Human stem cell tests could be near

Geron CEO plans embryonic stem cell tests in humans this spring if the biotech meets the FDA's 'high bar.'

Subscribe to Companies
google my aol my msn my yahoo! netvibes
Paste this link into your favorite RSS desktop reader
See all CNNMoney.com RSS FEEDS (close)
By Aaron Smith, CNNMoney.com staff writer

The dangers of legal drugs
The death of Heath Ledger has drawn attention to the dangers of legal prescription drugs. CNN's Alina Cho has more.

NEW YORK (CNNMoney.com) -- The first experiments using human embryonic stem cells in human subjects could begin within a few months, the chief executive of biotech Geron said Monday.

At the annual BIO CEO conference in New York, Dr. Thomas Okarma said Geron plans to start embryonic stem-cell studies in humans with spinal cord injuries toward the end of the second quarter. Okarma said the tests would involve up to 40 human patients, while all prior tests involved rats.

This assumes that the Food and Drug Administration gives Geron a green light to proceed with the human test. Okarma said the FDA will set a "high bar" in regulating this new type of science.

Ren Benjamin, analyst for Rodman & Renshaw, believes the regulatory process could be time-consuming, because it's unprecedented.

"This is the first time that a human embryonic stem cell application is being submitted to the FDA, so there's a good chance that some questions will arise," he said.

Geron (GERN), based in Menlo Park, Calif., is also in early-stage studies with stem cell-based drugs for diabetes and heart failure. All of these experimental treatments are years away from potentially entering the market.

Advanced Cell Technology Inc. and Novocell Inc. also use human embryonic stem cells, but Geron is the only one of the these companies that's traded on the Nasdaq. Advanced Cell plans to begin testing in humans this year, but Novocell is further behind.

Neuralstem (CUR) uses stem cells from aborted fetuses to research potential treatments for spinal cord injuries. Like Geron and Advanced Cell Technology, Neuralstem plans to begin testing in humans this year, assuming that the FDA gives it the go-ahead.

Cytori Therapeutics (CYTX) and Osiris Therapeutics (OSIR) use stem cells taken from adult human tissue, which insulates from the controversy surrounding the use of human embryonic stem cells, which are obtained through in vitro fertilization.

Human-based embryonic stem cells are prized by researchers for their ability to regenerate quickly and morph into different types of cells. Supporters believe their use could someday help people with spinal injuries walk again or cure patients with degenerative diseases like Alzheimer's and Parkinson's.

But the pro-life contingent, including President Bush, opposes using human-derived stem cells, on the grounds that it creates embryos only to destroy them. Supporters of the science dispute that notion, saying that the blastocysts used as stem cell sources would be thrown out as medical waste if they weren't used in research.

In 2001, President Bush limited federal funding for human-derived stem cells to only those lines that existed at the time. In 2007, he vetoed a Congressional bill to lift those restrictions.

But in November, scientists unveiled a new type of experimental technology on Nov. 21 that sent Geron's stock into a volatile tailspin. Research teams from the University of Wisconsin in Madison and the University of Kyoto in Japan separately announced that they'd "reprogrammed" adult cells to act like embryonic stem cells.

Geron's stock has fallen more than 40 percent since then, though Okarma shrugged off the potential threat of reprogramming because it's still in the infantile stages.

"The natural human embryonic stem cell is the gold standard and we have yet to see anything else come close," Okarma said at the BIO CEO conference Monday.

But Benjamin of Rodman & Renshaw doesn't believe reprogramming poses an immediate threat to Geron.

"I think [reprogramming] is very intriguing and has a lot of potential, but it's at a nascent stage that I consider more noise than anything else," said Benjamin.

Mark Gross, a physics professor at California State University who was attending the BIO CEO conference as a potential investor, agreed that reprogramming technology is in too early of a stage to threaten Geron.

"[Reprogramming] is promising, but these things take time and we don't know which path will lead to fruition and which will lead to a dead end," he said. To top of page

Photo Galleries
8 CEOs who took a pay cut in 2013 Median CEO pay inched up 9% in 2013 to $13.9 million. But not everyone got a bump last year. Here are eight CEOs who missed out. More
7 businesses Amazon wants to shake up From industrial supplies to educational software, Amazon is about more than just retail and books. More
Don't miss these Tax Day deals From massages and paper shredding to cookies and queso, celebrate the end of tax season with these Tax Day freebies and discounts. More
Sponsors
Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer LIBOR Warning: Neither BBA Enterprises Limited, nor the BBA LIBOR Contributor Banks, nor Reuters, can be held liable for any irregularity or inaccuracy of BBA LIBOR. Disclaimer. Morningstar: © 2014 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2014 is proprietary to Dow Jones & Company, Inc. Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2014. All rights reserved. Most stock quote data provided by BATS.
Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer LIBOR Warning: Neither BBA Enterprises Limited, nor the BBA LIBOR Contributor Banks, nor Reuters, can be held liable for any irregularity or inaccuracy of BBA LIBOR. Disclaimer. Morningstar: © 2014 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2014 is proprietary to Dow Jones & Company, Inc. Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2014. All rights reserved. Most stock quote data provided by BATS.