FDA Delays Clinical Trails of Embryonic Stem Cells

by Jennifer Lahl, CBC President on May 16, 2008

Hah! The FDA, in its great and infinite wisdom said “now wait a minute” to Geron Corporation. Here’s the scoop in its entirety.

The Geron Corporation announced Wednesday that its plans to begin the first clinical trial using embryonic stem cells had been delayed by federal regulators.

The company, based in Menlo Park, Calif., had planned to begin a human trial soon to test its stem cell compound in patients with spinal cord injuries.

The company received oral notice about the delay from the Food and Drug Administration on Wednesday and is awaiting a letter from the agency explaining its decision, said Geron’s chief executive, Thomas B. Okarma.

Ren Benjamin, an analyst with Rodman & Renshaw, said the F.D.A. action was not surprising and was likely to delay rather than stop the trial.

While companies typically do not announce when they submit an application to begin a trial for an investigational new drug, the F.D.A.’s action means Geron must have submitted its application in the last 30 days, Mr. Benjamin said.

The F.D.A. convened a meeting April 10 of expert advisers who stressed the need for stringent safety measures in embryonic stem cell trials.

Steven Bauer, chief of the F.D.A.’s cell and tissue therapy branch, said at the meeting that the agency might require “particularly strong” evidence early in studies that stem cell treatments are effective. The agency may also require longer trials of stem cell therapies than it does for conventional drugs, Mercedes Serabian, a supervisory toxicologist for the agency, said after the meeting.

The company will announce its plans once it receives the F.D.A. letter, Mr. Okarma said. “We are disappointed with this action given the interactions we had with the F.D.A. over four years leading to the filing” of the company’s 21,000-page application for the trial, he said.

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