Cellular Biomedicine Group Announces Positive 48-Week Data From Phase IIb Clinical Trial for Knee Osteoarthritis Stem Cell ...
14 January 2016 - 12:00AM
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a biomedicine firm engaged in the development of
effective stem cell therapies for degenerative diseases and
immunotherapies for cancer, today announced positive 48-week
clinical data from the Phase IIb trial of its human adipose-derived
mesenchymal progenitor cell (haMPC) therapy ReJoin® for Knee
Osteoarthritis (KOA). The data was presented January 12th at the
8th Annual BioTech Showcase investor conference held in San
Francisco, CA.
The Company continues to be encouraged by the
latest data from its ReJoin® trials. Objective measurement of
cartilage volume by 3D SPGR quantitative magnetic resonance imaging
(MRI) indicated significant increase of cartilage volume following
ReJoin® therapy, as opposed to further cartilage deterioration
normally found in untreated patients1. The Company believes that
the opportunity for patients to regenerate their damaged knee
cartilage and improve the long-term quality of life using their own
stem cells could be more preferable than undergoing drug treatment
with adverse side effects or painful and invasive knee replacement
surgery or other invasive surgical procedures. The positive
preliminary results from these trials bring the Company closer to
commercialization of ReJoin® therapy in China, where there are more
than 57 million KOA patients with no approved KOA treatment for
structure modification available.
ReJoin® Phase IIb
48-week Data Analysis
The 48-week end of study data of 53 patients
shows the primary and secondary endpoints of ReJoin® therapy
group having all improved significantly compared to their baseline,
which has confirmed some of the Company’s Phase I/IIa results (view
report here). The total WOMAC scores (consisting of pain, stiffness
and function scores of joints) as a primary end point show
statistical treatment significance at week 48 compared to the
baseline. The total knee cartilage volume change measured by a
semi-automated segmentation method (ITK-SNAP) by two different
blinded researchers show significant gain of cartilage in the
ReJoin® group but a loss of cartilage in ARTZ@ group, reaching
statistical difference between the two groups 48 weeks after
therapy.
Highlights of the full 48-week follow-up
data:
- Western Ontario and McMaster Universities Arthritis
Index (WOMAC): significantly decreased by 9.48 (28.52%
improvement rate) in the ReJoin® group and by 6.92 (20.74%
improvement rate) in the ARTZ@ control group at week 48, but there
is no significant difference between the two groups. Subset
analysis of subject numbers with WOMAC improvement rate ≥ 50% and ≥
70% showed significant differences of ReJoin® group over the ARTZ@
group at 48th week after therapy (p=0.0038 and 0.0388,
respectively).
- 3D Spoiled Gradient-Recalled Echo
(SPGR) MRI Quantitative Assessment: The
cartilage volume of both knees together increased significantly by
302.06 mm3 in the ReJoin® group but decreased by 125.35
mm3 in ARTZ@ group at 48 week time point after therapy, reaching
high statistical difference (p=0.0007).
- Visual Analog Scale (VAS): Pain relief indices
as measured by VAS for the left and right knees show continued
improvement at 48 week (46.51% and 47.89%) compared to 24 week
(42.21% and 40.39%) over the baselines in the ReJoin® group.
The control ARTZ@ group has the scores of 16.47% and 10.82% at 48
week, 19.59% and 14.77% at 24 week, respectively. At both time
points there were statistically and significantly better
effects observed for ReJoin® treatment over the ARTZ® control
group.
- Short Form Health Survey (SF-36): The quality
of life endpoint measured by SF-36 questionnaire also shows
statistical improvement from the baseline at week 48 by 9.39 and
week 24 by 8.30 of the ReJoin® group over the ARTZ® control (3.92
and 3.38, respectively), with P value of 0.010 and
0.034.
- No serious adverse events reported to date.
About the
ReJoin® Phase IIb
trial for KOA
The Phase IIb is a randomized, double-blinded to
patients and evaluators, and controlled trial, which enrolled 53
patients in multiple clinical centers with a 48-week follow-up
duration. The endpoints were WOMAC score, VAS score, SF-36 score
and MRI cartilage volume. The trial is conducted in China and
registered with the U.S. National Institutes of Health (NIH) under
the number NCT02162693 (click here to view).
About the
ReJoin® Therapy
Cellular Biomedicine Group’s
ReJoin® therapy for KOA is an interventional therapy that
consists of 30ml of adipose (fat) tissue obtained via
lipoaspiration from the patient, from which the patient’s vascular
stromal cells (VSC; a combination of several types of monocytes
including mesenchymal stem cells) are isolated using CBMG’s
proprietary medical device, the A-StromalTM Kit, which produces a
high yield of VSC, and haMPCs are then expanded using CBMG’s
proprietary culture medium, and formulated for ReJoin® therapy
using CBMG’s proprietary formulation. After three weeks of cell
culture there is an initial injection into the knee joints and a
second injection three weeks later. The rest of the patient’s haMPC
are banked for potential future use.
Some of the special characteristics of
ReJoin® regenerative therapy for KOA are:
- Autologous – patient’s own cells
- No potential of immune rejection
- Readily available, easy to source via minimally invasive
lipoaspirate, only 30ml of adipose (fat) tissue required
- Unlimited supply of patient’s own cells from one
lipoaspirate
- Significant results, including cartilage regrowth, in as early
as 12 weeks, over the baseline from previous Phase I/IIa study, and
confirmed superiority over the control at 48 weeks in the Phase IIb
trial
- Relatively quick recovery compared to knee replacement
surgery
- Potential long term therapeutic effects
- No serious adverse events reported to date, from the Phase I,
Phase IIa and Phase IIb clinical trials
Further details of the clinical data may be
viewed on the Company’s website at the following link:
http://www.cellbiomedgroup.com/investor-relations/presentations/
- BMC Musculoskelet Disord. 2011 Aug 24;12:195. doi:
10.1186/1471-2474-12-195.
About Cellular Biomedicine
Group
Cellular Biomedicine Group, Inc. develops
proprietary cell therapies for the treatment of certain
degenerative and cancerous diseases. Our developmental stem
cell and Immuno-Oncology projects are the result of research and
development by scientists and doctors
from China and the United States. Our GMP facilities
in China, consisting of nine independent cell production lines, are
designed, certified and managed according to U.S. standards.
To learn more about CBMG, please visit:
www.cellbiomedgroup.com
Forward-Looking Statements
Statements in this press release relating to
plans, strategies, trends, specific activities or investments, and
other statements that are not descriptions of historical facts may
be forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking
information is inherently subject to risks and uncertainties, and
actual results could differ materially from those currently
anticipated due to a number of factors, which include risks
inherent in doing business, trends affecting the global economy,
including the devaluation of the RMB by China in August 2015 and
other risks detailed from time to time in CBMG’s reports filed with
the Securities and Exchange Commission, quarterly reports on form
10-Q, current reports on form 8-K and annual reports on form 10-K.
Forward-looking statements may be identified by terms such as
"may," "will," "expects," "plans," "intends," "estimates,"
"potential," or "continue," or similar terms or the negative of
these terms. Although CBMG believes the expectations reflected in
the forward-looking statements are reasonable, they cannot
guarantee that future results, levels of activity, performance or
achievements will be obtained. CBMG does not have any obligation to
update these forward-looking statements other than as required by
law.
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 347 481-3711
vivian.chen@grayling.com
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