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Pharmaceutical industry

FDA Clears Advanced Cell Technology's Investigational New Drug Application for Dry Age-Related Macular Degeneration Treatment

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application submitted by Advanced Cell Technology, Inc. (ACT) for the treatment of Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). This clears the path for a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degeneration, which afflicts between 10-15 million Americans.

Key Takeaways:

  • The FDA has cleared ACT's IND application for the treatment of Dry AMD using RPE cells derived from hESCs, marking a significant milestone in regenerative medicine.
  • The Phase I/II trial will enroll 12 patients at multiple clinical sites, including the Jules Stein Eye Institute at UCLA and the Ophthalmology Department at Stanford University School of Medicine.
  • The trial aims to determine the safety and tolerability of sub-retinal transplantation of RPE cells into patients with Dry AMD, with potential to slow or halt disease progression and restore visual acuity.
  • ACT's proprietary RPE cell manufacturing process is protected by broad patents, and the company plans to initiate a Phase I/II clinical trial for Stargardt's Disease concurrently.
  • The incidence of AMD is expected to double over the next 20 years, further exacerbating the unmet medical need for effective treatments.
  • ACT's clinical-grade hESC lines can generate a virtually unlimited and reproducible supply of healthy RPE cells, making treatment scalable and accessible.

Statistics:

  • 10-15 million Americans suffer from Dry AMD (Clinical Trials Research)
  • Dry AMD accounts for 90% of all Age-Related Macular Degeneration cases (Clinical Trials Research)
  • Over 10 million Europeans suffer from Age-Related Macular Degeneration (Edmund Mickunas, ACT's Vice President of Regulatory Affairs)
  • The incidence of AMD is expected to double over the next 20 years (Robert Lanza, MD, ACT's Chief Scientific Officer)
  • 50-200K RPE cells are needed to treat each patient, making manufacturing and distribution scalable (Robert Lanza, MD, ACT's Chief Scientific Officer)

Sources:

  • Advanced Cell Technology, Inc. (via PR Newswire)
  • Clinical Trials Week via NewsRx.com (2011)
  • Edmund Mickunas, ACT's Vice President of Regulatory Affairs
  • Robert Lanza, MD, ACT's Chief Scientific Officer

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