Undiff. Stem Cells

 


First Government-Approved Embryonic Stem Cell Trial Stopped in Its Tracks By Economy
 

 

popsci.com  Nov. 15, 2011

http://www.popsci.com/science/article/2011-11/first-government-approved-embryonic-stem-cell-trial-stops-its-tracks


By Rebecca Boyle Posted 11.15.2011 at 1:58 pm

The first company to start human clinical trials using embryonic stem cells is quitting the project and laying off more than a third of its staff. Geron Corp. said it is discontinuing its FDA-approved stem cell test and turning its focus to cancer treatment instead.

The news is a blow to advocates of embryonic stem cells as a potential treatment for a wide range of ailments. The trial, which started last fall, was progressing nicely, according to Geron’s own statements as of October — four patients had received treatment so far with no negative side effects. But Geron could not continue the research “In the current environment of capital scarcity and uncertain economic conditions,” John A. Scarlett, Geron’s chief executive officer, said in a statement Monday afternoon.

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The clinical trial aimed to demonstrate the safety of embryonic stem cells as a potential treatment for spinal cord injuries. Geron will continue to follow patients who have already enrolled in the trial and have received treatment, but will not accept any new patients. The company will also continue to update the FDA on the current participants’ progress.

The patients in question received injections of 2 million stem cells within 7 to 14 days of a debilitating spinal cord injury. They also received immune-suppressing drugs and multiple MRI scans to monitor their progress. The therapeutic dose, called GRNOPC1, contained oligodendrocyte progenitor cells that were derived from human embryonic stem cells. The treatment is controversial because obtaining those cells require the destruction of a human embryo.

Stem cell research advocates voiced frustration Monday and Tuesday, perhaps none as powerfully as Daniel Heumann, who sits on the board of the Christopher and Dana Reeve Foundation. The Washington Post quoted him as saying he was “disgusted” by the news: “It makes me sick. To get people's hopes up and then do this for financial reasons is despicable. They're treating us like lab rats,” he said.

Along with the spinal cord trial, Geron was also testing embryonic stem cell treatments for cardiac cells; a type of pancreas cells for diabetes; cartilage cells; and immune system cells called dendritic cells, the AP reported. These projects will all cease and the company will turn instead to its cancer therapy programs. The company is looking for buyers to take on some of its stem cell-related assets, according to a news release. Meanwhile, 66 full-time positions, representing 38 percent of the company’s workforce, are being eliminated.

Geron is not the only company in a clinical trial phase — a Scottish patient at Glasgow's Southern General Hospital received a stem cell transplant following a stroke last year, and this summer, a different California company started a clinical trial using embryonic stem cells to treat blindness.


Embryonic Stem Cell Research Halted, Staff Laid Off

Published November 15, 2011

| Associated Press

The company doing the first government-approved test of embryonic stem cell therapy is discontinuing further stem cell work, a move with stark implications for a field offering hope of future medicines for conditions with inadequate or no current treatments.

Geron Corp., a pioneer in stem cell research that has been testing a spinal cord injury treatment, said late Monday that it's halting development of its stem cell programs to conserve funds. It is seeking partners to take on the programs' assets and is laying off much of its staff.

 

The news sent Geron shares down sharply in after-hours trading. They fell 38 cents, or 17.3 percent, to $1.82.

The company is eliminating 66 full-time jobs, or 38 percent of its staff, a process that will bring about $8 million in costs — about $5 million in the current quarter and about $3 million in the first half of 2012. Geron said it expects to end this year with more than $150 million in cash and investments.

In a statement, the company said the decision to narrow its focus "was made after a strategic review of the costs, ... timelines and clinical, manufacturing and regulatory complexities associated with the company's research and clinical-stage assets."

The shift comes barely six weeks after the company's board appointed biotech industry veteran Dr. John A. Scarlett as Geron's new chief executive.

Geron said it is looking for partners who have the technical and financial resources to advance its stem cell programs.

Analyst Steve Brozak of WBB Securities said Geron has been trying to find partners "and people have said,'Show us later-stage results.'"

Since the recession began in 2008, venture capital funding for the biotech industry has greatly declined as many investors seek projects with quicker potential payoffs.

Embryonic stem cells can develop into any type of cell in the body. The hope is that one day they might be used to replace or repair damaged tissue from ailments such as heart disease, Parkinson's and stroke.

But using stem cells from embryos has long been controversial and is opposed by some groups for religious and moral reasons.

Brozak called Geron's move a sad delay in the development of embryonic stem cell therapies in the U.S.

"It could be outsourced to a place like China very easily," he added. "In that case, this would be the de facto abdication of U.S. leadership in biotechnology."

Scarlett said his company will keep a core group of employees from its stem cell operations through the end of 2012's second quarter.

