Stephanie M. Lee
August 29, 2014
http://www.sfgate.com/health/article/Asterias-Biotherapeutics-to-launch-stem-cell-5717145.php
Almost three years after a Bay Area company shut down the world's first clinical trial of a therapy using embryonic stem cells, another local company is reviving the therapy.
The treatment drew international attention in 2010, when Geron in Menlo Park began testing it in patients with severe spinal cord injuries. But it scrapped the project a year later because of a lack of funds - a move seen as a major blow to the nascent field.
The therapy was then sold to Asterias Biotherapeutics, also in Menlo Park. On Wednesday, Asterias said it had gained regulatory permission to test whether the treatment, which is derived from human embryonic stem cells, helps heal patients with a different kind of spinal cord injury.
Observers saw the news as a promising advancement for research in stem cells, which have the unique ability to both reproduce themselves and become tissue- or organ-specific cells. That regenerative capability could be harnessed to treat intractable diseases and injuries, scientists believe. But no stem cell-based therapies have made it to market.
"It's a step in the right direction," said Enal Razvi, who studies the stem cell market as managing director of Select Biosciences, a life sciences consulting firm. "It actually shows that all the stakeholders want to make it work."
The trial was also described as a victory by the state's taxpayer-funded stem cell agency. Created by voters a decade ago, the California Institute for Regenerative Medicine is authorized to spend $3 billion on stem cell research, and its future rests on the results, including any potential therapies, that those scientists and companies develop. A $14.3 million grant will cover half the costs of Asterias' trial, the company said.
"It's a huge development for the field," said Kevin Whittlesey, science officer at the agency. "We're starting to realize the potential touted so highly when embryonic stem cell research was in its infancy."
Clearing 1st hurdle
After struggling for years to get permission to start a clinical trial, Geron abandoned it in November 2011, saying it couldn't afford to continue. In October 2013, it sold the program to Asterias, a then-new subsidiary of the Alameda company BioTime, in exchange for about 6.5 million shares of Asterias and undisclosed royalties. Geron is now struggling to develop experimental drugs for rare blood cancers.
With some tweaks, Asterias is picking up where Geron left off. Geron treated severe injuries in the thoracic region of the spinal cord, which runs along the back. Asterias is targeting injuries that originate in the neck, citing an outside study that suggests injuries in this area are easier to treat. It will also amp up the doses used to inject patients.
In a tiny trial with just five patients, Asterias said in May that the treatment appeared to be safe, the first hurdle all therapies must clear. In the upcoming trial with 13 patients, Asterias hopes to show the treatment is not only safe, but can also aid recovery from paralysis - a point Geron never reached.
"We are very excited with the potential to impact the lives of the many people that have spinal cord injuries, and believe this is a major step in being able to address what up to now has been an area that has no recourse, no medicine, no therapy that has proven effective for these patients," said Pedro Lichtinger, CEO of Asterias, which saw its stock climb 30 cents to $2.73 Wednesday. The trial will enroll patients next year.
No approved treatments
An estimated 1.3 million Americans have a spinal cord injury, which has no approved treatments. So scientists see hope in embryonic stem cells, which can turn into virtually any type of tissue in the body under certain conditions. But these cells have also been controversial, because their creation usually involves the destruction of human embryos. In 2001, then-President George W. Bush limited federal tax dollars for embryonic stem cell research, a policy that President Obama overturned by executive order in 2009, and some states have placed their own restrictions on such research.
Asterias is not the only stem cell company that has recently ventured into clinical trials. ViaCyte, a privately held company in San Diego, said this month that it won regulatory permission to start the first test of an embryonic stem cell-derived therapy in patients with Type 1 diabetes. ViaCyte has received nearly $40 million from the state's stem cell agency.
Lichtinger said that if the clinical trial goes perfectly, the therapy could reach consumers in less than a decade.
Razvi, the life sciences analyst, cautioned the public to not get too excited. "This is just the start of a trial, not the approval of a drug, which are two very, very different things in this space," he said. But "this helps things go to the next level."
An earlier version of this story incorrectly stated the value of Asterias Biotherapeutics stock.
