Cellular Biomedicine Group Announces Three-Month Interim Safety Data from Phase I Clinical Trial for AlloJoinTM Off-the-Shelf Allogeneic Stem Cell Therapy for Knee Osteoarthritis
– No Serious Adverse Events Observed-
SHANGHAI, China and CUPERTINO, Calif., Dec. 9, 2016 /GlobeNewswire/- 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 AlloJoinTM 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 AlloJoinTM 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 ReJoinR, 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 AlloJoinTM for KOA under an IND in the United States.”
AlloJoinTM 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 AlloJoinTM 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:
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
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.
Director of Corporate Communications, CBMG
Managing Director Investor Relations, Citigate Dewe Rogerson
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