithine decarboxylase (ODC) provided protection against
toxin-induced diabetes which suggests a role for polyamine
dysregulation in T1D.” said Jennifer K. Simpson, PhD, MSN, CRNP,
President & Chief Executive Officer of Panbela. “Furthermore,
results from the multi-site randomized, placebo-controlled Phase I
trial in patients with recent onset T1D showed that inhibition of
ODC by CPP-1X may improve β cell function.”
"Together these results suggest that CPP-1X may have a role in
the clinical management of recent onset type 1 diabetes,” said Dr.
Simpson “and are the basis for the IU and JDRF Phase II trial in
recent onset T1D that was recently initiated. Overall, we are
excited to support the goal of developing effective novel therapies
for patients with unmet medical needs.”
The poster investigates the mechanism of polyamines and
polyamine inhibition by CPP-1X on β cell stress that plays a role
in the onset of type 1 diabetes in in vitro and ex vivo models.
Mice with β cell-specific deletion of ODC had improved glucose
tolerance, increased β cell mass, and reduced incidence of diabetes
following streptozotocin treatment.
From the Phase 1 dose range finding study of CPP-1X in patients
with recent onset T1D, CPP-1X was well tolerated and a dose
dependent inhibition of ODC was observed. An exploratory secondary
analysis showed that at the two highest dose levels, treatment with
CPP-1X stabilized C-peptide areas under the curve compared to
placebo. When assessing immune cell populations, there were no
differences between the placebo and CPP-1X patients.
Results from these studies suggest that CPP-1X is a safe, oral
treatment option that may improve β cell function and/or survival
in recent onset T1D.
Details of the presentation are as follows:
Poster Presentation
Title: Inhibition of Polyamine Biosynthesis
with α-Difluoromethylornithine is Associated with Preserved β Cell
Function in Type 1 Diabetes
Session Category: Poster Session III
Session Title: Abstract #: 20
Additional meeting information can be found on the IDS website:
https://www.idsparis2023.com/_files/ugd/d65629_717d6a377fae45dc95b0ebb267fad8d7.pdf
The poster will also be available on the Company's website at
https://panbela.com/events-presentations/
About Panbela’s
PipelineThe 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 anticipated catalysts with programs ranging from
pre-clinical to registration studies.
Ivospemin (SBP-101)Ivospemin
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. It has shown signals of tumor growth inhibition in clinical
studies of metastatic pancreatic cancer patients, demonstrating a
median overall survival (OS) of 14.6 months and an objective
response rate (ORR) of 48%, both exceeding what is typical for 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, ivospemin 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 previous
Panbela-sponsored clinical trials provide support for continued
evaluation of ivospemin in the ASPIRE trial.
Flynpovi™Flynpovi is a
combination of CPP-1X (eflornithine) and sulindac with a dual
mechanism inhibiting polyamine synthesis and increasing polyamine
export and catabolism. In a Phase III 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 III 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), 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-1XCPP-1X (eflornithine) is being developed
as a single agent tablet or high dose powder sachet for several
indications including prevention of gastric cancer, treatment of
neuroblastoma and recent onset Type 1 diabetes. Preclinical studies
as well as Phase I or Phase II investigator-initiated trials
suggest that CPP-1X treatment may be well-tolerated and has
potential activity.
About PanbelaPanbela Therapeutics, Inc. is a
clinical-stage biopharmaceutical company developing disruptive
therapeutics for patients with urgent unmet medical needs.
Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further
information can be found at www.panbela.com
. Panbela’s 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: “anticipate,” “can,” “continue,”
“design,” “expect,” “focus,” “intend,” “may,” “plan,” “potential,”
and “will.” 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:
ivospemin (SBP-101) and eflornithine (CPP-1X); (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 CPP-1X 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 CPP-1X; (viii) the cost and delays
in product development that may result from changes in regulatory
oversight applicable to our product candidates, SBP-101 and CPP-1X;
(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; (xii) our ability to maintain the listing
of our common stock on a national securities exchange; and (xiii)
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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