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FDA lifts partial hold on study testing myelofibrosis drug

FDA lifts partial hold on study testing myelofibrosis drug

By Natalie Grover

(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.

Enrollment in the early-stage trial, sponsored by the Mayo Clinic, was halted in March over concerns about liver toxicity pending follow-up 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 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.

Imetelstat was touted as the company's savior after curing 22% of myelofibrosis patients in a trial last year.

The FDA is likely to eventually allow new company-sponsored trials for myelofibrosis, Needham analyst Chad Messer said in a note, while maintaining his "hold" rating on the stock based on the continued high level of uncertainty.

If approved, Geron's drug would compete with Incyte Corp's myelofibrosis drug, Jakafi, which generated sales of $235.4 million last year.

Some analysts have indicated that imetelstat's ability to evoke a partial or complete remission suggests it would be superior to Jakafi.

Imetelstat is designed to inhibit telomerase, an enzyme that enables the rapid multiplication of tumor cells.

The company had earlier discontinued testing the drug for treatment of breast and lung cancer after trial failures.

 
 
 
 
                 
 
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