Panbela Exceeds 50% Enrollment for Aspire Trial in Pancreatic Cancer, Exceeding Anticipated Timelines with Accelerated Momentum
25 1월 2024 - 9:00PM
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 reached 50%
enrollment for its ASPIRE global clinical trial in the first-line
treatment of metastatic pancreatic cancer. ASPIRE is a global
randomized, double-blind placebo-controlled clinical trial to
evaluate ivospemin in combination with gemcitabine and
nab-Paclitaxel in patients with metastatic pancreatic ductal
adenocarcinoma. Detailed information on the trial can be located
at
https://clinicaltrials.gov/ct2/show/NCT05254171 .
“We’re thrilled to have surpassed 50% enrollment for the ASPIRE
trial and to be moving faster than originally projected,” said
Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief
Executive Officer of Panbela. “As we have reached the near full
complement of sites open and enrolling, we have seen a steady
cadence of enrollment, expecting full enrollment to be completed by
Q1 2025. We are looking forward to the interim data analysis based
on overall survival in mid-2024.”
In the global ASPIRE trial, there are approximately 90 sites up
and running throughout the United States, Europe, Australia, and
South Korea. Panbela is committed to delivering a more effective
treatment for pancreatic cancer, a deadly disease with few
treatment options.
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
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,” “believe,” “can,”
“design,” “expect,” “focus,” “intend,” “looking forward,” “may,”
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than statements of historical fact are statements that should be
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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
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We undertake no obligation to publicly update any forward-looking
statement or reasons why actual results would differ from those
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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)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Panbela Therapeutics (NASDAQ:PBLA)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024