[ad_1]
NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO, ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the U.S. FDA has approved Lexulmestrocel L announced that it will support an accelerated approval pathway for Mesoblast’s allogeneic mesenchymal progenitor cell (MPC) product in end-stage ischemic heart failure patients with reduced ejection fraction (HFrEF) and left ventricular assist device (LVAD). FDA provided this feedback to the company in formal minutes following a Type B meeting held with FDA regarding rexlemestrocel-L (Revascor) on February 21, 2024.®) under the existing Regenerative Medicine Advanced Therapies (RMAT) designation.
“We are very pleased with the FDA feedback that the results presented from the pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support accelerated approval,” CEO of Mesoblast , said Dr. Silviu Itescu. “We intend to request a pre-Biologics License Application (BLA) meeting to discuss FDA’s expectations for data presentation, timing, and acceleration of the regulatory filing.”
More than 100,000 patients in the United States progress to end-stage HFrEF each year. For these patients, more than 2,500 life-sustaining LVADs are implanted each year in the United States, of which approximately 80% undergo surgery as a destination or permanent treatment.1 Most patients receiving LVAD as destination therapy have an ischemic HFrEF etiology. Compared with patients with non-ischemic HFrEF, patients with ischemic HFrEF have a 76% lower chance of recovering their LV function after LVAD implantation.2 And mortality increased during the first 1-2 years.3 The resistance to functional recovery in patients with ischemic HFrEF is thought to be due to excessive inflammation and microvascular insufficiency of the ischemic myocardium.Four
In the placebo-controlled LVAD-MPC study #2, 70 end-stage ischemic HFrEF patients received rexlemestrocel-L (150 million STRO3 immunoselected and culture-expanded allogeneic cells) at the time of LVAD implantation surgery. were randomly assigned to one of the 1 interventions. ) or a placebo directly into the left ventricular myocardium. The main findings are:
- Ischemic controls were characterized by persistently elevated levels of the inflammatory cytokine IL-6, reduced ability to wean from LVAD support, and high mortality.
- In contrast, in ischemic patients treated with rexlemestrocel-L, IL-6 levels returned to normal by 2 months and remained low until 12 months.
- 63% of ischemic patients who received a single dose of rexlemestrocel-L successfully achieved temporary weaning from full LVAD support as early as 2 months compared to 36% of the control group (p = 0.008).
- The cumulative incidence of successful temporary weaning from the LVAD device over 6 months was also increased by 1.55-fold in ischemic patients receiving Lexulmestrocel-L compared to controls.[95% CI 1.01, 2.36]; p=0.02).
- Only 4.9% of ischemic patients treated with a single dose of rexlemestrocel-L died between 2 and 12 months, compared with 26.9% of ischemic controls, an 82% reduction. (p = 0.02).
In the feedback provided to Mesoblast regarding a potential pathway to approval for rexlemestrocel-L, FDA comments stated that the results presented are consistent with the criteria for accelerated approval and that the clinical impact of MPC on mortality in LVAD patients is We have shown that there is a reasonable possibility of benefit.
Mesoblast plans to request a pre-BLA meeting with the FDA to discuss data presentation, timing, and FDA’s expectations for an accelerated approval application in patients with end-stage ischemic HFrEF who have undergone LVAD implantation.
About Revascall® In heart disease (rexlemestrocel-L)
REVASCOR is an allogeneic preparation of immunoselected, culture-expanded mesenchymal progenitor cells (MPCs) developed as an immunomodulatory therapy to address the high levels of inflammation in the heart and circulation present across the heart failure spectrum. It has been. We target patients with New York Heart Association (NYHA) class II to end-stage CHF ejection fraction (HFrEF) to reduce the high rate of major cardiac events and complications. This investigational therapy was tested in two large, placebo-controlled, randomized studies in patients with CHF, a 565-patient trial in patients with NYHA class II/III HFrEF, and a trial in patients with left ventricular assist devices. It is being tested in a 159-patient trial in patients with implanted end-stage HFrEF. Device (LVAD).
Rexlemestrocel-L has U.S. Food and Drug Administration (FDA) Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation for patients with end-stage HFrEF who have an LVAD implanted.
About chronic heart failure
Chronic heart failure (CHF) is characterized by decreased heart function and insufficient blood flow to the body’s vital organs and extremities. The condition affects approximately 6.5 million people in the United States and 26 million people worldwide, and its prevalence and incidence are increasing. CHF patients are typically classified according to New York Heart Association (NYHA) categories based on the patient’s physical limitations. Class I (mild) patients have no restrictions, while class IV patients (severe/terminal) have symptoms even at rest.
Mortality approaches 50% at 5 years as patients progress beyond the initial class II disease of NYHA in parallel with increased heart and circulatory inflammation.5,6 Despite the recent approval of new treatments for HFrEF, patients with NYHA class II/III HFrEF with inflammation remain at high risk for cardiac death, heart attack, and stroke.
