Rexlemestrocel-L to be Highlighted at Maxim’s Panel on Late-Stage Advancements in Heart Failure Therapeutics and Management
July 11 2022 - 08:40PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced that rexlemestrocel-L, its allogeneic “off-the-shelf”
product candidate for the treatment of chronic heart failure (CHF)
with reduced ejection fraction (HFrEF), will be highlighted in a
panel discussion titled “Late-Stage Advancements in Heart Failure
Therapeutics and Management”, presented by Maxim Group LLC and
hosted by M-Vest, on Thursday, July 14th, 2022 at 10:00 a.m. ET.
The link to the webcast is available here.
Rexlemestrocel-L is being developed as an immunomodulatory
therapy to address the high degree of inflammation in the heart and
in the circulation that is present across the spectrum of HFrEF
patients, from New York Heart Association (NYHA) class II through
end-stage CHF, in order to reduce the high rate of major cardiac
events and complications. This investigational therapy has been
trialled in two large placebo-controlled randomized studies in
patients with CHF, a 565-patient trial in NYHA class II/III
patients with chronic heart failure and reduced ejection fraction
(HFrEF) and a 159-patient trial in end-stage chronic heart failure
(CHF) patients implanted with a left ventricular assist device
(LVAD). Rexlemestrocel-L has US Food and Drug Administration (FDA)
Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug
designations for patients with end-stage CHF implanted with an
LVAD.
Heart failure affects approximately 6.5 million people in the
United States and 26 million people globally, with increasing
prevalence and incidence. The mortality rate approaches 50% at 5
years as patients progress beyond NYHA class II disease in parallel
with increasing inflammation in the heart and in the
circulation.1,2 Despite recent approvals of new therapies for
HFrEF, including SGLT2 inhibitors, that have reduced
hospitalizations due to reversible volume-related events, NYHA
class II/III HFrEF patients with inflammation remain at high risk
for cardiac death, heart attacks and strokes. Over 60,000 patients
annually in the US progress to end-stage heart failure (NYHA class
IV) and these patients have a one-year mortality exceeding 50%.3
Use of LVADs in end-stage heart failure patients to improve
survival is gaining momentum, with approximately 5,500 LVADs
implanted annually in the US.4-6 However, systemic inflammation
associated with major life-threatening gastrointestinal bleeding
high rates of rehospitalization remain a major obstacle to greater
LVAD use.7,8
About Mesoblast Mesoblast is a world leader in
developing allogeneic (off-the-shelf) cellular medicines for the
treatment of severe and life-threatening inflammatory conditions.
The Company has leveraged its proprietary mesenchymal lineage cell
therapy technology platform to establish a broad portfolio of
late-stage product candidates which respond to severe inflammation
by releasing anti-inflammatory factors that counter and modulate
multiple effector arms of the immune system, resulting in
significant reduction of the damaging inflammatory process.
Mesoblast has a strong and extensive global intellectual
property portfolio with protection extending through to at least
2041 in all major markets. The Company’s proprietary manufacturing
processes yield industrial-scale, cryopreserved, off-the-shelf,
cellular medicines. These cell therapies, with defined
pharmaceutical release criteria, are planned to be readily
available to patients worldwide.
Mesoblast is developing product candidates for distinct
indications based on its remestemcel-L and rexlemestrocel-L
allogeneic stromal cell technology platforms. Remestemcel-L is
being developed for inflammatory diseases in children and adults
including steroid refractory acute graft versus host disease,
biologic-resistant inflammatory bowel disease, and acute
respiratory distress syndrome. Rexlemestrocel-L is in development
for advanced chronic heart failure and chronic low back pain. Two
products have been commercialized in Japan and Europe by
Mesoblast’s licensees, and the Company has established commercial
partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United States and
Singapore and is listed on the Australian Securities Exchange (MSB)
and on the Nasdaq (MESO). For more information, please see
www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter:
@Mesoblast
Footnotes
- AHA’s 2017 Heart Disease and Stroke Statistics
- Ponikowski P., et al. Heart Failure: Preventing disease and
death worldwide. European Society of Cardiology. 2014; 1: 4-25
- Gustafsson F, Rogers JG. Left ventricular assist device therapy
in advanced heart failure: patient selection and outcomes. European
Journal of Heart Failure 2017;19:595-602.
- United Network for Organ Sharing
- Agency for Healthcare Research and Quality – Healthcare Cost
and Utilization Project – Claims Analysis ICD- 37.6.
- Data on file
- Chatterjee A, Feldmann C, Hanke JS (2018) The momentum of
HeartMate 3: a novel active magnetically levitated centrifugal left
ventricular assist device (LVAD). J Thorac Dis 10 (Suppl 15):
S1790-S1793.
- Mehra, MR Salerno C, Cleveland JC (2018) Health care resources
use and cost implications in the MOMENTUM 3 long-term outcome
study: a randomized controlled trial of a magnetically levitated
cardiac pump in advanced heart failure.
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Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications
/ Investors |
Media |
Paul Hughes |
Sumit Media |
T: +61 3 9639 6036 |
Grant Titmus |
E: investors@mesoblast.com |
T: +61 419 388 161 |
|
E: grant@sumitmedia.com.au |
|
|
|
Rubenstein |
|
Tali Mackay |
|
E: tmackay@rubenstein.com |
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