Cynata Therapeutics Ltd (ASX: CYP) is a clinical stage regenerative medicine company specializing in stem cell therapeutics that has a proprietary technology for manufacturing induced pluripotent stem cell (iPSC) derived mesenchymal stem cells (MSCs). Cynata is the only company in the world that can mass-produce therapeutic mesenchymal stem cells deriving from a single donor at a consistent quality and affordable cost. [Read more…]
Cynata’s iPSC-derived Cell Therapeutic
StemTek and Biopredic International partner to deliver assay ready liver models
Both companies plan to combine their respective technologies to deliver storable assay-ready 3D liver models for toxicology testing to reduce time and cost in new drug development.
August 21, 2018, Bilbao, Spain and Saint Grégoire, France — StemTek and Biopredic International are joining forces to design convenient, ready to use storable systems for toxicology screening on 3D liver cell models. 3D cell culture technology recapitulates the natural architecture of the tissue in a convenient laboratory format, producing more predictive data for in vivo tests. This technology allows a better understanding of the interaction of candidate compounds in areal physiological model, thus reducing drug failures. [Read more…]
FDA Awards Latest RMAT to Audentes Therapeutics for Gene Therapy Product AT132
On August 21, 2018, Audentes Therapeutics, Inc. (Nasdaq: BOLD ) announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to AT132, its treatment for X-linked Myotubular Myopathy (XLMTM).
Audentes is a biotechnology company that develops gene therapy products for patients for rare diseases.
Audentes has pursued a number of advanced regulatory pathways for AT132, including:
- Regenerative Medicine Advanced Therapy (RMAT), Rare Pediatric Disease, Fast Track and Orphan Drug designations by the FDA
- Priority Medicines (PRIME) and Orphan Drug designations by the European Medicines Agency (EMA)
Gradalis® Announces Initiation of Phase 3 Study of Vigil(TM) in Ewing’s sarcoma
– The open-label trial will measure progression free survival of participants from date of randomization until first disease progression in the study –
– The trial will use product produced from Gradalis’ recently-upgraded cGMP Carrollton facility –
DALLAS, August 28, 2018 — Gradalis, Inc., a clinical-stage immunotherapy company developing investigational treatments for individuals suffering from multiple cancer indications, today announced the initiation of its Phase 3 clinical trial of Vigil for individuals with Ewing’s sarcoma using product produced from Gradalis’ recently upgraded current Good Manufacturing Practice (cGMP) Carrollton facility. [Read more…]
Preliminary Results From BioCardia’s Phase III Pivotal CardiAMP Heart Failure Trial Reported In Circulation Research Journal
SAN CARLOS, Calif., Aug. 22, 2018 — In a Viewpoint paper published online today in Circulation Research, the Phase III CardiAMP Heart Failure Trial (CardiAMP-HF Trial) studying the investigational CardiAMP stem cell therapy from BioCardia®, Inc. (OTC: BCDA) was highlighted as an example of personalized medicine, with promising results from the first 10 patients in the roll-in cohort reported. The company believes this to be the first outcomes data published from any pivotal trial of a stem cell therapy for heart failure. The paper is authored by Peter Johnston, M.D., Eric Duckers, M.D., Ph.D., Amish Raval, M.D., Thomas Cook, Ph.D. and Carl Pepine, M.D. [Read more…]
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