Enrollment completed approximately six months earlier than originally projected
Top-line placebo-controlled, blinded, randomized data now expected in the fourth quarter of 2024
The ASCEND trial is a 155-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial evaluating standard-of-care (“SoC”) gemcitabine and nab-paclitaxel vs SoC plus LSTA1 in patients with metastatic pancreatic ductal adenocarcinoma. LSTA1 is Lisata’s lead development candidate designed to augment the targeting to and penetration of anti-cancer drugs in solid tumors expressing a dense stromal barrier without exacerbating any adverse effects normally associated with those anti-cancer drugs. Study participants are randomized 2:1 in favor of study intervention (SoC + LSTA1) vs. SoC plus placebo. Cohort A, where patients received a single dose of LSTA1 plus SoC, has 80% power with 95% confidence to detect a 16% increase in the 6-month progression-free survival (“PFS”) rate in the experimental arm vs. the control arm (SoC + placebo). Cohort A dosing is identical to the dosing used in the previously reported Phase 1b/2a trial in which substantial improvement was shown in both PFS and overall survival (“OS”) in mPDAC patients administered LSTA1 plus SoC. Cohort B will assess whether a second dose of LSTA1, administered 4 hours after the original dose of LSTA1 plus SoC, will further improve patient outcomes. Both PFS and OS will be assessed in the trial. The trial is being conducted at up to 30 sites in
“The completion of enrollment in ASCEND is a vital step in the development of LSTA1; exceeding the original enrollment completion expectations and, as a result, accelerating the expected timeline for seminal data by nearly 12 months,” stated
About LSTA1
LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered (i.e., covalently bound) anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 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. LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies and RNA-based therapeutics. Additionally, LSTA1 has demonstrated favorable safety, tolerability, and activity in clinical trials to enhance delivery of SoC chemotherapy for pancreatic cancer. Lisata is exploring the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors more effectively.
About
About the AGITG
About the
As Australia’s first university – founded in 1850 – the
About the NHMRC Clinical Trials Centre,
The NHMRC Clinical Trials Centre is a flagship research centre of the Faculty of Medicine and Health at the
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, 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: 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
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Phone: 908-842-0084
Email: jmenditto@lisata.com
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