Panbela Initiates a Randomized, Double-Blind, Placebo-Controlled Study (ASPIRE) of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma
27 January 2022 - 1:00AM
Panbela Therapeutics, Inc. (Nasdaq: PBLA), a
clinical stage biopharmaceutical company developing disruptive
therapeutics for the treatment of patients with cancer, today
announced the initiation of the company’s global Phase 2 clinical
trial of SBP-101 in combination with Gemcitabine and Nab-Paclitaxel
in patients with metastatic pancreatic ductal adenocarcinoma, which
is referred to as the ASPIRE trial.
Arvind Chaudhry MD, PhD, Principal Investigator at Summit Cancer
Centers in Spokane, Washington was the first clinical site
activated, with approximately 60 additional sites expected to be
activated in 2022. Panbela has commenced screening for eligible
patients, with enrollment expected to complete in approximately 12
months.
The ASPIRE trial is designed as a randomized double-blind
placebo-controlled trial, with a primary endpoint of overall
survival. The design includes a futility analysis after 104
progression-free survival events. Panbela is seeking to conduct the
trial at leading cancer centers in the United States, Europe, and
the Asia-Pacific region.
“Pancreatic cancer is one of the most common causes of cancer
deaths in the United States and represents a significant unmet
medical need, as is underscored by SBP-101’s Fast Track and Orphan
Drug designations,” said Jennifer K. Simpson, PhD, MSN, CRNP,
President & Chief Executive Officer. “We are enthusiastic about
having initiated the ASPIRE global randomized Phase 2 trial. Given
the rigor of the trial design, we expect the resulting data to
support our registration effort.”
About SBP-101SBP-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
potential signals of tumor growth inhibition in clinical studies of
US and Australian metastatic pancreatic cancer patients, suggesting
potential complementary activity with an existing FDA-approved
standard chemotherapy regimen, if SPB-101 receives approval in the
US. 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 observed in the Company’s recently
completed Phase 1a/1b clinical trial 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 .
About PanbelaPanbela Therapeutics, Inc. is a
clinical-stage biopharmaceutical company developing disruptive
therapeutics for patients with urgent unmet medical needs. The
company’s initial product candidate, SBP-101, is for the treatment
of patients with metastatic pancreatic ductal adenocarcinoma, the
most common type of pancreatic cancer. Panbela Therapeutics, Inc.
is dedicated to treating patients with pancreatic cancer and
exploring SBP-101’s potential for efficacy in combination with
other agents in other cancer indications. 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
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: “design,” “expect,” “may,” “plan,”
“potential,” and “seek.” Examples of forward-looking statements
include statements we make regarding timing of enrollment and
conduct of the ASPIRE trial, participating sites, and
outcomes. 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 complete this randomized clinical trial; (ii)
completion and success of our Phase 1 clinical trial; (iii) the
impact of the current COVID-19 pandemic on our ability to
initiate clinical sites and complete enrollment in this clinical
trial; (iv) our ability to demonstrate the safety and effectiveness
of our SBP-101 product candidate (v) our ability to obtain
regulatory approvals for our SBP-101 product candidate in the
United States, the European Union or other international markets;
(vi) the market acceptance and level of future sales of our SBP-101
product candidate; (vii) the cost and delays in product development
that may result from changes in regulatory oversight applicable to
our SBP-101 product candidate; (viii) the rate of progress in
establishing reimbursement arrangements with third-party payors;
(ix) the effect of competing technological and market developments;
(x) 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) 479-1196 ext.
170IR@panbela.com
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