Cellular Biomedicine Group Announces Positive 48-Week Data From Phase IIb Clinical Trial for Knee Osteoarthritis Stem Cell ReJoin® Therapy
SHANGHAI, China and CUPERTINO, Calif., Jan. 13, 2016 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced positive 48-week clinical data from the Phase IIb trial of its human adipose-derived mesenchymal progenitor cell (haMPC) therapy ReJoin® for Knee Osteoarthritis (KOA). The data was presented January 12th at the 8th Annual BioTech Showcase investor conference held in San Francisco, CA.
The Company continues to be encouraged by the latest data from its ReJoin® trials. Objective measurement of cartilage volume by 3D SPGR quantitative magnetic resonance imaging (MRI) indicated significant increase of cartilage volume following ReJoin® therapy, as opposed to further cartilage deterioration normally found in untreated patients1. The Company believes that the opportunity for patients to regenerate their damaged knee cartilage and improve the long-term quality of life using their own stem cells could be more preferable than undergoing drug treatment with adverse side effects or painful and invasive knee replacement surgery or other invasive surgical procedures. The positive preliminary results from these trials bring the Company closer to commercialization of ReJoin® therapy in China, where there are more than 57 million KOA patients with no approved KOA treatment for structure modification available.
ReJoin® Phase IIb 48-week Data Analysis
The 48-week end of study data of 53 patients shows the primary and secondary endpoints of ReJoin® therapy group having all improved significantly compared to their baseline, which has confirmed some of the Company's Phase I/IIa results (view report here). The total WOMAC scores (consisting of pain, stiffness and function scores of joints) as a primary end point show statistical treatment significance at week 48 compared to the baseline. The total knee cartilage volume change measured by a semi-automated segmentation method (ITK-SNAP) by two different blinded researchers show significant gain of cartilage in the ReJoin® group but a loss of cartilage in ARTZ@ group, reaching statistical difference between the two groups 48 weeks after therapy.
Highlights of the full 48-week follow-up data:
- Western Ontario and McMaster Universities Arthritis Index (WOMAC): significantly decreased by 9.48 (28.52% improvement rate) in the ReJoin® group and by 6.92 (20.74% improvement rate) in the ARTZ@ control group at week 48, but there is no significant difference between the two groups. Subset analysis of subject numbers with WOMAC improvement rate ≥ 50% and ≥ 70% showed significant differences of ReJoin® group over the ARTZ@ group at 48th week after therapy (p=0.0038 and 0.0388, respectively).
- 3D Spoiled Gradient-Recalled Echo (SPGR) MRI Quantitative Assessment: The cartilage volume of both knees together increased significantly by 302.06 mm3 in the ReJoin® group but decreased by 125.35 mm3 in ARTZ@ group at 48 week time point after therapy, reaching high statistical difference (p=0.0007).
- Visual Analog Scale (VAS): Pain relief indices as measured by VAS for the left and right knees show continued improvement at 48 week (46.51% and 47.89%) compared to 24 week (42.21% and 40.39%) over the baselines in the ReJoin® group. The control ARTZ@ group has the scores of 16.47% and 10.82% at 48 week, 19.59% and 14.77% at 24 week, respectively. At both time points there were statistically and significantly better effects observed for ReJoin® treatment over the ARTZ® control group.
- Short Form Health Survey (SF-36): The quality of life endpoint measured by SF-36 questionnaire also shows statistical improvement from the baseline at week 48 by 9.39 and week 24 by 8.30 of the ReJoin® group over the ARTZ® control (3.92 and 3.38, respectively), with P value of 0.010 and 0.034.
- No serious adverse events reported to date.
About the ReJoin® Phase IIb trial for KOA
The Phase IIb is a randomized, double-blinded to patients and evaluators, and controlled trial, which enrolled 53 patients in multiple clinical centers with a 48-week follow-up duration. The endpoints were WOMAC score, VAS score, SF-36 score and MRI cartilage volume. The trial is conducted in China and registered with the U.S. National Institutes of Health (NIH) under the number NCT02162693 (click here to view).
About the ReJoin® Therapy
Cellular Biomedicine Group's ReJoin® therapy for KOA is an interventional therapy that consists of 30ml of adipose (fat) tissue obtained via lipoaspiration from the patient, from which the patient's vascular stromal cells (VSC; a combination of several types of monocytes including mesenchymal stem cells) are isolated using CBMG's proprietary medical device, the A-StromalTM Kit, which produces a high yield of VSC, and haMPCs are then expanded using CBMG's proprietary culture medium, and formulated for ReJoin® therapy using CBMG's proprietary formulation. After three weeks of cell culture there is an initial injection into the knee joints and a second injection three weeks later. The rest of the patient's haMPC are banked for potential future use.
Some of the special characteristics of ReJoin® regenerative therapy for KOA are:
- Autologous – patient's own cells
- No potential of immune rejection
- Readily available, easy to source via minimally invasive lipoaspirate, only 30ml of adipose (fat) tissue required
- Unlimited supply of patient's own cells from one lipoaspirate
- Significant results, including cartilage regrowth, in as early as 12 weeks, over the baseline from previous Phase I/IIa study, and confirmed superiority over the control at 48 weeks in the Phase IIb trial
- Relatively quick recovery compared to knee replacement surgery
- Potential long term therapeutic effects
- No serious adverse events reported to date, from the Phase I, Phase IIa and Phase IIb clinical trials
Further details of the clinical data may be viewed on the Company's website at the following link: http://www.cellbiomedgroup.com/investor-relations/presentations/
- BMC Musculoskelet Disord. 2011 Aug 24;12:195. doi: 10.1186/1471-2474-12-195.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative and cancerous diseases. Our developmental stem cell and Immuno-Oncology projects are the result of research and development by scientists and doctors from China and the United States. Our GMP facilities in China, consisting of nine independent cell production lines, are designed, certified and managed according to U.S. 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.