Cellular Biomedicine Group Announces Three-Month Interim Safety Data from Phase I Clinical Trial for AlloJoin™ Off-the-She...
December 09 2016 - 8:00AM
- No Serious Adverse Events
Observed-
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a clinical-stage biomedicine firm engaged in the
development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, today announced interim
3-month safety data from its Phase I clinical trial in China for
AlloJoin™ off-the-shelf allogeneic stem cell therapy for Knee
Osteoarthritis (KOA). The preliminary data was presented on
December 8th at the World Stem Cell Summit in West Palm Beach,
Florida. The interim analysis of the trial has preliminarily
demonstrated a safety and tolerability profile of AlloJoin™ in
the three doses tested, and adverse events (AE) are similar to that
of the Company’s prior autologous trials. No serious adverse events
(SAE) have been observed. The trial is on schedule to be
completed by the third quarter of 2017.
“We are very pleased with the results of the
trial in China thus far and we look forward to the full data
readout including symptom and disease modification efficacy
measurements at the 6 month and 12 month time points,” said Dr.
Richard Wang, Chief Operating Officer of Cellular Biomedicine
Group, and GM of the Stem Cell Therapy Business Unit. “The
preliminary results of the CBMG proprietary allogeneic stem cell
technology have encouraged us to continue to explore clinical
safety and efficacy of the therapy in patients with Knee
Osteoarthritis, to reproduce the positive cartilage regeneration
results observed in our autologous trials with ReJoin®, and to
apply for late phase registration trials to potentially launch the
first disease modification therapy for KOA. The development of an
allogeneic product could increase the number of patients that can
be treated by manufactured haMPCs from a single healthy donor as an
off-the-shelf treatment, allowing for ease of manufacturing and
clinical use at a much lower cost. We continue to evaluate the
feasibility of initiating a clinical study of AlloJoin™ for
KOA under an IND in the United States."
AlloJoin™ Phase I 12-week Preliminary Safety Data
Summary
- Because subjects are still blinded, there is no break-down
information available for the three dosing groups
- No SAEs have been observed for any patients in the trial
(similar to the Company’s autologous trials)
- The most common AEs are knee pain and swelling after injection
- The severity of AE is similar to that of the Company’s
autologous trials (mild to moderate)
- The occurrence appears different from the Company’s autologous
trials; more patients reported pain (77% vs. 50%) and less reported
swelling (54% vs. 72%)
- The Company will report further safety data and efficacy data
at the 6-month and 12-month periods
About the Clinical Trial The Phase I study of
AlloJoin™ for KOA is led by 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 Institutional Review
Board (IRB)-approved study enrolled 18 patients with knee
osteoarthritis (Kellgren-Lawrence Grading Scale: grade II-III) to
participate in the randomized, double blinded trial. The patients
received two dose intra-articular injections at three-week
intervals.
The primary endpoint for this trial is safety
after cell therapy. The secondary endpoints are knee-related pain,
stiffness and function measured using the Western Ontario and
McMaster Universities (WOMAC) osteoarthritis index questionnaire
and cartilage repair/regeneration post cell therapy, defined
through changes of both knee joints’ cartilage volume measured with
3D spoiled gradient-recalled echo (SPGR) quantitative magnetic
resonance imaging (MRI) and read with a semi-automated segmentation
method (ITK-SNAP). A number of biomarkers and their changes in
response to the therapy will also be studied as exploratory end
points. The trial is registered with the U.S. National Institutes
of Health (NIH) under the number NCT02641860 (click here to
view).
An archived presentation is available on the Company website
here:
http://www.cellbiomedgroup.com/investor-relations/presentations/.
About Cellular Biomedicine Group
(CBMG)Cellular Biomedicine Group, Inc. develops
proprietary cell therapies for the treatment of cancer and
degenerative diseases. Our immuno-oncology and stem cell projects
are the result of research and development by CBMG’s scientists and
clinicians from both China and the United States. 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. To learn more about CBMG, please visit:
www.cellbiomedgroup.com
Forward-Looking
StatementsStatements 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.
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Citigate Dewe Rogerson
+1 347 481-3711
vivian.chen@citigatedr.com
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