Out of nowhere Geron Corporation announced last week it was not only halting the first clinical trial of embryonic stem cell treatment on humans but getting out of the embryonic stem cell business altogether.
To understand how big a blow to the embryonic stem cell industry this was, you first must know it was Geron that funded the University of Wisconsin Madison’s original research back in 1995, which resulted in the first cultures of embryonic stem cells. It was Geron that started this whole mess.
Geron went on to comprise one-third of the triune that controlled which company or university got access to embryonic stem cell lines, along with the Wisconsin Alumni Research Foundation and the National Institutes of Health.
In its position of power Geron grabbed the “exclusive commercialization rights” to the three most lucrative areas of embryonic stem cell research if treatments are ever found – spinal cord injury, heart disease, and diabetes.
Geron’s juggernaut culminated last year with the FDA’s first approval of embryonic stem cell treatment on human spinal cord injured patients, “triggering a wave of ebullience from scientists, investors and patient advocates,” according to the California Stem Cell Report.
Embryonic stem cell supporters were giddy with hope that Geron would find something, anything, to fulfill the “promise” of embryonic stem cell research.
Former Geron CEO Thomas Okarma (pictured left) only fueled that hope by boasting Geron stock shares would likely soar to “biblical proportions” if its spinal injury research was successful, in which case, he said, “the company’s biggest challenge may be to fend off takeover bids.”
In all, Geron invested 15 years and a whopping $150 million into embryonic stem cell research.
Only to abruptly dump it? What a difference a year makes. The value of Geron’s stock in the past year has fallen 70%, and since last week’s announcement it has only sunk lower. It is laying off 38% of its workers.
But I am not alone in sensing something more is afoot. One speculation, according to Science Magazine:
The development of induced pluripotent stem (iPS) cells, which are adult cells genetically reprogrammed to resemble embryonic ones, means that Geron’s exclusive licenses may be worth less.
Or worthless, hopefully – obsolete. iPS cells are skin cells thought to have the same ability as embryonic stem cells to grow a variety of ways 1) without the controversy; and 2) without the potential for rejection, since iPS cells come from a patient’s own body and not someone else’s, such as cells from embryos.
Another possibility, quoting ABC News:
“This company would not walk away from this trial in the absence of an unexpected complication or safety concern, if there was any evidence that it was working,” said Dr. Daniel Salomon, associate professor in the department of molecular and experimental medicine at the Scripps Research Institute in San Diego.
I spoke with Dr. David Prentice (pictured right) of Family Research Council today. Dr. Prentice is an expert in the field of stem cell research.
Dr. Prentice also speculates something went wrong with the spinal cord trials, which will eventually come to light if true.
“Note the phrase that always shows up,” said Dr. Prentice, “that there are no ‘serious‘ adverse events,” a red flag he thinks.
This is true. Quoting the Associated Press: “So far, the treatment… has been tolerated well without any serious side effects, the company said.”
Quoting Geron’s own press release: “To date, GRNOPC1 has been well tolerated with no serious adverse events.”
Geron and MSM have countered that this initial trial was only to test safety, not improvement.
“But Geron was obviously looking for something positive, beyond that the treatment doesn’t kill the patient,” said Dr. Prentice. “Thirty percent of patients show spontaneous improvement in the first year, and I’m betting Geron was going to take credit.” But nada.
In all, the spines of five patients were injected with embryonic stem cells. Geron has committed to following these patients for 15 years, well beyond the normal length of time trial patients are typically followed. “You only follow that long for something that might cause a tumor,” explained Dr. Prentice, “because it takes years for these tumors to show up.”
Indeed, the chief problem found with embryonic stem cells is they uncontrollably grow into tumors.
Dr. Prentice suspects Geron’s embryonic stem cell department has become a “hot potato” it will now find difficult to dump. The very fact it is halting embryonic stem cell research for economic reasons makes it economically unappealing to buyers.
Some say Geron’s decision may have dealt a death knell to embryonic stem cell research altogether, “wonder[ing] whether the field of embryonic stem cell research has been abandoned in the U.S. completely,” according to ABC.
That may be true of investors, but there’s always government funding, i.e., money belonging to you and I.
[Also read follow-up post, “Geron was awarded three cash grants through Obamacare for now defunct embryonic stem cell research program”]