"Stem cells continue to hold great medical promise," he said in a statement, adding that Geron is recognized as having "among the most innovative, comprehensive and advanced cell therapy programs in the world," which should help it in discussions to find partners to whom it can transfer the programs.

Geron in October 2010 began testing an embryonic stem cell therapy called GRNOPC1 in patients with recent spinal cord injuries. It will stop enrolling new patients but will continue to follow those currently participating.

The company will continue updating the Food and Drug Administration and doctors and scientists on the study's progress. So far, the treatment with oligodendrocyte progenitor cells — the OPC in the therapy's name — has been tolerated well without any serious side effects, the company said.

Geron also is testing embryonic stem cell treatments using cardiac cells for heart disease, a type of pancreas cells for diabetes, cartilage cells for cartilage repair and immune system cells called dendritic cells for immunotherapy treatments.

Geron, based in Menlo Park, Calif., now will focus soley on cancer research, particularly on drugs that are in mid-stage human testing.

Those include imetelstat for advanced breast cancer, advanced non-small cell lung cancer, a blood-clotting disorder called essential thrombocythemia and multiple myeloma, a bone marrow cancer, and of a therapy called GRN1005, for cancer that has spread to the brain from the breast or lungs.


 

ONDON | Tue Nov 15, 2011 10:48am EST

(Reuters) - A decision by one of the biggest names in stem cell research to throw in the towel will not stop other pioneering work that could yet produce cures for blindness and help mend broken hearts.

Scientists were shocked by U.S. biotech company Geron Corp's decision on Monday to quit embryonic stem cell research -- a move it blamed on a lack of money and the complexities of getting regulatory approval.

Yet, at the same time, teams working with adult stem cells -- a less ambitious area -- are making good progress.

"This is not the end of an era," said Dusko Ilic, senior lecturer in stem cell science at King's College London.

Shortly before Geron told the world it was ending further development of its embryonic stem cell projects, Australia's Mesoblast Ltd reported its adult stem treatment slashed the rate of further heart problems in heart failure patients.

"It's a tale of two ends of the market. I believe the adult stem cell space was always more attractive anyway," said Navid Malik, a biotechnology analyst at Merchant Securities.

Stem cells potentially offer a new way of treating diseases for which there are currently no treatments -- including heart disease, Parkinson's and stroke -- by regenerating tissue.

Embryonic stem cells are harvested from embryos and have the potential to become almost any type of tissue. Adult stem cells are less controversial, but are also less flexible.

Like Malik, scientists agreed Geron had started in a difficult place in testing economic times.

In its most advanced project, Geron was testing an embryonic stem cell treatment aimed at helping patients with spinal cord injuries like the late Superman actor Christopher Reeves, who was paralyzed in a horse-riding accident.

"Making superman walk would have been great for business but was an ambitious target for a serious problem and maybe not the best start scientifically or clinically for stem cell therapies," said Alison Murdoch, head of the fertility center at Britain's Newcastle University.

The first patient was treated in October 2010 with Geron's product called GRNOPC1, containing cells that had been manipulated to become precursors to nerve cells.

INVESTMENT RETURN

Other research teams are focusing on eye disorders such as age-related macular degeneration (AMD) or on ways to repair damaged heart tissue -- areas where experts say progress and, crucially, return on investment is likely to be quicker.

Pfizer Inc, for example, is working with University College of London's Institute of Ophthalmology on an embryonic stem cell treatment for AMD and is now awaiting a green light to commence clinical trials in Britain.

Advanced Cell Technology (ACT) is starting early-stage human trials in the United States and Britain using embryonic stem cells in patients with a progressive form of blindness called Stargardt's macular dystrophy.

"Getting the business case right is as important as getting the science right for each stem cell therapy that we develop," said Anthony Hollander, a professor of Rheumatology and Tissue Engineering at the University of Bristol.

The ethical controversy surrounding embryonic stem cells can also have hard commercial implications, as highlighted by a ruling from Europe's top court last month that has left the business case for embryonic stem cells in limbo.

The European Court of Justice decided to ban the patenting of any stem-cell process that involves destroying a human embryo, in a move described by scientists as a major blow to the emerging field of research.

That court decision will have given pause for companies looking into embryonic stem cells but it will not affect adult stem cells derived from bone marrow, fat or skin.

"The adult stem cell space is moving forward very fast," said Malik. "We're going to see filings for regulatory approval in the next three to five years for a series of products."

Robert Lanza, chief scientific officer of ACT, is not giving up hope on the embryonic front but said Geron's exit put more pressure on his firm to succeed.

"Of course, it's the second mouse that often gets the cheese," he said.

(Additional reporting by Julie Steenhuysen in Chicago; Editing by David Cowell)