Lisata Therapeutics Announces First Patient Treated in the Phase 2a Trial of LSTA1 in Patients with Glioblastoma Multiforme
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Insights
The initiation of a Phase 2a clinical trial for LSTA1 in the treatment of glioblastoma multiforme (GBM) signifies a potential advancement in the therapeutic landscape for this aggressive brain tumor. GBM is notorious for its poor prognosis and limited treatment options, primarily due to the challenge of drug delivery across the blood-brain barrier (BBB). The BBB is a highly selective semipermeable border that separates the circulating blood from the brain extracellular fluid in the central nervous system. The preclinical evidence suggesting that LSTA1 can enhance penetration through the BBB could be a game-changer, as it may allow for more effective concentrations of the drug to reach the tumor site.
From an oncological perspective, the design of the study as a double-blind, placebo-controlled trial is crucial for validating the efficacy of LSTA1. The standard of care for GBM typically includes the chemotherapeutic agent temozolomide and the addition of LSTA1 will need to demonstrate a statistically significant improvement in outcomes to be considered a viable treatment option. The orphan drug designation by the U.S. FDA is also notable, as it provides certain benefits for the drug developer, including market exclusivity upon approval, which could hasten the development process and potentially bring the treatment to patients sooner.
Lisata Therapeutics' announcement of the Phase 2a trial commencement is a critical milestone that can have significant implications for the company's valuation. Investors often closely monitor the progress of clinical trials due to the potential for substantial market impact upon successful trial outcomes. The orphan drug designation for LSTA1 by the FDA is an encouraging regulatory milestone that can enhance investor confidence, as it often correlates with a streamlined review process and potential tax credits. Furthermore, the company's strategic decision to fund the study indicates a strong commitment to LSTA1's development program and a belief in its potential market viability.
The biotechnology sector is highly volatile, with stock prices sensitive to news of clinical trial progress. Positive results from this trial could lead to increased investor interest and potentially higher stock valuations for Lisata. On the other hand, any negative outcomes or serious adverse events could have the opposite effect. Therefore, the financial implications for stakeholders hinge on the success of the trial and the subsequent regulatory pathway, which could lead to significant revenue generation if LSTA1 is approved for GBM treatment.
The initiation of a Phase 2a trial in Estonia and Latvia for Lisata's LSTA1 represents a strategic move within the pharmaceutical industry to leverage global clinical research capabilities. Conducting studies across multiple international sites can offer advantages such as patient recruitment efficiency and diverse genetic backgrounds, which is particularly important in oncology trials where genetic factors can influence treatment responses. Additionally, the targeted enrollment of 30 patients with a 2:1 randomization in favor of LSTA1 treatment suggests a focused approach to yield statistically meaningful data.
From a market perspective, GBM represents a high unmet medical need with a limited number of effective treatments. If LSTA1 proves to be successful in enhancing treatment outcomes, it could capture a significant share of the GBM market. The study's proof-of-concept nature is designed to provide early evidence of efficacy, which, if positive, could attract partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies looking to expand their oncology portfolios.
BASKING RIDGE, N.J., Jan. 17, 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, today announced treatment of the first patient in a Phase 2a trial evaluating LSTA1 in patients with newly diagnosed glioblastoma multiforme (“GBM”). The trial is an investigator-initiated study by Lenne-Triin Kõrgvee, MD, PhD, principal investigator of the study. The first patient was enrolled at Tartu University Hospital in Tartu, Estonia.
The study is a Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (“SoC”), temozolomide, versus SoC and placebo in subjects with newly diagnosed GBM. The study is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:1 in favor of the LSTA1 treatment group. In addition to provisioning LSTA1, Lisata will also provide funding for this study. As previously announced by the Company, LSTA1 has been granted orphan drug designation by the U.S. FDA for malignant glioma.
“We are very pleased to announce the first patient treated in this Phase 2a study evaluating LSTA1 in patients with newly diagnosed GBM, a very aggressive brain tumor that is often fatal. We hold great hopes for the benefits of LSTA1 in this indication based on preclinical evidence that demonstrates LSTA1 enhances penetration through the limited permeability of the blood-brain barrier,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. "We appreciate the efforts of Dr. Kõrgvee and her team at Tartu University Hospital as well as those patients participating. We look forward to monitoring the results closely.”
“We are excited by the opportunity to work with Lisata and study LSTA1’s tumor targeting and penetrating technology in GBM,” Dr. Kõrgvee stated. “GBM has, historically, been very difficult to successfully treat and we believe LSTA1 may be an important tool in improving those outcomes for patients.”
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 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, LSTA1, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Based on Lisata’s CendR Platform® Technology, Lisata has already established noteworthy commercial and R&D partnerships. The Company expects to announce numerous clinical study and business milestones over the next two years and has projected that its current business and development plan is funded with available capital through these milestones and into early 2026. 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 LSTA-1 as a treatment for patients with glioblastoma multiforme, metastatic gastroesophageal 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 March 30, 2023, 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 and Media:
Lisata Therapeutics, Inc.
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com
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