- 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."
- 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
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).
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
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
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