MELBOURNE, Australia, Nov. 15, 2017Â — Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX:CYP), is pleased to provide an update on the progress of the clinical trial of its lead Cymerus™ mesenchymal stem cell (MSC) product CYP-001. [Read more…]
BioLife Solutions CryoStor® Cell Freeze Media Embedded in Cellular Biomedicine Group Clinical Trial of AlloJoin™
Off the Shelf Allogeneic Stem Cell Therapy for Knee Osteoarthritis
BOTHELL, Wash., Sept. 19, 2017 — BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media (“BioLife”), announced that Cellular Biomedicine Group (NASDAQ: CBMG), a leading clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases (“CBMG”), has validated BioLife’s proprietary CryoStor freeze media for use in CBMG’s planned US Phase I clinical trial of AlloJoin, an off the shelf allogeneic stem cell therapy for knee osteoarthritis.
Mike Rice, BioLife President & CEO, commented, “We are very pleased to support CBMG in their development and potential commercialization of AlloJoin. CBMG is the leading regenerative medicine company in China, with a robust clinical pipeline and high-quality, scalable manufacturing facilities.”
In addition to this product adoption by CBMG, CryoStor and HypoThermosol®, BioLife’s companion cell storage and shipping media, have been used in at least 250 regenerative medicine applications, including several late-stage clinical trials. BioLife’s customer base has grown to over 2,000 companies, universities and clinical centers in the regenerative medicine, drug discovery and biobanking markets. [Read more…]
Cynata Therapeutics GvHD Clinical Trial and Corporate Progress
- Patient dosing commenced in world-first Phase I trial of stem cell therapy CYP-001 in graft-versus-host disease; recruiting at six centres in the UK and Australia
- Secured $60-million-plus FUJIFILM partnership and license option for CYP-001 in GvHD
- Raised additional $10 million: $4 million equity investment from FUJIFILM and $6 million placement
- Reported positive pre-clinical data in heart attack and asthma; expanded pre-clinical pipeline to acute respiratory distress syndrome
- Filed two new patent applications with IP Australia to expand opportunities in cancer immunotherapy
- Completed pre-Investigational New Drug meeting with U.S. Food and Drug Administration Office of Cellular, Tissue and Gene Therapy; written recommendation expected by July 2017
Cynata Therapeutics Initiates Patient Treatment in World 1st Clinical Trial
In breaking news released earlier this month, Cynata Therapeutics (ASX: CYP) announced a major world first. The company treated a patient with steroid resistant acute graft-versus-host disease (GvHD) as part of a phase 1 clinical study of its first mesenchymal stem cell (MSC) product, CYP-001 .
This is an important value catalyst for Cynata and also for the regenerative medicine industry, because it is the first time ever that a patient has been treated with an allogeneic induced pluripotent stem cell (iPSC)-derived therapeutic mesenchymal stem cell (MSC) product.
Patient Treatment Commences in Cynata’s World First Clinical Trial (CYP-001)
- First patient with steroid resistant acute graft-versus-host disease (GvHD) treated in Cynata’s phase 1 clinical study of its mesenchymal stem cell (MSC) product, CYP-001
- World first clinical trial using a MSC therapeutic product derived from an induced pluripotent stem cell sourced from a single blood donation from one donor
- Transition into active clinical trials cements Cynata’s world leading position in the development and commercialisation of second generation stem cell products
- Partnership with Fujifilm for the commercialisation of CYP-001; trial commencement accelerates this target
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