MINNEAPOLIS, Sept. 29, 2022 (GLOBE NEWSWIRE) — Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical-stage company developing disruptive therapies for the treatment of patients with urgent unmet medical needs, announced today regulatory approval for the opening of trial sites in Spain, France and Italy for the clinical trial of Panbela in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global, randomized, double-blind, placebo-controlled clinical trial to evaluate ivospemine in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Detailed information about the trial can be found at https://clinicaltrials.gov/ct2/show/NCT05254171.
With approximately 95 sites planned in the United States, Europe, Australia, and South Korea, we continue to focus on site initiation and enrollment to ultimately provide a more effective treatment for pancreatic cancer. , a fatal disease with few treatment options. Site initiation can now accelerate and we are pleased with the current momentum of the ASPIRE trial. We expect a significant number of global sites to be open by the end of the year and 100% of sites to be open by the first quarter of 2023. “We are delighted to have these recent approvals as we moving towards the interim analysis which is expected to be completed in early 2024,” commented Jennifer K. Simpson, PhD, MSN, CRNP, President and CEO of Panbela.
About our pipeline
The pipeline includes 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 catalysts with programs ranging from preclinical studies to registration studies.
Ivospemin is a proprietary polyamine analog designed to induce polyamine metabolic inhibition (PMI) by exploiting the compound’s observed high affinity for pancreatic ductal adenocarcinoma and other tumors. It has shown tumor growth inhibition signals in clinical studies of patients with metastatic pancreatic cancer, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) by 48%, both exceeding what is typical of the standard of care. of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the standard FDA-approved chemotherapy regimen. In data evaluated from clinical studies to date, ivospemine has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which may be chemotherapy-related adverse events. Serious visual adverse events were assessed and patients with a history of retinopathy or at risk for retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in previous clinical trials sponsored by Panbela support the continued evaluation of ivospemin in the ASPIRE trial. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03412799 .
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism of inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented >90% of subsequent precancerous sporadic adenomas compared to placebo. Focusing on FAP patients with lower GI anatomy in the recent Phase 3 trial comparing Flynpovi to eflornithine monotherapy and sulindac monotherapy, FAP patients with lower GI anatomy (patients with intact colon, retained rectum, or surgical pouch), Flynpovi showed a statistically significant benefit over both single agents (p ≤ 0.02) in delaying lower GI surgical events for up to four years. The safety profile of Flynpovi did not differ significantly from that of single agents and supports the continued evaluation of Flynpovi for FAP.
CPP-1X (eflornithine) is being developed as a single-agent tablet or high-dose potent sachet for several indications, including gastric cancer prevention, treatment of neuroblastoma, and diabetes mellitus. type 1 of recent appearance. Preclinical studies as well as investigator-initiated Phase 1 or Phase 2 trials suggest that CPP-1X therapy may be well tolerated and has potential activity.
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapies for patients with urgent unmet medical needs. Panbela’s main 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”.
Caution 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 may be identified by words such as:“to anticipate“,“believe”, “conceive”, “expect”, “feel”, “intend”, “may”, “plan”, “expect” and “will”. Examples of forward-looking statements include statements we makeregarding the results of collaborations with third parties and future studies. All statements other than statements of historical fact are statements that should be considered forward-looking statements. Forward-looking statements are neither historical facts nor guarantees of future performance. Instead, they are based solely on our current beliefs, expectations and assumptions about the future of our business, Future plans and strategies, projections, anticipated events and trends, economic 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 beyond our control. Our actual results and financial condition may differ materially and adversely from forward-looking statements. Accordingly, you should not rely on any such forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those set forth in the forward-looking statements include, among others, the following: (I) our ability to obtain additional funds to execute our commercial and clinical development plans; (ii) the 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 efficacy of our product candidates:ivospemine(SBP-101)and eflornithine(RPC-1X)(v) our reliance on a third party to perform the registration trial of our product candidateFlynpovi; (vi) our ability to obtain regulatory approvals for our product candidates, SBP-101 andRPC-1Xin the United States, European Union or other international markets; (vii) the market acceptance and level of future sales of our product candidates, SBP-101 andRPC-1X; (viii) cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates, SBP-101 andRPC-1X; (ix) the rate of progress in setting up reimbursement agreements with third-party payers; (x) the effect of competing technological and market developments; (xi) costs relating to the filing and prosecution of patent applications and the enforcement or defense of patent claims; and (xi) any other factors as discussed in Part I, Item 1A under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, any additional risk disclosed in our Quarterly Reports on Form 10-Q and our current report. Reports on Form 8-K. Any forward-looking statement we make 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 update publicly any forward-looking statement or the reasons why actual results would differ from those anticipated in such forward-looking statement, whether written or oral, whether Consequently new information, future developments or otherwise.
Panbela Therapeutics, Inc.
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