- 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
Mesenchymal Stem Cells (MSCs)
Mesenchymal stem cells (MSCs) are a well-characterized population of adult stem cells that can differentiate into a variety of cell types (chondrocytes, osteoblasts, adipocytes, myocytes, and more).
Cynata Files New Patent Application for Cymerus™ Stem Cell Technology in Oncology
- Application filed with IP Australia would expand patent estate to immunotherapy
- Creates new opportunities in the growing field of immunotherapy and reinforces a position in oncology
RegMed’s First Xeno-Free Human Mesenchymal Stem Cell (MSC) Cell Banks
RoosterBio has announced the launch of the Regenerative Medicine (RM) industry’s first xeno-free (XF) hMSC cell banks to advance and simplify stem cell biomanufacturing. By incorporating XF starting materials at early stages, RM scientists can perform more clinically relevant work, resulting in an expedited path towards clinical testing programs. Due of the importance of this announcement, I followed up with Dr. Priya Baraniak, Director of BD & Strategic Marketing at RoosterBio, to further explore details of the launch. [Read more…]
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
Longeveron Begins Enrollment of Second Cohort of Phase 1 Alzheimer’s Disease Trial
MIAMI, May 10, 2017 — 
Longeveron, a regenerative medicine company, announced that their Phase 1 Alzheimer’s disease trial will proceed with enrollment at the recommendation of an independent Data Monitoring Committee (DMC) which reviewed data from the trial’s safety run-in phase.
The clinical trial is designed to assess the safety, tolerability and efficacy of intravenous infusion of two different doses of Longeveron mesenchymal stem cells (LMSCs) compared to placebo. The DMC reviewed safety data from a five-patient run-in phase where subjects diagnosed with Alzheimer’s disease were given a single infusion of either LMSCs or placebo. Longeveron now has the green light to continue the trial.
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