Stephanie M. Lee is a San Francisco Chronicle staff writer. E-mail: slee@sfchronicle.com Twitter: @stephaniemlee
August 29, 2014
http://www.sfgate.com/health/article/Asterias-Biotherapeutics-to-launch-stem-cell-5717145.php
Almost three years after a Bay Area company shut down the world's first clinical trial of a therapy using embryonic stem cells, another local company is reviving the therapy.
The treatment drew international attention in 2010, when Geron in Menlo Park began testing it in patients with severe spinal cord injuries. But it scrapped the project a year later because of a lack of funds - a move seen as a major blow to the nascent field.
The therapy was then sold to Asterias Biotherapeutics, also in Menlo Park. On Wednesday, Asterias said it had gained regulatory permission to test whether the treatment, which is derived from human embryonic stem cells, helps heal patients with a different kind of spinal cord injury.
Observers saw the news as a promising advancement for research in stem cells, which have the unique ability to both reproduce themselves and become tissue- or organ-specific cells. That regenerative capability could be harnessed to treat intractable diseases and injuries, scientists believe. But no stem cell-based therapies have made it to market.
"It's a step in the right direction," said Enal Razvi, who studies the stem cell market as managing director of Select Biosciences, a life sciences consulting firm. "It actually shows that all the stakeholders want to make it work."
The trial was also described as a victory by the state's taxpayer-funded stem cell agency. Created by voters a decade ago, the California Institute for Regenerative Medicine is authorized to spend $3 billion on stem cell research, and its future rests on the results, including any potential therapies, that those scientists and companies develop. A $14.3 million grant will cover half the costs of Asterias' trial, the company said.
"It's a huge development for the field," said Kevin Whittlesey, science officer at the agency. "We're starting to realize the potential touted so highly when embryonic stem cell research was in its infancy."
Clearing 1st hurdle
After struggling for years to get permission to start a clinical trial, Geron abandoned it in November 2011, saying it couldn't afford to continue. In October 2013, it sold the program to Asterias, a then-new subsidiary of the Alameda company BioTime, in exchange for about 6.5 million shares of Asterias and undisclosed royalties. Geron is now struggling to develop experimental drugs for rare blood cancers.
With some tweaks, Asterias is picking up where Geron left off. Geron treated severe injuries in the thoracic region of the spinal cord, which runs along the back. Asterias is targeting injuries that originate in the neck, citing an outside study that suggests injuries in this area are easier to treat. It will also amp up the doses used to inject patients.
In a tiny trial with just five patients, Asterias said in May that the treatment appeared to be safe, the first hurdle all therapies must clear. In the upcoming trial with 13 patients, Asterias hopes to show the treatment is not only safe, but can also aid recovery from paralysis - a point Geron never reached.
"We are very excited with the potential to impact the lives of the many people that have spinal cord injuries, and believe this is a major step in being able to address what up to now has been an area that has no recourse, no medicine, no therapy that has proven effective for these patients," said Pedro Lichtinger, CEO of Asterias, which saw its stock climb 30 cents to $2.73 Wednesday. The trial will enroll patients next year.
No approved treatments
An estimated 1.3 million Americans have a spinal cord injury, which has no approved treatments. So scientists see hope in embryonic stem cells, which can turn into virtually any type of tissue in the body under certain conditions. But these cells have also been controversial, because their creation usually involves the destruction of human embryos. In 2001, then-President George W. Bush limited federal tax dollars for embryonic stem cell research, a policy that President Obama overturned by executive order in 2009, and some states have placed their own restrictions on such research.
Asterias is not the only stem cell company that has recently ventured into clinical trials. ViaCyte, a privately held company in San Diego, said this month that it won regulatory permission to start the first test of an embryonic stem cell-derived therapy in patients with Type 1 diabetes. ViaCyte has received nearly $40 million from the state's stem cell agency.
Lichtinger said that if the clinical trial goes perfectly, the therapy could reach consumers in less than a decade.
Razvi, the life sciences analyst, cautioned the public to not get too excited. "This is just the start of a trial, not the approval of a drug, which are two very, very different things in this space," he said. But "this helps things go to the next level."
An earlier version of this story incorrectly stated the value of Asterias Biotherapeutics stock.
Stephanie M. Lee is a San Francisco Chronicle staff writer. E-mail: slee@sfchronicle.com Twitter: @stephaniemlee