Panbela Announces Positive Preclinical Data Strongly Supporting the Activity of SBP-101 in Ovarian Cancer Cell Lines; Development Program for SBP-101’s Expansion into Ovarian Cancer Expected in 1H 2022
December 14 2021 - 9:00AM
Panbela Therapeutics,
Inc. (Nasdaq: PBLA), a
clinical stage company developing disruptive therapeutics for the
treatment of patients with cancer, today announced positive
preclinical data supporting the activity of SBP-101 in ovarian
cancer cell lines. Panbela expects to launch a development effort
for SBP-101 in ovarian cancer in the first half of 2022 and will
host a virtual R&D day to discuss the new ovarian cancer
program early in the new year.
“The preclinical results illustrate SBP-101’s potential to
expand into another area of high unmet need,” said Jennifer K.
Simpson, PhD, MSN, CRNP, President & Chief Executive Officer.
“According to the American Cancer Society, ovarian cancer is the
fifth leading cause of cancer deaths among women, accounting for
more deaths than any other cancer of the female reproductive
system. Therefore, it is vital to progress new therapies such as
SBP-101 for ovarian cancer.”
As stated by the European Society for Medical Oncology (ESMO),
ovarian cancer represents a significant unmet need in gynecological
cancers, with the absence of well-defined screening programs and
inconsistent initial symptoms leading to late diagnosis in most
patients. Considered largely incurable, ovarian cancer typically
relapses within 3 years in 80% of women, with subsequent
recurrences arising sooner each time as resistance to chemotherapy
develops.
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
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. 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 .
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: “believe,” “expect,”
“intend,” “may,” and “plan.” Examples of forward-looking statements
include statements we make regarding our intention to continue to
innovate and build our patent portfolio. 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 a randomized
clinical trial; (ii) progress and success of our Phase 1 clinical
trial; (iii) the impact of the current COVID-19 pandemic on our
ability to complete monitoring and reporting in our current
clinical trial and procure the active ingredient; (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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