Mesoblast Phase 3 Cell Therapy Trial for Chronic Low Back Pain Completes Enrollment
29 March 2018 - 09:25AM
Mesoblast Limited (ASX:MSB) (Nasdaq:MESO) today announced that
enrollment has completed in the Phase 3 trial evaluating
a single intra-discal injection of its proprietary
allogeneic mesenchymal precursor cell (MPC) product candidate
MPC-06-ID in patients with chronic low back pain due to
degenerative disc disease.
MPC-06-ID is being evaluated to determine whether
it can alleviate pain and improve function in patients who do not
receive adequate relief from current standard of care therapies
such as non-steroidal anti-inflammatory drugs, epidural steroid
injections or opioids.
The 2:1 randomized, placebo-controlled Phase 3 trial
(NCT02412735) enrolled 404 patients across 48 centers in the
United States and Australia. Following completion of the planned
enrollment of 360 patients, all additional patients still in
screening at that point were allowed to complete enrollment.
The Phase 3 trial's primary endpoint is in line with
written guidance from the United States Food and Drug
Administration (FDA) in support of product registration, and
specifies
- use of a composite measurement showing significant clinical
improvement in pain and function at both 12 and 24 months
- pre-specified thresholds for determining significant
improvement in pain (50% decrease in Visual Analog Score) and
function (15-point improvement in Oswestry Disability Index)
- patients who undergo additional interventions at the treated
level are considered treatment failures.
Phase 2 results in 100 patients showed that a single
intra-discal injection of MPC-06-ID alleviated pain and improved
function for up to three years in patients whose symptoms were not
adequately treated with current standard of care therapies.
Mesoblast Chief Executive Dr Silviu Itescu said, “There is an
urgent need to provide an effective treatment for patients
suffering from chronic low back pain due to degenerative disc
disease, a population which today accounts for 50% of prescription
opioid usage. If the Phase 3 results demonstrate durable
improvement in pain and function, MPC-06-ID has the potential to
make a major difference in patients with this serious medical
condition.”
About Chronic Low Back Pain (CLBP) Caused By
Degenerative Disc Disease Over 33 million1 patients in the
U.S. alone suffer from CLBP with approximately 22%2 caused by
degenerative disc disease. The patient population suffering from
chronic low back pain due to intervertebral disease is estimated at
more than 3.2 million patients in the U.S. alone3. Total costs of
low back pain in the U.S. are estimated at between US$100 billion
and US$200 billion annually with two thirds of these costs
attributed to patients’ decreased wages and productivity.4
All approved therapies for progressive, severe and debilitating
pain due to degenerating intervertebral discs treat the symptoms of
the disease, but are not disease-modifying and thus do not address
the underlying cause of the disease.
Limited treatment options exist for patients who have failed
conservative treatment such as physical therapy, anti-inflammatory
agents or analgesics as well as other measures including opioids
and epidural steroid injections. In the United States,
approximately 50% of opioid prescriptions are for chronic low back
pain5,6,7,8.
When disc degeneration has progressed to a point that pain and
loss of function can no longer be managed by conservative means,
major invasive surgery is the only remaining option. Even with
surgical intervention such as spinal fusion or artificial disc
replacement, between 30-46% of patients are considered treatment
failures.9
1. Decision Resources: Chronic Pain December 2015. 2. Verrilis
P, Nowesenitz G, Barnard A. (2015) Prevalence and Characteristics
of Discogenic Pain in Tertiary Practice: 223 Consecutive Cases
Utilizing Lumbar Discography. Pain Med. Aug; 16(8): 1490-93.
Mesoblast internal estimate from primary market research conducted
by Navigant and LEK.4. Katz JN. Lumbar disc disorders and low-back
pain: socioeconomic factors and consequences. J Bone Joint Surg Am.
2006;88 (suppl 2):21–24 5. Abdel Shaheed C et al. Efficacy,
Tolerability, and Dose-Dependent Effects of Opioid Analgesics for
Low Back Pain: A Systematic Review and Meta-analysis. JAMA Internal
Medicine . American Medical Association; 2016 Jul;176(7):958-68.6.
Pain Management Study: Chronic Pain, December 2013. Decision
Resources7. Hudson TJ et al. Epidemiology of Regular Prescribed
Opioid Use: Results from a National, Population-Based Survey.
Journal of Pain and Symptom Management. Elsevier; 2008
Sep;36(3):280-288.8. Sullivan MD et al. Regular use of prescribed
opioids: Association with common psychiatric disorders. Pain.
Wolters Kluwer; 2005 Dec 15;119(1-3):95-103.9. Chan C, Peng P.
Failed back surgery syndrome. Pain Med 2011;12:577–606.
About MesoblastMesoblast Limited (ASX:MSB)
(Nasdaq:MESO) is a global leader in developing innovative
cell-based medicines. The Company has leveraged its proprietary
technology platform, which is based on specialized cells known as
mesenchymal lineage adult stem cells, to establish a broad
portfolio of late-stage product candidates. Mesoblast’s allogeneic,
‘off-the-shelf’ cell product candidates target advanced stages of
diseases with high, unmet medical needs including cardiovascular
conditions, orthopedic disorders, immunologic and inflammatory
disorders and oncologic/hematologic conditions.
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 should not be read as a guarantee of future performance
or results, and actual results may differ from the results
anticipated in these forward-looking statements, and the
differences may be material and adverse. Forward-looking statements
include, but are not limited to, statements about: the initiation,
timing, progress and results of Mesoblast’s preclinical and
clinical studies, and Mesoblast’s research and development
programs; Mesoblast’s ability to advance product candidates into,
enroll and successfully complete, clinical studies, including
multi-national clinical trials; Mesoblast’s ability to advance its
manufacturing capabilities; the timing or likelihood of regulatory
filings and approvals, manufacturing activities and product
marketing activities, if any; the commercialization of Mesoblast’s
product candidates, if approved; regulatory or public perceptions
and market acceptance surrounding the use of stem-cell based
therapies; the potential for Mesoblast’s product candidates, if any
are approved, to be withdrawn from the market due to patient
adverse events or deaths; the potential benefits of strategic
collaboration agreements and Mesoblast’s ability to enter into and
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; estimates of
Mesoblast’s expenses, future revenues, capital requirements and its
needs for additional financing; Mesoblast’s financial performance;
developments relating to Mesoblast’s competitors and industry; and
the pricing and reimbursement of Mesoblast’s product candidates, if
approved. 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.
For further information, please contact:
Julie MeldrumCorporate CommunicationsT: +61 3 9639 6036E:
julie.meldrum@mesoblast.com
Schond GreenwayInvestor RelationsT: +1 212 880
2060E: schond.greenway@mesoblast.com
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