More than 100,000 patients in the United States progress to end-stage heart failure (NYHA class IIIB/IV) each year, and the 1-year mortality rate for these patients exceeds 50%.7 The use of LVADs to improve survival in patients with end-stage heart failure is gaining momentum, with approximately 2,000 LVADs being implanted as intended therapy annually in the United States.1 The majority have an ischemic etiology.
About mesoblasts
Mesoblast (the Company) is a global leader in the development of allogeneic (off-the-shelf) cell medicines for the treatment of serious and life-threatening inflammatory conditions. The company leverages its proprietary mesenchymal cell therapy technology platform to respond to severe inflammation by releasing anti-inflammatory factors that counteract and modulate multiple effector arms of the immune system, resulting in significantly reduced inflammation. We have established an extensive portfolio of late-stage product candidates to help alleviate Effects of harmful inflammatory processes.
Mesoblast has a strong and extensive global intellectual property portfolio with extended protection in all major markets until at least 2041. The company’s proprietary manufacturing process results in industrial-scale, cryopreserved, off-the-shelf cell medicines. These cell therapies are designed to have defined drug release standards and be readily available to patients around the world.
Mesoblast is developing product candidates for different indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for pediatric and adult inflammatory diseases, including steroid-resistant acute graft-versus-host disease, biologic drug-resistant inflammatory bowel disease, and acute respiratory distress syndrome. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by his Mesoblast licensees, and the company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has offices in Australia, the US and Singapore and is listed on the Australian Stock Exchange (MSB) and Nasdaq (MESO). For more information, please visit www.mesoblast.com, LinkedIn: Mesoblast Limited, Twitter: @Mesoblast.
References/Footnotes
- Yuzef Polskaya M et al. Ann Thorak Surg 2023; 115:311-28
- Weber-Pinzon, Selzman CH, Stoddard G, et al. Impact of ischemic heart failure etiology on cardiac recovery upon mechanical unloading. J Am Coll Cardiol 2016;68:1741-1752. doi: 10.1016/j.jacc.2016.07.756.
- Mehra MR, Goldstein DJ, Cleveland JC, et al. His 5-year outcomes of patients treated with fully magnetically levitated left ventricular assist devices and axial flow left ventricular assist devices in the MOMENTUM 3 randomized trial. JAMA 2022; doi:10.1001/jama.2022.161972.
- Simmons JD, Dieter L, Dieter N et al. Effect of continuous flow left ventricular assist device support on coronary endothelial function in ischemic and non-ischemic cardiomyopathy. Sir Heart Fail 2019; 12:e006085. DOI: 10.1161/CIRCHEARTFAILURE.119.006085.
- AHA 2017 Heart Disease and Stroke Statistics
- Ponnikowski P., et al. Heart failure: Preventing disease and death around the world. European Society of Cardiology. 2014; 1:4-25
- Gustafsson F, Rogers JG. Left ventricular assist device therapy in advanced heart failure: patient selection and outcome. European Journal of Heart Failure 2017;19:595-602.
Forward-looking statements
This press release contains forward-looking statements that relate to future events or the Company’s future financial performance and are subject to known and unknown risks, uncertainties and the Company’s actual results, level of activity, and other factors that could cause performance or results to differ materially from future results. , the level of activity, performance or results expressed or implied by these forward-looking statements. The Company makes such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be construed as guarantees of future performance or results, and actual results may differ from those anticipated in these forward-looking statements, and such differences could be material. This may be disadvantageous. Forward-looking statements include, but are not limited to, statements regarding: Mesoblast’s preclinical and clinical studies and the initiation, timing, progress and results of Mesoblast’s research and development programs; Mesoblast’s ability to advance, enroll and successfully complete clinical studies, including multinational clinical trials, for its product candidates; the ability to improve Mesoblast’s manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any future decisions the FDA may make regarding the BLA of Remestemcell L for pediatric patients with SR-aGVHD), manufacturing activities and product marketing activities (if any); . commercialization of Mesoblast’s product candidates, if approved; regulatory or public awareness and market acceptance regarding the use of stem cell-based therapies; the potential for Mesoblast’s product candidates, if approved, to be withdrawn from the market due to adverse patient events or deaths; the potential benefits of strategic cooperation agreements and Mesoblast’s ability to enter into and maintain established strategic cooperation; Mesoblast’s ability to establish and maintain intellectual property with respect to its product candidates and Mesoblast’s ability to successfully defend against claims of infringement; the scope of protection that allows Mesoblast to establish and maintain intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s costs, future revenues, capital requirements and need for additional financing; Mesoblast’s financial performance. developments related to Mesoblast’s competitors and industry; If approved, Mesoblast’s product candidates will also be priced and reimbursed. This press release should be read in conjunction with the Company’s risk factors described in recent filings with the SEC or on the Company’s website. You should not place undue reliance on these forward-looking statements because of the uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to differ materially from those expressed or implied by such statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
Releases are approved by the Chief Executive Officer.
For more information, please contact us below.
Corporate Communication / For Investors | media |
Paul Hughes | blue dot media |
Phone: +61 3 9639 6036 | steve dabkowski |
E: investors@mesoblast.com | Phone: +61 419 880 486 |
E: steve@bluedot.net.au |
[ad_2]
Source link