Responding to the news that Geron received FDA permission to begin the first U.S. clinical trial of an embryonic stem cell (ESC) product, GRNOPC1, in patients with acute spinal cord injury, Linda Powers, co-founder and managing director of Toucan Capital, a $140 million venture capital fund, said the development “opens the door to the most important phase of a new era of regenerative medicine—namely, getting the fruits of research into the clinic.”

The fund’s portfolio, emphasizes Powers, holds the largest number of stem cell, regenerative medicine, and living cell companies in the world [16 companies]. “This is a step in making real treatments available for real people.

“Geron was most likely given the go-ahead to do the first trial because in the embryonic stem cell world, the company is the largest, most established, and farthest ahead on ESC product development,” she maintained. “Geron has been working in this area for years.”

She was quick to note that earlier this week, a British company, ReNeuron, won regulatory approval from U.K. authorities to initiate a clinical trial with gene-modified neural stem cells for the treatment of stroke. “These are not embryonic stem cells but another category of stem cells that has been held up for years by regulators despite a record of solid science.”

ReNeuron had sought permission from the FDA for over two years to do the trials in the U.S. but finally gave up and went home to carry out the study in Britain. “The Geron approval is significant for the entire field of stem cell and regenerative medicine and should certainly help our companies move forward,” continued Powers.

Clinical Development
Two of Toucan Capital’s companies are already in various stages of clinical development. Vesta Therapeutics has an approved IND for a Phase I trial using liver stem cells for liver repair. “A lot of people don’t realize what a huge issue liver problems are in the U. S. but it is a ticking time bomb,” said Powers. “There are several million cases of hepatitis C in the U.S. alone.”

The other company, Theradigm, is on the threshold of moving into a Phase I trial with neural stem cells for the treatment of stroke, according to Powers. “Stroke is one of the most expensive medical conditions in the U.S.,” she explains. “One-third of stroke patients experience significant disability. Clinical trials could take place within a year.”

While endorsing the potential of ESCs too, Powers gets a bit frustrated when she reads newspapers about this research. “Most articles in the press make you think that only embryonic stem cells are capable of doing anything therapeutically,” she said “No doubt, this is a jazzy field and it gets lots of grant money, but adult stem cells are farther along and can do a lot of medical repair jobs quite well.”

Outside the U.S., where there have been no artificial restrictions as in America, the majority of studies taking place in this field are with adult stem cells, she claimed.

Powers also believes that not enough attention is being paid to the biomanufacture of stem cells and other living cells. Another Toucan Capital firm, Cognate Bioservices, utilizes GMP facilities to perform contract manufacturing of cell-based products.

“Living cell biomanufacturing is a key industry for the future,” noted Powers. “A whole spectrum of job categories is involved here, including technician jobs that do not require college degrees. Trained technicians can make $40,000–50,000 a year, and this can help replace all those $20-an-hour jobs that have disappeared from Detroit and other manufacturing dead zones.”

Powers stressed that the U.S. can take the lead in the biomanufacturing of stem cells and other living cells if the will is there. She adds that the facilities for living cell manufacture are vastly different from those of other biologics.

“Small molecule manufacturing requires medicinal chemistry. Biologics necessitates the use of fermenters and bioreactors,” she pointed out. “What you need to carry out research on living cells are biosafety cabinets and incubators—an entirely different range of facilities and equipment than for biologics or small molecule drugs.”

“We are really just at the dawn of an entirely new biomanufacturing industry, and the U.S. can either capture this opportunity or lose it to other countries who are vigorously pursuing it.”


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