Lisata Therapeutics Announces Full Enrollment of Pancreatic Cancer Cohort of CENDIFOX Trial
Lisata Therapeutics announced the successful completion of patient enrollment for the pancreatic cancer cohort in their Phase 1b/2a CENDIFOX trial. This trial, conducted at the University of Kansas Cancer Center, is assessing the safety and efficacy of combining certepetide with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. A total of 51 patients will be enrolled, and the study will provide valuable pre- and post-treatment tumor tissue data for immune profiling. The trial is funded by the KU Cancer Center, with Lisata supplying certepetide. The company is looking forward to completing enrollment in the remaining cohorts and reporting results.
- Successful completion of patient enrollment for the pancreatic cancer cohort in the CENDIFOX trial.
- Collaboration with the University of Kansas Cancer Center, a reputable institution.
- The trial aims to provide valuable pre- and post-treatment tumor tissue data for immune profiling.
- The study is designed to assess both safety and therapeutic effects, which can guide future developments.
- Lisata is supplying certepetide, indicating active involvement and potential cost management.
- Successful completion of enrollment can positively impact investor confidence.
- The trial is still in early stages (Phase 1b/2a), which means it is far from commercial approval.
- Only 51 patients are enrolled, which is a relatively small sample size and may limit the robustness of the data.
- The trial is open-label, which can introduce bias and affect the reliability of the results.
- No data on current financial expenditure for the trial, which could imply hidden costs.
Insights
Lisata Therapeutics has taken a significant step in the realm of pancreatic cancer research by completing patient enrollment for its CENDIFOX trial. This milestone is important because pancreatic cancer is notoriously aggressive with limited effective treatment options. The combination of certepetide with FOLFIRINOX represents a novel therapeutic approach that could potentially enhance patient outcomes.
The trial’s design to combine these therapies aims to leverage certepetide’s mechanisms to increase the efficacy of existing chemotherapy regimens. While safety and efficacy are primary focuses, the collection of pre- and post-treatment tumor tissue data for immune profiling could offer deeper insights into how these treatments work at a molecular level. This is valuable for the broader oncology community as it can guide future therapeutic strategies.
The engagement with a reputed institution like The University of Kansas Cancer Center adds credibility to the study’s findings. However, it's essential for retail investors to remember that while full enrollment is a positive step, results from clinical trials can take time and the outcomes may vary. The trial will need to demonstrate clear, positive results to impact the treatment landscape and justify long-term investments.
Completing patient enrollment for the pancreatic cancer cohort in the CENDIFOX trial is a noteworthy development for Lisata Therapeutics. From a financial perspective, this milestone can translate to increased investor confidence and potential stock appreciation. The final phase of patient enrollment typically garners attention because it indicates the trial is progressing without significant setbacks, which can be a positive signal for potential investors.
However, retail investors should consider the financial implications of this trial in a broader context. Clinical trials, particularly in oncology, are resource-intensive and the return on investment is contingent on the trial's success and subsequent regulatory approvals. Additionally, the trial is funded by an external entity (KU Cancer Center), which means Lisata might be mitigating some financial risks traditionally associated with such studies.
Investors should watch for interim results and any preliminary data that may be released. Such data can provide early indicators of the trial’s success and impact Lisata’s valuation. Nonetheless, caution is warranted given the inherent unpredictability of clinical trial outcomes and the competitive landscape in oncology therapeutics.
Phase 1b/2a open-label trial in the U.S. of certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers
BASKING RIDGE, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, announced today the successful completion of patient enrollment for the pancreatic cancer cohort in the Phase 1b/2a CENDIFOX trial. This investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas (“KU”) Cancer Center, is evaluating the safety and efficacy of certepetide (formerly LSTA1) in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers.
“The successful enrollment of the pancreatic cancer cohort represents another significant step forward in the clinical development of certepetide,” said Dr. Kristen K. Buck, Lisata’s Executive Vice President of Research and Development and Chief Medical Officer. “We are encouraged by the progress of the CENDIFOX trial and look forward to both the completion of enrollment in the remaining two cohorts and the reporting of results.”
The open-label CENDIFOX trial is designed to assess the safety and therapeutic effects of combining certepetide with neoadjuvant FOLFIRINOX regimens, with or without panitumumab, across pancreatic, colon, and appendiceal cancers. The study, conducted solely at the KU Cancer Center, aims to enroll a total of 51 patients (21 resectable and borderline resectable pancreatic cancer patients, 15 high-grade colon and appendiceal cancer patients with peritoneal metastasis, and 15 colon cancer patients with oligo-metastatic disease). It will provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. The trial is funded by the KU Cancer Center and Lisata is supplying certepetide.
“We are excited to collaborate with Lisata and encouraged by certepetide’s potentially diverse applicability,” said Dr. Anup Kasi, the study’s Principal Investigator at the KU Cancer Center. “We are eager to finish enrolling participants in the remaining study cohorts and to analyze the findings of each group to determine its efficacy.”
For more information on the CENDIFOX trial, please visit https://www.clinicaltrials.gov/study/NCT05121038.
About Certepetide
Certepetide (formerly LSTA1) is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has the potential to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, certepetide (formerly LSTA1), is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next two years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For more information on the Company, please visit www.lisata.com.
Forward-Looking Statements
This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, future revenue, projected expenses and capital, prospects, plans, and objectives of management are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with metastatic pancreatic ductal adenocarcinoma and other solid tumors, statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 29, 2024, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Investors:
Lisata Therapeutics, Inc.
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com
Media:
ICR Westwicke
Elizabeth Coleman
Senior Associate
Phone: 203-682-4783
Email: elizabeth.coleman@westwicke.com
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