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Another Milestone, 2 Broad Patents Covering Use of Stem Cell-Derived RPE Cells, Advanced Cell Technology (OTCBB: ACTC)

ACTC will be issued US Patent Numbers 7,795,025 and 7,794,704 on 9/14/10, which continue to extend ACT’s patent portfolio covering its retinal pigment epithelial (RPE) cell programs.In particular, the claims that will issue in patent number 7,794,704 broadly cover methods for treating retinal degeneration using human RPE cells differentiated from human embryonic stem cells (hESCs).

  • Issued with 68 claims, this patent covers methods of treatment with hESC-derived RPE cells that includes, but is not limited to, Stargardt’s disease, Retinitis Pigmentosa, and macular degeneration,
  • The 41 claims issuing in US Patent 7,795,025 contribute to the development of the company’s protection of the processes for manufacturing RPE cells from human ES cells,
  • The patent covers fundamental methods for generating transplantable cells for treatment of human patients.

Another milestone for ACT…

  • “ACT is developing first-in-class treatments for degenerative disorders of the retina,” said Robert Lanza, M.D., ACT’s Chief Scientific Officer. “The use of RPE cells created from human embryonic stem cells should open the door to potential treatments for many diseases of the retina that impact sight. According to the World Health Organization, macular degeneration alone is known to affect 30-40 M people worldwide, and this represents only a handful of the 200 diseases that may be treated using our RPE cells. ACT has worked hard to develop an efficient method for producing a renewable source of transplantable RPE cells that can be used to target diseases such as Stargardt’s Disease and Age-related Macular Degeneration. For many of these patients there are no available treatments. ACT has demonstrated that stem cell-derived RPE cells can rescue visual function in animals that otherwise would have gone blind.

This IP further expands ACTC.OB’s patent estate with respect to protecting the use of RPE cells in a wide range of treatments, offering additional validation of the strength and breadth of its patent portfolio.

  • This development also dovetails nicely with the prospect of initiating human clinical trial for the RPE program,
  • ACT is optimistic that the methods-of-treatments and the culturing processes covered by these 2 new patents, along with ACT’s proprietary detection technique for final product release, will establish a formidable barrier to entry for any potential competitors,
  • Once ACT begins to treat Stargardt patients, ACT plans to initiate another clinical trial relating to the use of RPE cells in the treatment of dry Age-Related Macular Degeneration (NASDAQ:AMD),
  • At present there is no approved treatment for dry AMD, despite the fact that it represents a $20-30B  potential market.”
  • ACT’s Single Blastomere technology used for isolating hESCs does not require the destruction of embryos.

The RPE and other hESC-derived cells, ACTC.OB intends to produce for clinical use all begin with these “embryo-safe” stem cells.

  • ACT does not rely on government funding for any of its R&D efforts, and accordingly has not been impacted by the recent court injunction against federal funding of hESC research,
  • Nevertheless, ACT’s hESC lines and cells made for those lines (such as RPE cells) should (?) fall outside the scope of the court order,
  •  While the injunction has been stayed, it is widely believed that this is only a temporary reprieve, with a permanent injunction a real possibility perhaps as early as the end of this month,
  • Should that come to pass, ACT stands ready to offer its human stem cell lines to the research community, pending their approval by the National Institutes of Health (NIH).