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Thursday February 1, 7:18 pm Eastern Time
Nabi sets more StaphVAX trials, to appeal FDA ruling
NEW YORK, Feb 1 (Reuters) - Drug maker Nabi Inc.
(NasdaqNM:NABI - news) said on Thursday it plans to conduct additional clinical
trials on its StaphVAX vaccine for blood infections, but would appeal a U.S.
Food and Drug Administration decision mandating the additional tests on the
vaccine.
The company has stated that StaphVAX reduced the presence
of harmful bacteria 10 months after being taken by patients, but the results
were not statistically significant after 12 months.
“It appears that for patients on one dose, up to 10
months, it provides protection and prevents infection,” said chairman,
president and CEO David Gury in a phone interview on Thursday.
The firm said it would move forward with creating a new
Phase III trial, assuming the FDA does not reverse its request for the
additional trial.
Nabi said it also expects to complete by early 2002 an
additional study, one that “boosts” patients with more doses during the months
of the trial.
A third study will attempt to show the equivalence of the
drug Nabi is currently testing with versions of the drug produced by Nabi’s
contract manufacturer, Dow Biopharmaceutical Contract Manufacturing Services.
Nabi said the FDA stated in reference to the original
Phase III trials that “a definitive demonstration of preventative efficacy...in
another well-designed, randomized and controlled clinical study will be needed
for licensure.” Original Phase III tests for the vaccine to prevent the common blood
infection, commonly known as Staph, had a goal of reducing the infection at 12
months after StaphVAX was taken.
Shares of Nabi, which plummeted about 40 percent after the
clinical results and manufacturing problems on other drugs were announced in
September, closed up 3/32 at $5-15/32 ahead of the news.
“We are going to take the route of designing an additional
clinical trial, which we would like not to do, and we think that since we’ve
already shown protection, it’s not something that has to be done in order to
show that,” Nabi said.
“On the other hand, we have to be realistic in moving this
thing forward into something that’s going to get approved,” he added.
He said the company is still evaluating possible
endpoints, or stated goals, for the additional trials, such as 10-month
effectiveness in patients rather than the 12-month window.
Gury said the FDA did not impose a specific endpoint on
the company. “They’ve not said to do it
in 12 months or do it with a booster, but to do it in a prospectively designed
trial,” he said.
StaphVAX creates antibodies to fight certain types of
Staph that the body would not ordinarily produce. “The antibody then creates a
triggering mechanism to alert the immune system to come along and engulf the bacteria
and remove it,” Gury said.
The company also makes WinRho for immune platelet
disorders, AutoPlex T for the treatment of hemophilia and Aloprim to treat
chemotherapy-induced hyperuricaemia, or elevated uric acid levels in the
bloodstream.
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