BioTime’s Cell Cure Files IND with FDA for ES cell AMD therapy

Cell Cure LogoStem cell biotech BioTime announced the news today that its subsidiary Cell Cure Neurosciences (Cell Cure) has filed an IND with the FDA for an embryonic stem (ES) cell-based therapy for Dry age-related macular degeneration (AMD). The product to be tested is OpRegen, which the company indicates is “the first IND for an ES cell-based therapy developed in Israel.”

Cell Cure in its PR on this IND also listed three other key bullet points:

  • “IND filed for Phase I/IIa dose escalation trial in patients with dry-AMD
  • No approved therapy exists for dry-AMD, the leading cause of visual impairment in the aging population
  • OpRegen® will be the first preparation of xeno-free RPE cells to be evaluated clinically for dry-AMD”

I’m very curious to see how OpRegen performs in the trial.

This is only the third IND for an ES cell-based therapy with the other two coming from Advanced Cell Technology (ACT) and Geron.

I asked Dr. Mike West, CEO of BioTime, about the trial and he had this to say:

“Age-related degenerative diseases are really the frontier of medicine in our time. The aging of 76 million baby boomers and the consequent tsunami of healthcare costs associated with palliative as opposed to truly therapeutic care is a top national priority. I believe that AMD is only one of numerous examples where the stable engraftment of young healthy cells may provide important new therapeutics for these long-term and expensive problems of aging.”

Macular degeneration of various kinds is a focus of a number of pluripotent stem cell trials. For example, the first ever iPS cell-based clinical study, led by Masayo Takahashi, is also focusing on AMD.

Disclosure. I have no financial interests in BioTime or Cell Cure and have a small long position in ACT. This post is not financial advice.

2 thoughts on “BioTime’s Cell Cure Files IND with FDA for ES cell AMD therapy”

  1. Why does West run this under a different company from Asterias? Makes it very difficult to invest if you have to choose a Biotime company for each IND. Think I’ll stick with West’s original venture in ACT.

  2. Hi Paul – Indeed a good development for the nascent hESC field and a worthy runner in the Eye space.

    I’m keen to understand the product advantage here that Cell Cure brings to the field through their “Directed Differentiation” of RPEs via a Destructive Blastocyst ES cell versus an already 3 years ahead hESC RPE program by ACTC using an earlier state Non-Destructive Blastomere ES method. The added validation is welcome and another product in the mix an eventual plus for patients…

    A friendly update reminder on the current number of submitted/in-work hESC programs – don’t forget Viacyct and the French hESC Heart Patch Trail and the 2 Korean Eye programs – AMD & SMD, perhaps a 3rd in MMD (ACTC related).


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