Significant recent events include:
• In September 2009, StemCells announced the publication of preclinical data demonstrating the therapeutic potential of its HuCNS-SC ® product candidate (purified human neural stem cells) in neuronal ceroid lipofuscinosis (NCL), often referred to as Batten disease, a fatal neurodegenerative disorder in children. The Company’s neural stem cells, when transplanted in a mouse model of infantile NCL, were shown to engraft, migrate throughout the brain and continuously secrete the missing lysosomal enzyme characteristic of NCL. Moreover, mice that received the transplanted cells showed statistically significant reduction in cellular waste build-up, protection of critical host neurons and delayed loss of motor function compared with the control (non-transplanted) group. This data was published in the peer-reviewed journal Cell Stem Cell. The Company completed a Phase I clinical trial in NCL in January 2009, which demonstrated a favorable safety profile of the HuCNS-SC cells and the transplantation procedure.
• In September 2009, StemCells announced plans to initiate a Phase I trial of its HuCNS-SC cells in patients with Pelizaeus-Merzbacher Disease (PMD), a fatal myelination disorder that primarily affects infants and young children. This trial will be the first ever clinical trial of neural stem cells in a myelination disorder, and will be the Company’s second clinical trial of its HuCNS-SC cells. The trial will be conducted at the University of California, San Francisco (UCSF) Children’s Hospital.
• In September 2009, StemCells announced organizational initiatives focused on growing its SC Proven cell culture products business and advancing the development and commercialization of its cell-based assay platforms for use in drug screening and drug development. These initiatives included new personnel appointments and a realignment of activities within the Company’s Cambridge, UK and Palo Alto, California locations to more effectively leverage the Company’s cell-based technology platforms and expertise. StemCells also announced that it had completed the wind-down of its operations in Melbourne, Australia.
• In October 2009, StemCells announced new preclinical data showing that its human neural stem cells protect cone photoreceptors (cones) from progressive degeneration and preserve visual function long term. Cones are light sensing cells that are highly concentrated within the macula of the human eye, and the ability to protect these cells suggests a promising approach to treating age-related macular degeneration (AMD), the leading cause of vision loss and blindness in people over the age of 55. These important findings were presented at the Society for Neuroscience 2009 Annual Meeting.
“This is our second quarter consolidating the SCS operations, and some of the benefits of the combination are beginning to materialize,” said Martin McGlynn, president and CEO of StemCells, Inc. “Product sales from our SC Proven cell culture business are growing rapidly and we anticipate our first post-acquisition new cell culture media product launch early next year. We have also realigned resources to accelerate the development of cell-based drug discovery and drug development tools for the pharmaceutical industry, and reaffirmed our participation in NEUROscreen, a European Union-funded research consortium that seeks to advance the use of cell-based technologies to screen potential drug candidates for neurological disorders.
“We also continue to make progress in our therapeutic product development programs. We anticipate initiating our PMD trial at UCSF by year-end, and are excited about our HuCNS-SC product entering the clinic in a second indication. Additionally, we will meet with the FDA this month to discuss the results of our Phase I NCL trial and the potential pathway for this indication, and, based on the promising results reported this past quarter, we are pushing ahead with preclinical development for AMD and other retinal disorders.”
About StemCells, Inc.
StemCells, Inc. is focused on the development and commercialization of cell-based technologies. In its cellular medicine programs, StemCells is targeting diseases of the central nervous system and liver. StemCells’ lead product candidate, HuCNS-SC ® cells (purified human neural stem cells), is in clinical development for the treatment of two fatal neurodegenerative disorders that primarily affect young children. StemCells also markets specialty cell culture media products under the brand SC Proven ® , and is developing its cell-based technologies for use in drug screening and drug development.[b] The Company has exclusive rights to approximately 55 issued or allowed U.S. patents and approximately 200 granted or allowed non-U.S. patents. [/b] Further information about StemCells is available at www.stemcellsinc.com .
$1.6 (10/20/09)
