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Welcome to your Update from the Clinic for the month of January! We start the year off with the German health authority approving Pluristem’s next generation GMP cell manufacturing facility. Neuralstem successfully, and safely, transplants NSI-556 cells directly into the brain of its first patient in a Phase 1/2 study. Meanwhile, OncoMed and StemCells are in the news providing updates on their respective clinical programs. Read on to find out more.
Germany’s health authority, the Paul-Ehrlich-Institute (PEI), has given approval to Pluristem (PSTI) to provide cells for clinical studies from its brand new GMP facility that houses the company’s novel 3D bioreactor system. The platform is capable of producing commercial quantities of placenta-derived mesenchymal-like Adherent Stromal Cells (ASCs), which can be used to treat a variety of diseases. The German approval should provide a precedent for the U.S. Food and Drug Administration, to which Pluristem is currently seeking approval to provide clinical-grade cells within the U.S. The GMP facility is located in MATAM industrial park in Haifa, Isreal and will be able to produce 150,000 doses of ASCs annually.
Pluristem reported on positive safety and efficacy data from a Phase 1/2 study of its placenta–derived PLX-PAD cells in patients with muscle injury. The cells proved safe and the study achieved statistical significance in the measurement of the primary endpoint relative to placebo: change in voluntary muscle contraction force.
StemCells (STEM) transplanted its proprietary HuCNS-SC® neural stem cells for chronic spinal cord injury in its first North American patient. This transplant marks the 9th patient in the study, which began in Switzerland.
At the BaYi Brain Hospital in Beijing, China, Neuralstem (CUR) has successfully treated its first patient in a Phase 1/2 trial investigating NSI-556 in patients with motor deficits from ischemic stroke. The treatment approach is about as invasive as it gets – transplantation of cells directly into the brain – but the patient is safe at home after receiving the cells on December 27th. NSI-556 is a stem cell-based cell therapy derived from human spinal cord tissue. It is also being investigated in Lou Gehrig’s disease, otherwise known as amyotropic lateral sclerosis (AML). Incredible stuff.
OncoMed (OMED), a company developing therapeutics targeting cancer stem cells, has initiated the first of three Phase 1 studies investigating a first-in-class Wnt ‘decoy’ receptor, OMP-54F28, in patients with pancreatic cancer. The therapeutic is part of a combination therapy approach involving nab-paclitaxel and gemcitabine. The clinical research program is in collaboration with Bayer Pharma AG.
OncoMed is one of several companies that has surfaced over the last several years to go after “cancer stem cells” in the clinic. Others include Toronto-based Stem Cell Therapeutics (SSS), Massachusetts-based Verastem (VSTM) and New York-based Stemline Therapeutics (STML). OncoMed, Verastem and Stemline all had the momentum to execute IPOs, or initial public offerings, and go public off the back of the cancer stem cell theory, providing a strong indication the investment community is buying in. It will be interesting to see how these therapeutics fair in the clinic, and whether they really are capable of eradicating residual disease caused by tumour-sustaining subsets of cancer cells.