This week, StemCells announced the publication of clinical and preclinical data in Science Translational Medicine with implications for treating myelination disorders, including multiple sclerosis, cerebral palsy and spinal cord injury.
In the clinical study, all four patients with a rare disease, Pelizaeus-Merzbacher disease (PMD), demonstrated creation of myelin, which has never before been demonstrated. Three of the four patients showed modest gains in their neurological function, and the fourth remained stable. It is important to note that this Phase 1 study did not contain a control arm, so further studies must be conducted.
A preclinical study that demonstrated the production of myelin in an animal model of severe myelin deficiency was simultaneously published and provided the rationale for the PMD clinical trial and further supports the company’s approach for treating other myelination disorders.
Read more about the study and results in the article below from WebMD.
This week, StemCells presented the first data demonstrating gains in sensory function of chronic spinal cord injury patients treated with stem cells. These improvements were seen in two of the three patients in the first cohort of the Phase I/II study after six months of treatment, with the third patient remaining stable. These patients had the most severe injury, leaving them initially with no neurological function below the level of injury.
These gains in sensory function were measured by electrical impulse transmission across the site of injury during different tests of sensory perception, including a touch test, pin prick test and heat perception test. StemCells is focused on enrolling the next cohort of patients that have incomplete spinal cord injury.
The data were presented by Armin Curt, M.D., principal investigator for the clinical trial, at the 51st Annual Scientific Meeting of the International Spinal Cord Society in London.
StemCells is also evaluating its human neural stem cells in clinical trials of other neurological disorders, including Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder, and dry age-related macular degeneration (AMD). In addition, the company announced this week that it was awarded $20 million in funding from the California Institute for Regenerative Medicine (CIRM) to advance its preclinical Alzheimer’s program through IND-enabling activities.
Russo Partners worked to secure coverage of the data announcement across UK-based publications including The Telegraph; top-tier outlets including CNN and CBSNews.com; newswires including Reuters; science-focused publications including New Scientist; and regional publications including the San Francisco Business Times.
Read more about the results and a patient involved in the study in the articles below from CNN and The Telegraph:
Last week, StemCells was awarded $20 million from the California Institute for Regenerative Medicine (CIRM) to fund preclinical development of the company’s human neural stem cells as a potential treatment for cervical spinal cord injury. In sum, the agency awarded over $150 million to promising stem cell therapeutics, with StemCells being the only company to receive an award.
Disease advocates speak on July 26, 2012, in Burlingame, Calif., where the California Institute for Regenerative Medicine decided whether to approve more than $100 million in funding. Photo: Liz Hafalia, The Chronicle / SF
Funds from this award will be applied over a four-year period, with the goal of filing an investigational new drug (IND) application in that time. Currently, StemCells is evaluating the same neural stem cells in a Phase 1/2 clinical trial in chronic spinal cord injury, a Phase 1 clinical trial in a rare myelination disorder, Pelizaeus-Merzbacher disease (PMD), which holds applications for multiple sclerosis and cerebral palsy, as well as a Phase 1 trial in dry age-related macular degeneration (AMD).
A decision on an Alzheimer’s disease application submitted by the company was deferred to CIRM’s Grants Working Group for further consideration, and is expected to be reviewed at the next meeting of its governing board currently scheduled for September 6th.
Read more about the StemCells’ award as well as other projects funded by CIRM in the article below from the San Francisco Chronicle.
San Francisco Chronicle