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.

Has anti-aging finally come of age with Google’s Calico?

Can Google’s new anti-aging company, Calico, have you Googling at age 140?

Don’t sell your burial plot just yet.

Stem Cells Aging

The idea of anti-aging has been around for a very long time and efforts to combat aging have spanned millennia largely without any success so Calico (apparently short for California Life Company, which sounds more like an insurance company to me) faces long odds. Note too that Calico cats are not known for any particular predisposition to long life. Hmmm.

At the same time, Calico means business and has hired some truly stellar talent in the research world including CEO Arthur Levinson, Cynthia Kenyon, David Botstein, Hal Harron, and Robert Cohen.

This is not a group you say “impossible” to lightly even on a topic as tough as anti-aging.

Still I don’t see any particularly clear pathway forward toward significant extension of human life expectancy.

Perhaps they have a more creative vision? We’ll see. I hope so!

Oddly enough a best as I can tell, Calico has no website at the present time. What the heck?

I’m currently reading a great book by author Stephen S. Hall called “Merchants of Immortality“. I’d highly recommend that the Calico crew read it if they haven’t already. BTW, the subtitle is an apt warning of sorts: “Chasing the Dream of Human Life Extension”.

The book features many companies and scientists who have been interested in anti-aging including BioTime CEO, Michael West, who founded the company Geron at least in part with the vision to battle aging.

Of course any discussion of aging should also feature stem cells. So another book that I recommend to Calico folks is my new book, Stem Cells: An Insider’s Guide.

In it, I propose a new theory of aging in which the number of healthy stem cells that we each possess directly correlates with our biological age. I also propose the notion that for many people their death certificates should read for the cause of death “ran out of stem cells”. In my book I have many illustrations including a great one on aging conceived by me and created by scientific illustrator Taylor Seamount (see image above).

The tricky part about human life extension and anti-aging is that I’m not convinced that we (A) know what aging really means and (B) have the tools to do anything meaningful about it.

One must also factor in quality of life as well.

I hope that Calico changes our whole concept of aging and extends healthy life years for us all, but I have to admit I’m skeptical. The Fountain of Youth has proven elusive and most gains in human life expectancy have been indirect consequences of better nutrition and anti-infectious disease efforts.

If you are very interested in anti-aging, you might consider going to the A4M anti-aging conference in mid-December in Vegas. Should be quite the show.

You can roll the dice literally for cash and perhaps figuratively on living longer. You might bump into Google CEO Larry Page (a young 40 years old), former Cali Guv Schwarzenegger, Suzanne Somers, and other celebs who are preoccupied with anti-aging stuff.

Damn, I don’t see Dr. Oz on the agenda…. If you guys go I’d love to know your impressions.

A version of this piece was first published on Huffington Post.