Panbela to Present at the LD Micro Investor Conference
19 Setembro 2023 - 9:15AM
Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical-stage
biopharmaceutical company developing disruptive therapeutics for
the treatment of patients with urgent unmet medical needs,
announced today that management will be presenting at the LD Micro
Conference on Wednesday, October 4, 2023, at 3:30pm PT. The
presentation will be streamed live and available for replay at:
https://me23.sequireevents.com/ .
For more information about the conference or to schedule a
one-on-one in person meeting with management contact your
conference representative or email James@HaydenIR.com.
About our 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, ovarian cancer and diabetes. The combined development
programs have a steady cadence of catalysts with programs ranging
from pre-clinical to registration studies.
SBP-101 IvospeminIvospemin
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. 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 EflornithineCPP-1X (eflornithine) is
being developed as a single agent tablet or high dose power sachet
for several indications including prevention of gastric cancer and
recent onset Type 1 diabetes. Preclinical studies as well as Phase
1 or Phase 2 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
StatementsThis 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,”
“design,” “may,” “plan,” and “will.” Examples of forward-looking
statements include statements we make regarding timing of
trials and 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) our lack of diversification the
corresponding risk of an investment in our Company; (iii) our
ability to maintain our listing on a national securities
exchange; iv) progress and success of our clinical development
program; (v) our ability to demonstrate the safety and
effectiveness of our product
candidates: ivospemin ( SBP-101 ), Flynpovi ,
and eflornithine (CPP-1X) (v) our ability to obtain
regulatory approvals for our product candidates,
SBP-101, Flynpovi 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, Flynpovi 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, Flynpovi 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; ; 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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