Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a clinical-stage biopharmaceutical firm engaged in the
development of immunotherapies for cancer and stem cell therapies
for degenerative diseases, today announces 48-week clinical data
from the Phase I clinical trial in China for its allogeneic
adipose-derived mesenchymal progenitor cell off-the-shelf therapy
AlloJoin™ for Knee Osteoarthritis (KOA). The data was
presented on March 16, 2018 at the B. Riley FBR Inaugural China
Healthcare Investing & Partnering Symposium (CHIPS) conference
in Hangzhou, China, by Dr. ChengXiang (Chase) Dai, General Manager
of the Company’s Stem Cell Business Unit.
“We are very
encouraged by the latest data from
our AlloJoin™ Phase I trial in China which
demonstrates good safety and early efficacy for the prevention of
cartilage deterioration. The recent regulatory guidelines
issued by the CFDA have set a clearer clinical and
commercialization pathway for our AlloJoin™ platform.
The success of the trial thus far, targeting
an addressable market of 57 million KOA patients in
China, prompted us to realign our resources
to better focus on the China market. We believe
developing our KOA therapies in China is a faster path to market at
a fraction of the cost of conducting US trials,” said Tony (Bizuo)
Liu, CEO for the Company. “In that light, we
are de-prioritizing the
U.S. AlloJoin™ operation and the California
Institute of Regenerative Medicine (CIRM) project has been
terminated, effective March 14,
2018. The two AlloJoin™ cell banks, which we
have created in the U.S, will now be stored in our Maryland
facility for future use. We will continue to advance in China
both our stem cell and CAR-T platforms as each becomes more widely
approved.”
AlloJoin™ Phase I 48-week Data
AnalysisThe 48-week analysis of study data of 22 patients
demonstrated AlloJoin™ off-the-shelf allogeneic stem cell
therapy for KOA to have good safety tolerance and early signs of
efficacy in preventing cartilage deterioration. The total WOMAC
scores (consisting of pain, stiffness and function scores of
joints) as a primary end point showed a significant improvement at
12 weeks post AlloJoin™ cell therapy and continued improvement
at 48 weeks. The secondary evaluation end point, the data of 3D
spoiled gradient-recalled echo (SPGR) quantitative magnetic
resonance imaging (MRI) for whole knee cartilage volume at 48 weeks
showed an increased tendency when compared with that at baseline 0
weeks, and as compared with normal cartilage deterioration as a
result of aging.
The presentation with detailed data can be
viewed on the Company website under the Investor section.
“The analysis of this early stage clinical study
has indicated a good safety and potential efficacy for an
off-the-shelf allogeneic haMPC therapy, which would allow us to
continue to advance clinical trials to confirm efficacy of such
cell therapy in preventing cartilage deterioration. The Company
believes that the opportunity for patients to prevent further knee
cartilage degeneration and improve the long-term quality of life
using stem cells could be preferable to undergoing drug treatment
with adverse side effects or painful and invasive knee replacement
surgery. If this allogeneic cell therapy, which takes less time and
cost to produce as compared to autologous therapies, would be
proved effective and approved for clinical use, then 57 million
symptomatic KOA patients in China may have access to a more hopeful
therapy, which could stop or delay cartilage deterioration and also
improve joint pain, stiffness and movement function,” commented Dr.
ChengXiang (Chase) Dai, General Manager, Stem Cell Business Unit of
CBMG.
Common side effects were temporary local
reactions including soreness and swelling at the injection site and
negligible systemic reactions, except one patient that reported
transient dizziness after inter-articular injection of AlloJoin™.
Two patients who underwent one dose of injections dropped out of
the study as they reported their knee joints were more painful
after injection. To date, no serious adverse events (SAE) related
to AlloJoin™ therapy have been reported.
About the AlloJoin™ Clinical
Trial The Phase I clinical research trial for AlloJoin™,
registered at ClinicalTrials.gov under the number NCT02641860, is
conducted in China at Shanghai Renji Hospital, one of the largest
teaching hospitals in China, with Principal Investigator Chunde
Bao, MD, Professor of Medicine, Vice Chairman of the
Chinese Rheumatology Association. The single-center study
enrolled 22 patients with knee osteoarthritis (Kellgren-Lawrence
Grading Scale: grade II-III) to participate in a randomized,
double-blind trial with three different cell dose groups.
The primary endpoints for this trial 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 cartilage repair
at 12 months by assessment of changes of the knee joint cartilage’s
volume measured with 3D SPGR quantitative MRI, in addition to VAS,
SF-36 and Whole-Organ Magnetic Resonance Imaging Score (WORMS)
scores.
Of the 22 patients enrolled, 20 patients
underwent two doses of intra-articular injections of
AlloJoin™ at 3-week intervals. All 20 of those
patients were followed up and evaluated for safety and efficacy at
4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Nineteen of the 22 patients were evaluated by third-party
quantitative MRI assessment of the whole joint cartilage volume at
baseline and 48 weeks. The Company has completed data management
and statistics analysis via third-party statistics unit, Department
of Health Statistics, Public Health College, Fudan
University.
About Cellular Biomedicine
Group Cellular Biomedicine Group, Inc. (NASDAQ:CBMG)
develops proprietary cell therapies for the treatment of cancer and
degenerative diseases. We conduct immuno-oncology and stem cell
clinical trials in China using products from our integrated GMP
laboratory. Our GMP facilities in China, consisting of twelve
independent cell production lines, are designed and managed
according to both China and U.S. GMP standards. Our Shanghai
facility includes a ”Joint Laboratory of Cell Therapy” with GE
Healthcare and a “Joint Cell Therapy Technology Innovation and
Application Center” with Thermo Fisher Scientific, which
partnerships focus on improving manufacturing processes for cell
therapies. CBMG currently has ongoing CAR-T Phase I clinical trials
in China; CARD-1 for Diffuse Large B-cell Lymphoma (DLBCL) and
Non-Hodgkin Lymphoma (NHL) and CALL-1 for adult Acute Lymphoblastic
Leukemia (ALL), utilizing CBMG’s proprietary and optimized CD19
construct, a Phase IIb trial in China for Rejoin™ autologous
Human Adipose-derived Mesenchymal Progenitor Cell (haMPC) for the
treatment of Knee Osteoarthritis (KOA) as well as a Phase I trial
in China for AlloJoin™ (CBMG’s “Off-the-Shelf” haMPC) for the
treatment of KOA. In Q1 2018 CBMG was added to the Loncar China
BioPharma index. 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 and 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 those
regarding our ability to implement our plans, strategies and
objectives for future operations, including our plan to configure
part of our Shanghai facility with GE Healthcare’s FlexFactory
platform, our ability to execute on proposed new products, services
or development thereof, results of our clinical research and
development, regulatory infrastructure governing cell therapy and
cellular biopharmaceuticals, our ability to enter into agreements
with any necessary manufacturing, marketing and/or distribution
partners for purposes of commercialization, our ability to seek
intellectual property rights for our product candidates,
competition in the industry in which we operate, overall market
conditions, any statements or assumptions underlying any of the
foregoing 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.
Contacts: Sarah Kelly
Director of Corporate Communications, CBMG+1 650 566-5064
sarah.kelly@cellbiomedgroup.com
Cellular Biomedicine (NASDAQ:CBMG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cellular Biomedicine (NASDAQ:CBMG)
Historical Stock Chart
From Apr 2023 to Apr 2024