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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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November 15, 2011

Geron, Stem-Cell Pioneers, Drop Stem Cells

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Posted by Derek

Are stem cells overhyped? That topic has come up around here several times. But there have been headlines and more headlines, and breathless reports of advances, some of which might be working out, and many of which are never heard from again. (This review, just out today, attempts to separate reality from hype).

Today brings a bit of disturbing news. Geron, a company long associated with stem cell research, the company that started the first US trial of embryonic stem cell therapy, has announced that they're exiting the field. Now, a lot of of this is sheer finances. They have a couple of oncology drugs in the clinic, and they need all the cash they have to try to get them through. But still, you wonder - if their stem cell trial had been going really well, wouldn't the company have gotten a lot more favorable publicity and opportunities for financing by announcing that? As things stand, we don't know anything about the results at all; Geron is looking for someone to take over the whole program.

As it happens, there's another stem-cell report today, from a study in the Lancet of work that was just presented at the AHA. This one involves injecting heart attack patients with cultured doses of their own cardiac stem cells, and it does seem to have helped. It's a good result, done in a well-controlled study, and could lead to something very useful. But we still have to see if the gains continue, what the side effects might be, whether there's any advantage to doing this over other cell-based therapies, and so on. That'll take a while, although this looks to be on the right track. But the headlines, as usual, are way out in front of what's really happening.

No, I continue to think that stem cells are a very worthy subject of research. But years, quite a few years, are going to be needed before treatments using them can become a reality. Oh, and billions of dollars, too - let's not forget that. . .

Comments (12) + TrackBacks (0) | Category: Biological News | Business and Markets | Cancer | Cardiovascular Disease | Press Coverage


COMMENTS

1. johnnyboy on November 15, 2011 10:16 AM writes...

"It's a good result, done in a well-controlled study"

It's 14 treated patients vs 7 untreated controls (not sham-treated), in an open-label study. The main finding is a relatively mild increase in LVEF in treated patients, with a rather large spread in values. And I notice that the authors use the SE to show the spread, even though the groups are of different sizes - either from complete ignorance of proper descriptive statistics, or from willful obfuscation, either way it shines a bad light on their level of objectivity.

I don't derive joy from pissing on bonfires, but this preliminary result seems to me very, very far from being considered a definitive positive result.

Permalink to Comment

2. stuff on November 15, 2011 10:42 AM writes...

I guess they were not helped by the massive delays at the regulator. Probably cost a lot of cash.

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3. emjeff on November 15, 2011 11:34 AM writes...

Using the SEM to conceal the variability in response is a time-honored way to make your data look better. I predict this therapy goes nowhere.

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4. anon 1 on November 15, 2011 4:04 PM writes...

I too continue to have hope, and agree with Derek that it will take years to see what might come of this area. But, one thing is almost certain, which is that all the initial hype won't be satisfied. There may be areas for which stem cells therapy will work very well, even may transform current treatments, but it will not br the solution to everything, anything.

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5. John on November 15, 2011 6:28 PM writes...

You've overlooked the promising work in ophthalmology. Around a dozen companies are chasing stem cells for retinitis pigmentosa, dry AMD, etc. Phase IIs for e.g. NT-501 were pretty good. I'd bet on years, not decades.

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6. anon 1 on November 15, 2011 10:48 PM writes...

5, John:

As you said, chasing. Many times phase 2 data is only a suggestion for hope, if even that depending on how the studies were conducted, and that the compound can have the possibility to be a potential clinically approved drug. I'll wait until data from two well-constructed and conducted Phase 3 studies becomes available for evaluation and review before declaring success.

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7. Vincent on November 15, 2011 11:58 PM writes...

Hi John
NT-501 is an encapsulated cell technology (ECT) implant that contains engineered RPE cells (not ES cells) expressing CNTF for RP and GA / dry AMD. Yes ECT is promising, unlike embryonic stem cell therapy.

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8. John on November 16, 2011 6:47 AM writes...

Hi Vincent,

I don't think I implied that NT-501 used ES cells. I'd call it a trophic stem cell therapy, so it fits the theme of this post. Interested to hear your thoughts on why embryonic is less promising, especially for regen.

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9. Vincent Ling on November 16, 2011 9:38 AM writes...

Hi John,
My first project in a biotech company was on in vitro differentiation of mouse ES cells / embryoid bodies, before there were human ES cell lines. Sure, one can add stuff to "direct" differentiation, and look at resultant cells that come out. However it became readily clear that it was extremely difficult to guide the differentiation reproducibly and discover new growth factors along the way. In fact there were only some labs that could differentiate ES cells efficiently and get published. It became clear to us lab rats (and the senior managment) that in vitro differentiation was a great research tool but was going to be so difficult to scale-up, let alone manufacture. The ES cell program was ditched after 2 years of work (prob. wasted $2 - $3M considering the # of people involved). Some of the people in the company left for Geron, actually. I've always seen the "promise" of hESC as hype, as compared to the decades of work on hematopoetic stem cells and bone marrow transplant.

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10. Tyrosine on November 17, 2011 11:08 PM writes...

"No, I continue to think that stem cells are a very worthy subject of research. But years, quite a few years, are going to be needed before treatments using them can become a reality."

Well that's not quite true. Bone marrow transplants to repopulate blood cells following chemotherapy or radiotherapy for blood-cancers has been successful for may years. A bone marrow transplant is simply hematopoietic stem cell therapy of course. It's not that the jury is out on whether stem cell treatments will ever become a reality, rather how long until the next one.

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11. Newton on January 5, 2012 9:40 PM writes...

Anyone has comments on BM-MSCs? Companies such as Osiris and Athersys seem to be doing well...

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12. Newton on January 5, 2012 9:43 PM writes...

particularly, what about the promise of using MSCs to treat GvHD and IBD?

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