A small sigh of relief for Geron as FDA lifts partial clinical hold on trials of its only drug

(Reuters) - Geron Corp said the U.S. Food and Drug Administration had lifted a partial clinical hold on a study testing its sole drug as a treatment for myelofibrosis, a rare form of blood cancer, sending the company's shares soaring in early trading.

Enrollment in the early-stage trial, sponsored by the Mayo Clinic, was halted in March over concerns about liver toxicity pending followup data from Mayo's investigator on the possible reversibility of the liver damage.

Enrollment for the study ceased in January, and about 20 of the 79 patients dropped out.

Geron, whose shares rose as much as 29 percent in early trading on Thursday, did not then disclose the reason behind the dropouts, but said the remaining enrolled patients would continue to receive the drug, imetelstat.

However, in March the FDA also imposed a halt on separate company-sponsored trials evaluating the use of the drug in thrombocythemia and multiple myeloma, citing similar concerns.

Geron said on Thursday the company-sponsored trials remain suspended.

Stifel Nicolaus & Co analyst Brian Klein said that while the FDA's lift on the partial hold was positive, it was unlikely that the Mayo Clinic would enroll new patients.

As the partial hold had not prevented Mayo from dosing patients already enrolled, Thursday's announcement will make no difference to the final results of the study, he said.

Klein said he did not expect the FDA to lift its hold on company-sponsored trials in the next few months.

Geron, once one of the leading firms in the race to develop the first commercial stem-cell therapy, divested its stem-cell assets last year to focus on cancer treatments.

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A small sigh of relief for Geron as FDA lifts partial clinical hold on trials of its only drug