3 replies to this topic

[Apparelyzed]

Geron says FDA puts cell therapy drug on clinical hold

Geron Corp (GERN.O: Quote, Profile, Research) said U.S. health regulators placed a clinical hold on its investigational new drug submission for GRNOPC1, a cell therapy for spinal cord injury, sending its shares down 22 percent to their lowest in more than four years.

"We have not yet received a letter from the FDA explaining the decision to place the submission on hold, so we are unable to comment specifically," Chief Executive Thomas Okarma said in a statement.

The biopharmaceutical company said it had received a verbal notice from the U.S. Food and Drug Administration about the clinical hold.

A clinical hold is an order that the FDA issues to delay a proposed trial or to suspend an ongoing investigation.

Shares of the company, which is working to develop therapeutics based on human embryonic stem cells, fell $1.08 to $3.82 in late trade on Nasdaq. (Reporting by Aradhana Aravindan in Bangalore; Editing by Himani Sarkar)

Source: http://www.reuters.c...G12626120080514

[topperf]

WHY? fda isn't telling, why is that?

[Apparelyzed]

This may have something to do with the delay:

" The biopharmaceuticals firm has been seeking approval to begin testing of embryonic therapies in humans, in Geron's case for treating spinal-cord injuries. It has so far been tested in rats and the company wants to test the therapy in certain patients who have had spinal-cord injuries starting seven to 14 days after the injury.

Steven Bauer, chief of FDA's cell and tissue therapy branch, said last month the agency is considering requiring future therapies derived from human embryonic stem cells to meet tougher effectiveness standards earlier in the clinical development progress than currently required for drugs and medical devices.

Embryonic stem cells have the ability to grow quickly and act like almost any other cell in the body. However, animal tests have shown embryonic stem cells can cause benign tumors called teratomas, and there are concerns the cells have the potential to cause malignant tumors along with other unintended consequences."

Source: http://money.cnn.com...NLINE000895.htm

[topperf]

yes, unintended consequences, doesn't sound nice.

still, fda has only given a verbal decline, geron will have it in writing by wed. next week. at least, that is the info i can find...

maybe i'm a bit naive, but i hope geron applyed because they thought that it was safe to start human trials..?

Edited by topperf, 17 May 2008 - 07:45 PM.