2nd UPDATE: NIH Panel: Unclear If Gene Therapy Caused Death

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2nd UPDATE: NIH Panel: Unclear If Gene Therapy Caused Death

September 17, 2007:* 06:38 PM EST

CNNMoney.com - USA

http://money.cnn.com/news/newsfeeds/articles/djf500/200709171838DOWJO

NESDJONLINE000685_FORTUNE5.htm

By Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow )- A federal government panel said Monday it's

not yet clear what role an experimental gene-therapy treatment

played in a women's death in July.

The National Institutes of Health advisory panel, which helps

oversee gene- transfer research, looked at the case of a 36-year-old

Illinois woman who died a few weeks after receiving a proposed

treatment for rheumatoid arthritis made by Targeted Genetics Corp.

(TGEN) of Seattle.

The Food and Drug Administration halted the study and won't consider

allowing it to move forward until an investigation into the death of

the patient, Jolee Mohr, is complete.

Doctors involved with Mohr's care presented the details of her case

to the panel on Monday, which showed she had a fungal infection

known as histoplasmosis and was bleeding internally when she died on

July 24. But, so far doctors haven't been able to determine what

caused the bleeding or whether the fungal infection was severe

enough to have caused her death. Mohr also developed various blood

disorders while in the hospital.

Mohr was injected with the therapy, which uses a virus to transport

a gene that churns out copies of a receptor to block excess amounts

of the inflammatory molecule known as tumor necrosis factor that

plays a role in rheumatoid arthritis, on July 2nd. Doctors said she

reported feeling ill and had a low- grade fever a few days prior to

receiving the injection. Mohr was also on several other prescription

medications including Abbott Laboratories' (ABT) Humira, which is

used to treat rheumatoid arthritis, doctors said.

" The best answer we have to offer today is we don't know " if the

treatment contributed to Mohr's death, said Dr. Federoff, the

panel chairman and executive dean at town Medical School. He

said he hoped ongoing testing, including looking at blood samples to

see if the product was in Mohr's blood, would be able to provide an

answer, although he said he thinks there will always be uncertainty

even after those test results are complete.

Initial tests have shown there was only trace amounts of the

product, or vector, in tissues outside the joint where it was

injected.

" While additional tests are needed to draw final conclusions, we

believe the results to date are consistent with preclinical and

clinical findings that indicate the level of vector that is present

outside the locally treated area is insufficient to have further

exacerbated an infection, " said H. , Target Genetics

chief executive.

Robb Mohr, Jolee Mohr's husband, said he thinks his wife would still

be alive if she hadn't received the gene therapy. " Until you figure

out what's going on don't let this happen to anybody else, " Mohr

urged the panel.

Federoff said Jolee Mohr's death and additional test results will be

discussed at a December panel meeting.

Targeted Genetics' shares closed down 5.1% to $1.86. Abbott shares

closed down 11 cents to $51.99.

-By Corbett Dooren, Dow Newswires; 202-862-9294;

.Corbett@...