Human tests of embryonic stem cell therapies to start?

Human tests of embryonic stem cell therapies to start? Wednesday, 31 October 2007 Geron Corp. and Advanced Cell Technology Inc. are getting ready to start clinical testing of embryonic stem cells for different conditions next year, CNN reports today. Both companies are preparing to submit applications to the FDA to begin human testing of experimental treatments that are based on ESCs. If the companies get the go-ahead, they could begin tests as soon as next year. In the past, the FDA has approved human tests of products based on stem cells taken from adult tissue. But Geron and ACT would be the first to begin human testing of treatments based on the more controversial research using stem cells derived from embryos. Human tests are the most advanced form of testing and one of the final hurdles before the FDA approves a drug. Geron has already met with the FDA and will submit its plans for human testing to the agency by the end of this year, according to Sion Rogers, a spokesman for the company. "We expect to be in the clinic [for human testing] next year," said Rogers. ACT plans to submit its application for human testing to the FDA by the middle of next year, said Chief Executive Robert Lanza, who spoke at the 7th International Stem Cell Conference on Tuesday. His company is developing potential treatments for vision loss diseases, including macular degeneration and Stargardt's, based on studies involving monkeys. Geron and ACT will not compete with each other because their potential products are unrelated. "We think that it doesn't matter who gets to the clinic first, because the entire stem cell space will benefit when someone gets there," said Ren Benjamin, analyst for Rodman & Renshaw. "It will create a lot of excitement in investors, because it's a big milestone for the embryonic stem cell space." Novocell, another privately-held biotech based in San Diego, uses embryonic stem cell research in developing treatments for diabetes. Chief Executive Alan Lewis said that he is a couple of years behind Geron and ACT, and he is yet to finish studies using mice. "The study needs to be completed before we got out and bang a drum and talk about curing diabetes," said Lewis. ......... ZenMaster

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