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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?


To: Steve Fancy who wrote (5426)9/28/1998 2:38:00 PM
From: Oliver & Co  Respond to of 6136
 
"Lower-Dose Regimen Works for Protease Inhibitor"
Reuters (09/25/98)
Patients with AIDS may soon be able to take two doses of the
protease inhibitor Viracept instead of three, Agouron said
Friday. The drug maker said 80 percent of 238 patients taking a
higher, twice-daily dosage of Viracept as part of a drug cocktail
were able to lower the levels of the virus to a level that was
almost undetectable. The response was similar to that achieved
by patients taking the drug three times a day in a lower dosage.
If the drug is approved, it may erode market share now held by
Merck's Crixivan.



To: Steve Fancy who wrote (5426)9/28/1998 2:58:00 PM
From: Steve Fancy  Respond to of 6136
 
Glaxo's Ziagen, Combivir Drug
Combination Effective In Study

Dow Jones Newswires

SAN DIEGO -- A small study showed Glaxo Wellcome
PLC's (GLX) investigational anti-HIV drug Ziagen
combined with Combivir appears effective in reducing
viral load and increasing CD4 cell counts in patients who
previously received certain treatments.

In a press release Monday, Glaxo Wellcome said 28 of
39 patients, or 72%, had undetectable virus after
undergoing 16 weeks of treatment with Ziagen and
Combivir.

The patients had previously received treatment only with
monotherapy or combinations of certain nucleoside
analogue drugs, and in a few cases with certain
nonnucleoside inhibitors.

The median viral load of the 87 patients enrolled in the
study was initially 1,259 and median CD4 cell count was
506.

After 16 weeks of treatment with Ziagen and Combivir,
72% of patients had less than 400 viral copies and 54%
had less than 50 copies, Glaxo Wellcome said.

Glaxo Wellcome said median CD4 cell counts among
the patients rose to 536.

The preliminary data provides promise that the
combination of Combivir and Ziagen may effectively
supress HIV replication in patients who received
nucleoside analogues and may allow patients to preserve
future treatment options.

Nausea, malaise and fatigue, headache, vomiting and
diarrhea are the most commonly reported side effects
associated with Ziagen.

In a separate release Monday, Glaxo Wellcome and
Vertex Pharmaceuticals Inc. (VRTX) also reported a
triple therapy of Agenerase, Epivir and Retrovir
appeared effective in reducing viral load level below the
limit of detection of standard assays, of 400 copies/ml.

Glaxo Wellcome develops and markets pharmaceuticals.




To: Steve Fancy who wrote (5426)9/28/1998 2:59:00 PM
From: Steve Fancy  Respond to of 6136
 
Cell Genesys To Start New Phase II AIDS Gene Therapy Trial

Dow Jones Newswires

NEW YORK -- In a move to determine the effects of
AIDS gene therapy on an expanded patient group, Cell
Genesys Inc. (CEGE) will conduct a second Phase II
AIDS gene therapy trial.

The Foster City, Calif., gene therapy company
announced Monday that it completed enrollment for the
40-patient multi-center study.

The goal of the new trial is to determine whether Cell
Genesys' gene therapy can reduce the levels of
HIV-infected cells in patients who have responded well
to antiretroviral drugs and no longer have detectable
HIV in their blood.

Up to this point, studies have been conducted only in
patients for whom antiviral drugs have failed to eradicate
HIV in the blood. About 60 patients with detectable
levels of HIV in their blood have been treated to date
using the company's AIDS gene therapy.

Cell Genesys' commercial approach to AIDS gene
therapy involves removing immune system cells, including
T cells, from a patient's blood through standard blood
bank procedures. The T cells are sent to the company's
manufacturing facility and genetically modified to
recognize and destroy HIV-infected cells.

The gene-modified cells are then expanded in number
and frozen down in preparation for multiple gene therapy
treatments. As part of the treatments, the modified cells
are re-infused into the patient where they should target
and kill HIV-infected cells.

Many HIV-infected patients are currently being treated
with antiviral drugs which can significantly reduce the
level of HIV in the blood. However, when the drugs are
stopped, the virus typically returns in the blood within a
couple of weeks. The antiviral drugs keep the HIV from
replicating but don't eliminate the reservoirs of
chronically infected cells.

Cell Genesys said it believes its gene therapy could be
complementary to antiviral drugs since the company's
modified cells should target and destroy the reservoirs of
infected cells which harbor the HIV.

Through the new trial, Cell Genesys seeks to determine
whether its gene therapy can reduce the requirement for
long-term treatment with combinations of antiviral drugs.

In related news, the company reported updated results
from its first Phase II AIDS gene therapy trial Sunday at
the Interscience Conference on Antimicrobial Agents
and Chemotherapy Conference in San Diego, Calif.

The company detected preliminary evidence of biologic
activity, including a trend towards decreasing levels of
HIV in gastrointestinal lymphoid tissue - a primary
reservoir of HIV-infected cells - in four of five patient
who underwent biopsies of colorectal tissue following
infusion of genetically modified T cells.

"The results reported at ICAAC in patients with
persistent HIV in the blood set the stage for our second
Phase II trial," said Dale Ando, vice president of
research at Cell Genesys.

The new trial will be conducted at five sites in the U.S.

-Melanie Trottman 201-938-5287




To: Steve Fancy who wrote (5426)9/28/1998 2:59:00 PM
From: Steve Fancy  Respond to of 6136
 
Vertex Pharma/Glaxo Protease Inhibitor Effective In Study

Dow Jones Newswires

SAN DIEGO -- Vertex Pharmaceuticals Inc. (VRTX)
and Glaxo Wellcome PLC's (GLX) Agenerase HIV
protease inhibitor may be potent and generally
well-tolerated with Epivir and Retrovir in a Phase III
clinical trial.

