August 19, 2009 / 12:39 PM / 10 years ago

UPDATE 3-Gentium's liver drug fails late-stage trial; shrs fall

* Defibrotide fails to meet trial goals

* Sees defibrotide best positioned in a prevention setting

* Plans to present full trial results Dec 5-8

* Shares fall as much as 22 pct (Adds company comment, updates share movement)

BANGALORE, Aug 19 (Reuters) - Italian biopharmaceutical firm Gentium S.p.A. GENT.O said its experimental drug to treat the blockage of small veins in the liver missed the main goal of a late-stage study, sending its shares down as much as 22 percent.

Gentium shares recouped most of the losses to trade down 2 percent at $3.33 Wednesday afternoon on Nasdaq.

“We missed statistical significance but not by much,” Chief Financial Officer Gary Gemignani said by phone.

“We thought it was going to be much worse than it turned out and in fact this is very encouraging.”

Given the outcome of the data safety monitoring board’s interim review announced in November, the company expected that reaching the required statistical threshold for a single trial would be difficult, Gemignani said in a statement.

The company was testing the drug, defibrotide, for severe veno-occlusive disease (VOD), a potentially life-threatening condition that typically occurs as a complication of stem-cell transplantation.

Gemignani believes that the drug, which is also being developed as a preventive treatment for VOD in pediatric patients in Europe, will ultimately be best positioned in a prevention setting.

“When you look at many of the studies that have been conducted so far, there is a clear signal that the earlier the patient gets the drug, the better the likelihood of an outcome,” he said.

TRIAL RESULTS

The main goal of the trial was to measure the complete response at 100 days following a stem-cell transplant (SCT), compared with patients receiving the best therapy and supportive care available at the time.

While the standard measure for significance, called p-value for the primary endpoint, should be 0.01 or less in a clinical trial, defibrotide yielded a p-value of 0.015.

Defibrotide also failed to meet its secondary endpoint of survival rate at 100 days and six months post SCT.

Gentium plans to present full results from the trial from Dec. 5 to 8 at the American Society of Hematology Conference in New Orleans.

Gemignani also said the company plans to report final results from the pediatric prevention study in the upcoming weeks.

Shares of the company were down 6 percent at $3.20 Wednesday afternoon on Nasdaq. They had touched a low of $2.65 earlier in the session.

For the alerts double-click [ID:nWNBB7233] . (Reporting by Anand Basu in Bangalore; Editing by Deepak Kannan and Vinu Pilakkott)

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