HPV vaccine update

[Guest guest]

The part of this i find particularly interesting is the last paragraph which

states the success of the preliminary testing of the MMR vaccine to treat the

recurring repiratory papillomas in trial patients as young as age 2. I have a

personal interest in this due to the fact my nephew was born with papillomas

on his vocal cords and has repeated laser surgeries at UCLA since the age of

1yr. He is now 4y.just a little fyi i guess, but it is remarkable to me that

with all of the controversy surrounding the vaccine they not only disregard

those

concerns and have the gall test it for other medical problems as well. Rather

discouraging as far as " our " progress, at least to me. Sorry for the rambling.

http://www.rrpf.org/rrpf/news/RRP_Newsletter_Spring03.html

HPV Vaccine Update

 

Positive results from Phase II Clinical Research Study in Pediatric RRP using

the HspE7 Vaccine for HPV

 

[The following article is based on a press release and subsequent conference

call. More details may be found at: www.stressgen.com]

On 10 June 2003, Stressgen Biotechnologies Corporation announced that results

from its Phase II trial with HspE7 showed a statistically significant

reduction in the number of surgeries for a group of 27 moderate to severe RRP

patients.

Top line data from this trial involved the interval between surgeries

following treatment with HspE7 compared to the pretreatment surgical interval,

the

primary endpoint of the trial. In the study population as a whole, there was a

mean increase of 78.6 percent in the interval between surgeries (p=0.015)

following treatment with HspE7 compared to the pretreatment surgical interval,

resulting in fewer surgeries for these patients.

Longer-term follow-up continues in this trial out to 60 weeks beyond the

initiation of treatment with HspE7. Preliminary projections of the number of

surgeries per year have been made. Among the patients estimated to have a

reduction

of at least one surgery per year as compared with the pretreatment period, it

is projected that more than 50 surgeries will have been avoided during the

year after treatment.

HspE7 was given to 27 patients age from 2-18 through a 500 mcg subcutaneous

injection administered three times over a 60-day period. Prior to study

initiation, all of the children required frequent surgeries under anesthesia in

order

to reduce the size of warts to unblock their airways. Approximately one-half

of the children enrolled in this trial had severe disease defined by a

clinical score considered by experts to correspond to severe disease. In

addition,

seven of the children in this study were known to have had papillomas in the

lungs, which is the most serious manifestation of RRP. By both of these

measures,

the children in this study presented a difficult challenge for HspE7

treatment.

This HspE7 study, Stressgen’s first for its investigational immunotherapeutic

therapy for RRP, had two objectives. The first objective & emdash; standard

for a Phase II trial & emdash; was to assess the clinical effectiveness of HspE7

in children with RRP, through the primary endpoint of the length of

post-treatment inter-surgical interval compared to median pretreatment

inter-surgical

interval. The first objective was achieved and leads to a Phase III confirming

trial. The second objective involved the establishment of a very high hurdle of

a doubling of the first inter-surgical interval, which, if achieved, might

have further accelerated the clinical program. The second objective was almost

made, thereby providing further support for a Phase III RRP program. Based on

these results and the recommendations of the expert panel that reviewed the

data, Stressgen is planning to develop a Phase III RRP program moving towards a

goal of a Biologics License Application submission to the U.S. Food and Drug

Administration (FDA) for this indication.

Stressgen has entered into a collaborative agreement with Roche for the

co-development and global commercialization of HspE7. Roche is producing

commercial

grade HspE7 to be used in the proposed Phase III RRP trial. The Phase III

trial is anticipated to start during the second half of 2004.

HspE7 is produced by Stressgen Biotechnologies Corporation

 

 

www.stressgen.com Canadian Office: #350 - 4243 Glanford Avenue , BC

Canada V8Z 4B9 Phone: (250) 744-2811 Toll Free: (800) 661-4978 Fax: (250)

744-2877

Principal Executive Office:

10241 Wateridge Circle, C200

San Diego, CA 92121 USA

Telephone: (858) 202-4900

Fax: (858) 450-6849

Merck and some other companies are also developing, primarily prophylactic,

HPV vaccines, the objective being to target a large population that are likely

to be exposed to genital HPV. We are following this work with much interest.

Since there has been therapeutic success using Mumps and MMR vaccines designed

to be preventative, it is felt that some of these HPV vaccines that target HPV

6 & 11, could be at least as effective.

[Guest guest]

In a message dated 1/2/2004 2:09:19 AM Eastern Standard Time,

erinrmos@... writes:

> It would be interesting to find out where papillomas originate. Maybe

> another monkey virus? does any one know? Its also interesting to think they

are

> injecting kids with mumps to cure it. Maybe if the child was allowed to get

> mumps they would never happen in the first place?

All the best,

" Parents should decide through informed choice, which vaccines if any should

be

given to their children "

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