In a press release Monday, Vertex said data from
interim 16-week data showed that 88% of patients
taking triple therapy with Agenerase, Epivir and Retrovir
achieved viral load below the limit of detection of
standard assets.

The company said an additional analysis showed that
59% of patients who received the triple therapy regimen
achieved viral load below the limit of detection of an
investigational ultrasensitive assayl.

Patients received dosages twice a day.

Vertex said side effects from Agenerase include nausea,
vomiting, fatigue and headache.

Vertex researches, develops and commercializes small
molecule drugs for viral diseases, multidrug resistance in
cancer, hemoglobin and autoimmune disorders.

Glaxo Wellcome researches, develops and markets
pharmaceuticals.




To: Steve Fancy who wrote (5426)9/28/1998 3:10:00 PM
From: Steve Fancy  Read Replies (1) | Respond to of 6136
 
A cure for colds and flu? Researchers close in

Reuters, Sunday, September 27, 1998 at 00:07
(Published on Saturday, September 26, 1998 at 08:30)

By Maggie Fox, Health and Science Correspondent
WASHINGTON, Sept 26 (Reuters) - Could there be a cure out
there not just for the common cold, but for the miseries of
flu?
Researchers at several companies are reporting this weekend
on a drug that might stop the most common cold virus in its
tracks, drugs that ease the miseries of flu, and even drugs
that can stop flu from infecting people.
They have told a meeting of the American Society for
Microbiology in San Diego that there is finally hope for
victims of flu, which not only causes a wretched week or two of
headaches, coughing and sneezing, but kills thousands every
year.
Glaxo Wellcome (ISEL:GLXO) says its drug Relenza, shown last
year to shorten a flu attack by one day, can be used almost as
a vaccine against the virus.
Tests on college students showed Relenza, known generically
as zanamivir, could reduce flu risk by 67 percent. Eleven
students who used Relenza, or 2 percent, caught a flu virus
sweeping their campus, while the 34 people, or 6 percent, who
did not take the drug caught the flu.
The drug comes in the form of a powder and is inhaled using
a pocket-sized puffer device.
Another study at the University of Virginia showed
zanamivir, given intravenously, prevented flu infection in six
out of seven volunteers.
Another drug, GS4104, developed by F. Hoffmann-La Roche
Ltd. (ZSE:ROCZ.G) and California biotechnology company Gilead
Sciences Inc. (NASDAQ:GILD), reduced a flu attack by about a third,
and relieved symptoms.
Both drugs are in Phase III clinical trials, the last stage
before a company can ask for approval from the U.S. Food and
Drug Administration (FDA).
Both target the same enzyme in the virus -- neuraminidase.
It is used by the virus to replicate itself.
The drugs attach themselves to the enzyme, effectively
clogging up the mechanism used by the virus to attack cells,
and making it helpless.
Another drug known as FluMist works as a nose spray
vaccine. FluMist, made by Aviron (NASDAQ:AVIR), has been shown to
give 93 percent protection against infection and 98 percent
protection against the ear infections that accompany flu in
many children.
Dr. Robert Belshe of Saint Louis University, who tested the
drug, thinks it will offer a much easier way to vaccinate
children and others wary of needles.
Current vaccines work fairly well, with about a 30 percent
failure rate. But there are countless strains of flu that
mutate every year and the virus kills between 10,000 and 40,000
Americans each year.
There are two other anti-flu drugs already on the market --
amantadine, made by several companies, and rimantadine, made by
Forest Pharmaceuticals. But they only fight the influenza A
strain, while Relenza and GS4104 seem to work against both
influenza A and B.
While influenza is the more serious disease, the common
cold is even harder to treat.
But researchers at Agouron (NASDAQ:AGPH) think they have a good
candidate. They have only tested their drug in test tubes, but
say it stops 46 of the more than 100 known human rhinoviruses
(HRVs), one of the major causes of colds.
"We have been able to show that this drug has shown very
potent antiviral activity against all the HRVs that we tested,"
Agouron's Dr. Amy Patick said in a telephone interview.
In more experimental results, Columbia, Maryland-based
Novavax Inc. (AMEX:NOX) reported that test tube trials of its
drug, a "nanoemulsion" known as BCTP, showed it reduced levels
of antigens for influenza A by 99.6 percent.
Antigens are the chemicals to which the immune system
responds, and are a good indicator of how much virus remains in
the system.
In a second study, mice that had BCTP and virus sprayed
into their noses stayed healthy, while three mice that got a
virus alone developed severe pneumonia and two died.
Novavax thinks BCTP might kill the virus outright and in a
second presentation to the meeting said it killed anthrax, as
well as the deadly spores spread by the anthrax bacillus.

Copyright 1998, Reuters News Service



To: Steve Fancy who wrote (5426)9/29/1998 7:05:00 PM
From: scaram(o)uche  Read Replies (2) | Respond to of 6136
 
>> Rick, do you have
any new opinions on the Remune potential? AGPH seems to have laid a lot on the line
with this drug. <<

Steve:

Nope, but I'm trying to keep ears open. I really don't think that they bet that much...... seems like it was a win-win deal..... IMNR got a better deal than they would have gotten from any pharma with an HIV-targeted sales force, and AGPH didn't pay all that much up-front for a potential block buster. Note that I don't assign great odds of success in labeling it a pbb. Would love to see data that makes me more enthusiastic, but it's hard data to come by, and will only be available upon unblinding.

Rick