Last week, StemCells, Inc. received FDA authorization to expand its spinal cord injury trial to the United States.
The arrival of this Phase 1/2 study, which is currently ongoing in Switzerland and Canada and involves patients with chronic spinal cord injury, will significantly ease the travel burden for North American patients. Early results from the trial have been promising, showing two patients had gains in sensory function, first seen at 6 months and persisting 12 months after transplantation. No safety issues have been seen.
To date, seven patients from Germany, Norway, Italy, Israel, Canada and the United States have been transplanted at Balgrist University Hospital in Zurich. StemCells is now focused on opening up trial sites in the United States. Information about the clinical trial is available at the ClinicalTrials.gov website of the National Institutes of Health at http://www.clinicaltrials.gov/ct2/show/NCT01321333?lead=StemCells+Inc.&rank=4.
Russo Partners secured coverage of the announcement across industry publications, including Scrip, as well as regional publications, including the San Francisco Chronicle and the San Francisco Business Times. Read more about this announcement in the San Francisco Chronicle article below.
San Francisco Chronicle
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
Last week Cellular Dynamics International (CDI) and Life Technologies announced a partnership to commercialize a set of three novel products that are optimized to consistently develop and grow human induced pluripotent stem (iPS) cells for both research and bioproduction purposes. This partnership combines CDI’s leadership in human iPS cell development and manufacturing as well as Life Technologies’ expertise in the commercialization of stem cell research tools
By creating a consistent, defined reagent system, these products overcome the limitations associated with commonly-used stem cell culture products, such as bovine serum albumin (BSA) and lipids, by reducing the variability in results inherent with other reagents. Generating consistent performance supports the advancement of translational stem cell research and drug discovery efforts. These products also further research efforts by enabling large-scale production of human iPS cells to be conducted.
Recent studies published in Nature Methods and PLoS One validated the effectiveness of CDI’s products, and presentations by customers of studies using the company’s human iPS cells at the Society of Toxicology (SOT) Annual Meeting demonstrated the superiority of CDI’s products compared to other cell models.
In addition, CDI was named last year’s overall Gold winner in The Wall Street Journal Technology Innovation Awards based on the ability of its iPS cell manufacturing technology to facilitate understanding of human biology, improve the drug discovery process and develop cell-based therapies to treat human diseases.
Read more about The Wall Street Journal Technology Innovation Awards in the following article:
The Wall Street Journal
For the first time, a study by Advanced Cell Technology (“ACT”; OTCBB: ACTC)
Dr. Steven Schwartz, a retina specialist at the University of California, Los Angeles, conducted the trial with two patients. (Monica Almeida/The New York Times)
demonstrated the safety of the transplantation of human embryonic stem cells (hESC) derived from retinal pigment epithelium (RPE) into patients. Additionally, the injected cells survived and continued to persist during the study period. Results were reported for two patients, the first in each of the Phase 1/2 clinical trials, and were published in The Lancet, representing an important milestone for the field of embryonic stem cell research.
A patient said her vision improved in a meaningful way after the treatment, which used embryonic stem cells. (Monica Almeida/The New York Times)
In the study, patients with Stargardt’s macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD) were treated with ACT’s embryonic stem cell (ESC)-derived cells. Both patients were legally blind, and both had measurable improvements in their vision that persisted for more than four months. No treatments currently exist for either indication.
Through extensive media outreach coordinated by Russo Partners, coverage of this announcement was secured across all levels of print and broadcast media, including top tier, national, international, newswire, trade and regional outlets.
Below are links to samples of media coverage of the announcement:
New York Times
Los Angeles Times
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