Panbela Therapeutics, Inc. Completes Enrollment in its Phase 1b Trial Investigating SBP-101 Combination Therapy for First Lin...
08 Dezembro 2020 - 10:00AM
Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage
biopharmaceutical company developing disruptive therapeutics for
the treatment of patients with cancer, has completed patient
enrollment in its Phase 1 trial evaluating the safety and
tolerability of SBP-101 when used in combination with standard of
care agents gemcitabine and nab-paclitaxel for first-line treatment
of patients with metastatic pancreatic ductal adenocarcinoma
(PDA).
The trial, which included a dose escalation phase and an
expansion phase, enrolled 50 patients, 30 of whom were treated
using the dose and schedule that will advance to a randomized trial
of the combination versus gemcitabine and nab-paclitaxel alone
planned to begin in the first half of 2021. In total, the
safety of SBP-101 has been evaluated in 79 patients in two clinical
trials.
"We are pleased to have completed enrollment in our Phase 1b
trial and expect to announce data in the first half of next year,”
commented Jennifer Simpson, PhD., M.S.N., C.R.N.P. -
President & Chief Executive Officer. “Completing
enrollment for SBP-101 marks an important milestone in our quest to
bring new therapeutic options to patients with pancreatic cancer,
which is an orphan disease and an area of unmet medical need.”
SBP-101 is currently being evaluated in a Phase 1a/1b clinical
trial of patients with previously untreated metastatic PDA at sites
in the United States and Australia. SBP -101 has received Fast
Track and orphan drug designation from FDA. For more
information, please visit clinicaltrials.gov.
About SBP-101 SBP-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. The molecule has
shown signals of tumor growth inhibition in clinical studies of US
and Australian metastatic pancreatic cancer patients, suggesting
complementary activity with an existing FDA-approved chemotherapy
regimen. In clinical studies to date, SBP-101 has not shown
exacerbation of the typical chemotherapy-related adverse events of
bone marrow suppression and peripheral neuropathy. The safety data
and PMI profile observed in the current Panbela sponsored current
clinical trial provides support for continued evaluation of the
compound in a randomized clinical trial. For more
information, please visit
https://clinicaltrials.gov/ct2/show/NCT03412799.
About Panbela Therapeutics, Inc
Panbela 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 and in
treating other types of cancer. 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
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: “believes,” “ dedicated,” “expects,”
“intends,” “may,” “milestone,” or “plans.” Examples of
forward-looking statements include, among others, statements we
make regarding, potential effects of FDA Fast Track designation,
future determinations of the characteristics of SBP-101 and its
effectiveness, uses of proceeds from recent financings.
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; (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 Carbonara
Hayden IR
(646) 755-7412
james@haydenir.com
Media:
Tammy Groene
Panbela Therapeutics, Inc.
(952) 479-1196
IR@panbela.com
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