83% Survival in COVID-19 Patients with Moderate/Severe Acute Respiratory Distress Syndrome Treated in New York with Mesoblast...
April 24 2020 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced 83%
survival in ventilator-dependent COVID-19 patients (10/12) with
moderate/severe acute respiratory distress syndrome (ARDS) treated
during the period March-April 2020 with two intravenous infusions
of Mesoblast’s allogeneic mesenchymal stem cell product candidate
remestemcel-L within the first five days. 75% (9/12) have
successfully come off ventilator support at a median of 10 days. At
this time, seven have been discharged from the hospital. Patients
received a variety of experimental agents prior to remestemcel-L.
All patients were treated under an emergency Investigational New
Drug (IND) application or expanded access protocol at New York
City’s Mt Sinai hospital.
In contrast, only 9% (38/445) of ventilator-dependent COVID-19
patients at a major referral hospital network in New York City were
able to come off ventilator support when treated with standard of
care during March/April 2020.1 Moreover, there was 88% mortality
with only 12% survival (38/320) among ventilator-dependent COVID-19
patients at a second major referral hospital network in New York
City during the same period.2 These poor outcomes
are consistent with earlier published data from China where
mortality rates of over 80% were reported in patients with COVID-19
and moderate/severe ARDS.3
Mesoblast Chief Executive Dr Silviu Itescu stated: “The
remarkable clinical outcomes in these critically ill patients
continue to underscore the potential benefits of remestemcel-L as
an anti-inflammatory agent in cytokine release syndromes associated
with high mortality, including acute graft versus host disease and
COVID-19 ARDS. We intend to rapidly complete the randomized,
placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to
rigorously confirm that remestemcel-L improves survival in these
critically ill patients.”
Mesoblast Chief Medical Officer Dr Fred Grossman said: “There is
a significant need to improve the dismal survival outcomes in
COVID-19 patients who progress to ARDS and require ventilators. We
have implemented robust statistical analyses in our Phase 2/3 trial
as recommended by the US Food and Drug Administration (FDA) in
order to maximize our ability to evaluate whether remestemcel-L
provides a survival benefit in moderate/severe COVID-19
ARDS.”
References1 Petrilli CM et al. Factors
associated with hospitalization and critical illness among 4,103
patients with COVID-19 disease in New York City. MedRxiv 2020 doi:
https://www.medrxiv.org/content/10.1101/2020.04.08.20057794v1.full.pdf
2 Richardson S et al. Presenting characteristics, comorbidities,
and outcomes among 5700 patients hospitalized with COVID-19 in the
New York City area. JAMA 2020. doi:10.1001/jama.2020.6775
3 Liu Y et al. Clinical features and progression of acute
respiratory distress syndrome in coronavirus disease 2019. MedRxiv
2020;
https://www.medrxiv.org/content/10.1101/2020.04.08.20057794v1.full.pdf
About MesoblastMesoblast Limited (Nasdaq:MESO;
ASX:MSB) is a world leader in developing allogeneic (off-the-shelf)
cellular medicines. The Company has leveraged its proprietary
mesenchymal lineage cell therapy technology platform to establish a
broad portfolio of commercial products and late-stage product
candidates. Mesoblast’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’s Biologics License Application to seek approval of
its product candidate RYONCIL™ (remestemcel-L) for
steroid-refractory acute graft versus host disease (acute GVHD) has
been accepted for priority review by the United States Food and
Drug Administration (FDA). Remestemcel-L is also being developed
for other rare diseases. Mesoblast is completing Phase 3 trials for
its product candidates for advanced heart failure and chronic low
back pain. If approved, RYONCIL is expected to be launched in the
United States in 2020 for pediatric steroid-refractory
acute GVHD. 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 a strong and extensive global intellectual
property (IP) portfolio with protection extending through to at
least 2040 in all major markets. This IP position is expected to
provide the Company with substantial commercial advantages as it
develops its product candidates for these conditions.
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
Forward-Looking StatementsThis announcement
includes forward-looking statements that relate to future events or
our future financial performance and involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ
materially from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. We make 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 include, but are not limited to, statements about the
initiation, timing, progress and results of Mesoblast and its
collaborators’ clinical studies; Mesoblast and its collaborators’
ability to advance product candidates into, enroll and successfully
complete, clinical studies; the timing or likelihood of regulatory
filings and approvals; and the pricing and reimbursement of
Mesoblast’s product candidates, if approved; the potential
benefits of strategic collaboration agreements and Mesoblast’s
ability to maintain established strategic collaborations;
Mesoblast’s ability to establish and maintain intellectual property
on its product candidates and Mesoblast’s ability to successfully
defend these in cases of alleged infringement; the scope of
protection Mesoblast is able to establish and maintain for
intellectual property rights covering its product candidates and
technology. You should read this press release together with
our risk factors, in our most recently filed reports with the SEC
or on our website. Uncertainties and risks that may cause
Mesoblast’s actual results, performance or achievements to be
materially different from those which may be expressed or implied
by such statements, and accordingly, you should not place undue
reliance on these forward-looking statements. We do not undertake
any obligations to publicly update or revise any forward-looking
statements, whether as a result of new information, future
developments or otherwise.
Release authorized by the Chief Executive.
For further information, please contact:
MediaJulie MeldrumT: +61 3 9639
6036E:julie.meldrum@mesoblast.com |
Kristen BothwellT: +1 917 613 5434E:kbothwell@rubenstein.com |
|
|
InvestorsSchond
Greenway+212 880 2060E: schond.greenway@mesoblast.com |
Paul Hughes T: +61 3 9639
6036E: paul.hughes@mesoblast.com |
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