December 17, 2005

Cancer vaccine has strong response in young girls

By Ransdell Pierson

NEW YORK (Reuters) - Girls aged 10 to 14 who received
GlaxoSmithKline Plc's vaccine to prevent infection with the
virus that causes cervical cancer had immune responses twice as
strong as women 15-25 years old given the vaccine, the company
said on Saturday, describing results of a late-stage trial.

Glaxo said the first published data from a Phase III trial
of its Cervarix vaccine suggest it may provide the strongest
and most-prolonged protection if given to girls at very young
ages, long before they encounter the sexually transmitted

"The concentrations of antibodies to the virus were twice
as high in the bloodstreams of the young girls," said Gary
Dubin, a senior research official at Glaxo who was the lead
author on the study.

Antibodies are immune-system proteins that seek out and
destroy bacteria and viruses. Vaccines, by introducing the body
to snippets of specific bacteria or viruses, train the body to
crank out tailor-made antibodies that attack them.

Dubin said the trial was not designed to confirm actual
effectiveness of the vaccine because few girls in the 10 to 14
age group are yet sexually active. Instead, he said the immune
response is the best "surrogate" indicator of the vaccine's
potential ability to protect them from prolonged infection with
the virus.

Results of the trial were presented at the Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in
Washington, D.C.

The Glaxo-financed trial, conducted in Europe and Russia,
involved 158 healthy girls aged 10-14 and 458 women aged 15-25
who received three doses of the vaccine over a six month

Cervarix, which has not yet been submitted for regulatory
approvals, is one of the most important experimental products
being developed by the British drugmaker. It is expected to
eventually compete with a similar Merck and Co. vaccine,
Gardasil, that is already awaiting approval from U.S. and
European regulators.

Like Gardasil, the Glaxo product blocks infection with two
strains of human papillomavirus that are responsible for about
70 percent of cases of cervical cancer. It is the second most
common fatal cancer in women.