Welcome to your update from the clinic for the month of January. It was a quiet month in the clinic. However, we did see some clearances for various clinical studies, including Fate’s ProTmune in GvHD and Pluristem’s PLX-R18 in hematopoietic recovery following bone marrow transplant.
Pluristem (PSTM) continues to increase the breadth of applications for its placenta-based cell therapy platform, having been given a clearance by the Food and Drug Administration (FDA) to investigate its PLX-R18 cells in patients experiencing poor recovery of the blood system following bone marrow transplant. The multicentre, open label Phase 1 study will evaluate PLX-R18 in 30 patients who will receive the therapy via intramuscular injection. Preclinical work completed by PSTM and other medical centres shows that PLX-R18 cells express a number of proteins that are responsible for stimulating growth in hematopoietic progenitors.
Fate Therapeutics (FATE), received clearance from the FDA to advance its ProTmune product into the clinic for the treatment of graft versus host disease (GvHD) and infections arising from cytomegalovirus (CMV). ProTmune is an allogeneic, mobilized peripheral blood (mPB) product that is modified, or programmed, with two small molecules to promote immune tolerance. This assists in the prevention of GvHD in patients receiving bone marrow transplant with mPB. A multicentre, randomized, controlled Phase 1/2 study will be launched in mid-2016 in patients undergoing bone marrow transplant for hematological malignancy. Initially, 10 patients will be treated; following a safety review, a second tranche of 60 patients will be treated in the Phase 2 stage. While peripheral blood is a preferred source of stem cells for transplant due to the fact it is less invasive than bone marrow, it is associated with increased incidence of GvHD. ProTmune should help circumvent this issue.
Cytori Therapeutics (CYTX) provided an update on its randomized, placebo controlled, pivotal Phase 3 study investigating Cytori Cell Therapy (ECCS-50) in patients with scleroderma. ECCS-50 involves an injection of subcutaneous fat into the fingers of patients. Results from the pilot trial, published in 2015, showed no adverse events and significant improvements in hand function at one year post-treatment. CYTX enrolled its 20th patient in the pivotal trial. A safety review committee has recommended the trial continue after evaluation of the first 10 patients. CYTX also began enrollment of a Phase 2 study in patients with Crohn’s disease.
Last, but not least, Lion Biotechnologies (LION), which recently expanded its collaboration with the National Institutes of Health (NIH), submitted an Investigational New Drug (IND) application to begin studies in cervical, head and neck cancer. This will expand the clinical application of the company’s tumour-infiltrating lymphocyte (TIL) platform.
Disclaimer: “Update from the Clinic” is a blog post generated by news flow from public regenerative medicine (RM) companies around the globe. As CCRM has public RM companies in its industry consortium, and the number of such companies is relatively limited on a global scale, Mark Curtis will sometimes include CCRM consortium members in his review. This blog post is provided for general information only and nothing contained in the material constitutes a recommendation for the purchase or sale of any security. The author is not a shareholder of any public RM company. To see a list of CCRM’s industry consortium members, please visithttp://ccrm.ca/industry-consortium