&2.29M to fund animal studies of therapy for knee osteoarthritis.
CUPERTINO, Calif, February 27, 2017 -- Cellular Biomedicine Group Inc. (CBMG) said the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, has awarded the company $2.29 million to support preclinical studies of AlloJoin, an "off-the-shelf allogeneic human adipose-derived mesenchymal stem cells for the treatment of knee osteoarthritis in the U.S.
While CBMG recently began two Phase 1 human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell acute lymphoblastic leukemia (ALL) and Refractory diffuse large b-cell lymphoma (DLBCL) as well as an ongoing Phase 1 trial in China for AlloJoin in knee osteoarthritis (KOA), this announcement represents CBMG's entrance into the U.S. for AlloJoin.
The money was granted under a CIRM initiative designed to speed development of stem cell treatments for people with unmet medical needs.
After the award, CIRM will be a more active partner with its recipients to further increase the likelihood of clinical success and help advance a preclinical applicant's research along a funding pipeline towards clinical trials.
CBMG's KOA preclinical program is considered late-stage, and therefore it meets CIRM 2.0's intent to accelerate support for clinical stage development for identified candidates of stem cell treatments that demonstrate scientific excellence.
The AlloJoin program has previously undergone extensive manufacturing development and preclinical studies and is undergoing a Phase 1 clinical trial in China.
To demonstrate comparability with cell banks previously produced in China for our U.S. IND filing, the company is addressing the preclinical answers required for the FDA.
With the funds provided by CIRM, the company will replicate and validate the manufacturing process and control system at the cGMP facility located at Children's Hospital Los Angeles to support the filing of an IND with the FDA.
The outcome of this grant will enable qualified final cell products ready to use in a Phase 1 clinical trial at the Keck School as a trial site.
CBMG recently announced promising interim 3-month safety data from its Phase 1 clinical trial in China for AlloJoin. The trial is on schedule to be completed by the third quarter of 2017.
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|Title Annotation:||Grants & Contracts|
|Publication:||Stem Cell Business News|
|Date:||Mar 6, 2017|
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