Geron

Geron, Exeter launch animal cloning venture

John Carroll — Wed, 13 Aug 2008 11:53:48 -0400

Geron and Exeter Life Sciences have created a joint venture--Start Licensing Inc.--to manage intellectual property rights revolving around animal reproductive technology, a field that includes animal cloning. "It makes sound business sense to join a patent estate for nuclear transfer that has been tested and is recognized as dominant with a leading operating company in the field," said David Greenwood, Geron's CEO.

The new company "combines the full breadth of intellectual property rights to nuclear transfer cloning technology, including that developed at the Roslin Institute for cloning Dolly the sheep, with in-house state-of-the-art breeding services and expertise in advanced reproductive technologies, particularly in cloning, to provide a one-stop licensing and operating company," the companies said.

- here's the release for more
- read the report in the San Jose Business Journal

FDA's delay of Geron ESC trial raises concerns

Thu, 15 May 2008 06:59:57 -0400

Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental therapy for spinal cord injuries. Geron, which has been racing to become the first biotech with a hESC therapy in clinical trials, says it was given verbal notice that regulators are putting a hold on the planned trial. The company's shares plunged 20 percent on the news.

No details were offered on the reasons for the delay, though Geron's Dr. Thomas Okarma noted that "we are disappointed with this action given the interactions we had with the FDA." Analysts also note that FDA delays can be routine and of short duration.

Advanced Cell Technology has also been in the running to launch an ESC trial, which they hope to get approval for this year.

- check out Geron's release
- read the report from the San Jose Mercury News

What's in store for stem cell treatments?

Fri, 11 Apr 2008 06:59:55 -0400

At yesterday's hearing on stem cells, the FDA set a high bar for the treatments, saying that any therapies would have to have very compelling data in order to move into human trials. The FDA's wariness is due to uncertainty about stem cells effects on the body. While the treatments show promise, researchers do not yet have all the answers regarding the long-term effects of such treatments. Tumors, in particular, are a concern. Geron, Novocell, Neuralstem and Advanced Cell Technology are nearing human trials--uncharted territory for stem cell therapies.

The FDA took a key step as it began drafting a blueprint for how the stem cell therapy trials would be conducted. "We've talked about how long we need to monitor people for, and the answer is forever," said Gordon Weir, a panelist on the advisory committee. "We're putting in these cells, and we don't know what they're going to cause in terms of trouble." Drug developers are looking to the FDA to elucidate the regulatory hurdles they'll face as stem cell therapies move through clinical trials. Without clear guidelines, drugmakers will face an unclear development process complicated by uncertainty and controversy.

- check out the CNNMoney article
- read this Wall Street Journal report for more

Related Articles:
Stem cell developers shift focus to FDA hearings. FDA report
Stem cell outfits a winner in upcoming election. Election report
NIH chief breaks with Bush on stem cell research. Report
Stem cell advance runs into conservative roadblock. Stem cell report
Stem cell market shows signs of fast growth. Stem cell report

ALSO NOTED: YM cleared for Phase II; pine needle approach studied for ulcers; Applera in buyback plan; and much more...

Fri, 31 Aug 2007 06:59:50 -0400

> YM BioSciences has received FDA approval initiate a Phase II trial investigating nimotuzumab in pediatric patients. Release

> A prominent Russian scientist has been testing an experimental therapy made from green pine needles for helicobacter pylori bacterium (H.pylori), the root cause of stomach ulcers. FierceBioResearcher

> Applera, which owns the biotech company Applied Biosystems, has accelerated the repurchase of $600 million worth of its Applied Biosystems' shares. Report

> Pharmexa says it has prevailed against Geron in a patent dispute. Release

And Finally... Tiny fat bubbles can be used to deliver powerful chemotherapy drugs to tumor sites. Report