Cellular Biomedicine Group Announces Interim Results From Phase IIb Clinical Trial for Knee Osteoarthritis Stem Cell ReJoin(T...
March 25 2015 - 9:00AM
Cellular Biomedicine Group Inc. (Nasdaq:CBMG) ("CBMG" or the
"Company"), a biomedicine firm engaged in the development of
effective treatments for degenerative and cancerous diseases, today
announced interim 24-week clinical data from the Phase IIb trial of
its ReJoinTM human adipose-derived mesenchymal progenitor cell
(haMPC) therapy for Knee Osteoarthritis (KOA). The data will be
discussed by Dr. Wei (William) Cao, PhD, BM, Chief Executive
Officer of Cellular Biomedicine Group at the 2015 Annual Regen Med
Investor Day at the Metropolitan Club in New York City.
Dr. Cao commented, "We are very pleased to see that the KOA IIb
interim data has confirmed observations from the Phase IIa trial
and change in WOMAC scores in the ReJoinTM treatment arm, the
primary endpoint of the Phase IIb trial, to be significantly higher
than the randomized control therapy group. We remain optimistic
about the efficacy of ReJoinTM treatment for KOA. With 57 million
KOA patients in China, this treatment represents an opportunity to
improve the quality of life for a meaningful number of
patients."
ReJoinTM Phase IIb 24-week Data Analysis
The 24-week interim data shows the primary and secondary
endpoints of ReJoinTM therapy group have all improved significantly
compared to their baseline, which has confirmed our Phase IIa
report (view report here), although only the change (47.12%) of
WOMAC, the primary endpoint, is significantly higher than that of
the ARTZÒ control group (16.32%) (p=0.017). A trend of improvement
of the secondary endpoints, including cartilage MRI quantification,
is observable at the 24th week. The Company expects the final
results to be available at the end of 2015.
About the Clinical Trial
The Phase IIb clinical research trial for KOA, registered with
the U.S. National Institutes of Health (NIH) under the number
NCT02162693 (click here to view), is led by Shanghai Renji
Hospital, one of the largest teaching hospitals in China. The
multi-center study enrolled 53 patients with knee osteoarthritis
(Kellgren-Lawrence Grading Scale: grade II-III) to participate in a
randomized, single blind trial.
The primary endpoints for the Phase IIb trial of ReJoinTM human
adipose-derived mesenchymal progenitor cell (haMPC) therapy for KOA
were safety and knee-related pain, stiffness and function measured
using the Western Ontario and McMaster Universities (WOMAC)
osteoarthritis index questionnaire. The secondary endpoints were
patient safety and cartilage repair during the 24 weeks post-cell
therapy, defined through changes of both knee joints' cartilage
volume measured with 3D SPGR quantitative magnetic resonance
imaging (MRI) and read with a semi-automated segmentation method
(ITK-SNAP) by three independent blind researchers, two of whom came
from two independent third party institutes. In addition, Visual
Analogue Scale Score (VAS), Short Form 36 and Lequesne Index of
Severity for OA (ISOA) index scores were employed to assess knee
pain, quality of life and joint function.
Further details of the clinical data may be viewed in the
Company's most recent presentation filed on Form 8-K with the SEC,
which can be found on the Company's website at the following link,
http://cellbiomedgroup.com/investor-relations/investment-overview/
under SEC filings or presentations.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell
therapies for the treatment of certain degenerative diseases and
cancers. Our developmental stem cell, progenitor cell, and immune
cell projects are the result of research and development by
scientists and doctors from China and the United States. Our
flagship GMP facility, consisting of eight independent cell
production lines, is 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, but are not
limited to, risk factors inherent in doing business.
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.
CONTACT: Sarah Kelly
Director of Corporate Communications, CBMG
+1 650 566-5064
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 347-481-3711
vivian.chen@grayling.com
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