http://www.newmediaexplorer.org/chris/2004/11/08/
legal_action_over_mefloquine_malaria_drug.htm
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Australian army faces legal action over mefloquine
Bob Burton
Canberra
The Australian army and Roche Products Australia face a class action after
allegations that army personnel had serious side effects after being
prescribed mefloquine hydrochloride (Lariam) as part of a research trial for
a new anti-malarial drug.
Since 1998, the Army Malaria Institute, a research organisation of the
Australian Army, has been working with the Royal Thai Army and the US Army to
trial an experimental drug, tafenoquine. In 1999, the institute, in
collaboration with SmithKline Beecham, started a trial reportedly of about
600 Australian troops serving as part of the United Nations peacekeeping
forces in Bougainville and later in East Timor. Mefloquine was used as the
comparator.
Simon Harrison, a lawyer with the Brisbane based legal firm Quinn and
Scattini, plans to file legal complaints in the next few weeks on behalf of
numerous service personnel, complaining about serious side effects from the
drug. Mr Harrison says that army personnel were not adequately informed about
the potential side effects. The legal action will allege that the plaintiffs
had depression, kidney damage, paranoia, and suicidal thoughts after taking
the drug.
The Australian drug regulator, the Therapeutic Goods Administration, requires
Roche Australia to include a four page product information sheet with
prescriptions of the drug. The current information sheet, prepared in 1998,
warns consumers who experience "depression, restlessness, confusion, feeling
anxious or nervous" to inform their doctor immediately. "Other side effects
not listed above may also occur in some patients," it states.
http://www.newmediaexplorer.org/chris/
GenVec Expands Malaria Vaccine Program Under U.S. Naval
Medical Research Center Contract
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=
104&STORY=/www/story/01-20-2005/0002865781&EDATE=
GAITHERSBURG, Md., Jan. 20 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq:
GNVC) has signed a $1.6 million contract with the Department of Defense to
manufacture an adenovector based malaria vaccine candidate for the U.S. Naval
Medical Research Center (NMRC) using GenVec's proprietary adenovector
technology and 293-ORF6 cell line based manufacturing process. The vaccine is
based on two antigens and is designed to attack multiple stages in the
lifecycle of the P. falciparum malaria parasite. The NMRC will use some of
the materials manufactured under this contract to complete preclinical
testing in preparation for a planned clinical trial, which will be executed
by the NMRC.
"We are pleased to see another vaccine candidate using GenVec's technology
move forward into the clinic," said Joseph T. Bruder, Ph.D., GenVec's
director of vector and vaccine programs. "Through our excellent collaborative
relationship with the NMRC, we hope to make significant progress against
malaria, a disease that causes over one million deaths each year, mostly
among children, and threatens the health of our troops and travelers abroad."
GenVec's vaccine program applies the Company's unique delivery technology and
293-ORF6 cell line to develop vaccines against a variety of diseases,
including malaria, HIV, dengue virus and SARS. The Vaccine Research Center of
the National Institute of Allergy and Infectious Diseases, part of the
National Institutes of Health, is currently testing a vaccine developed in
collaboration with GenVec against the virus that causes AIDS in a Phase 1
dose-escalation study. Enrollment in this first HIV clinical trial has been
completed.
Support for the manufacturing and clinical development of this adenovector
based malaria vaccine candidate is provided by the U.S. Agency for
International Development Malaria Vaccine Development Program, the U.S.
Department of Defense Military Infectious Disease Research Program, and the
Office of the Congressionally Directed Medical Research Program.
GenVec is a publicly held biopharmaceutical company focused on the
development and commercialization of novel therapies that improve patient
care in the areas of cancer and cardiac disease, and to prevent vision loss.
GenVec is also developing vaccines. The vaccines against malaria and HIV
discussed in this release have not been approved by the Food and Drug
Administration. GenVec is not responsible for the design or conduct of these
clinical trials. Additional information on GenVec is available at http://www.genvec.com
and in the Company's various filings with the Securities and Exchange
Commission.
Statements herein relating to future financial or business performance,
conditions or strategies and other financial and business matters, including
expectations regarding future programs and studies, are forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act. GenVec cautions that these forward-looking statements are subject to
numerous assumptions, risks and uncertainties, which change over time.
Factors that may cause actual results to differ materially from the results
discussed in the forward-looking statements or historical experience include
risks relating to the early stage of GenVec's product candidates under
development; uncertainties relating to clinical trials; the timing and
content of future U.S. Food and Drug Administration regulatory actions
with respect to GenVec, its product candidates, or collaborators, risks
relating to the commercialization, if any, of GenVec's proposed product
candidates (such as marketing, regulatory, patent, product liability, supply,
competition and other risks); dependence on the efforts of third parties;
dependence on intellectual property; and risks that we may lack the financial
resources and access to capital to fund our operations. Further information
on the factors
and risks that could affect GenVec's business, financial conditions and
results of operations, are contained in GenVec's filings with the U.S.
Securities and Exchange Commission (SEC), which are available at http://www.sec.gov.
These forward-looking statements speak only as of the date of this press
release, and GenVec assumes no duty to update forward- looking statements.
SOURCE GenVec, Inc.
Web Site: http://www.genvec.com
Scientists Reveal Molecular Secrets Of The Malaria Parasite
1-20-05
In an innovative project with implications
for malaria vaccine development, scientists have used genomics, proteomics
and gene expression studies to trace how malaria parasites evolve on a
molecular level as they move between their hosts and insect vectors.
That unprecedented focus on the parasites’ complex life
cycle is helping researchers understand when different genes switch on and
off as the pathogens metamorphose through seven different life stages. In
turn, that molecular-level data will benefit biomedical scientists who are
identifying new targets for vaccines that would impede the parasite during
stages when it is particularly vulnerable to intervention.
“We hope this project will help vaccine researchers find
the best targets against malaria,” says scientist Neil Hall, the first
author of the paper that appears in the January 7th issue of Science. “The
study’s findings will help scientists identify parasite genes that are
interacting with the host as well as new gene targets for vaccines that aim
to prevent parasite transmission in the mosquito.”
The study highlights the genes in four malarial species
that evolve rapidly because of “selective pressures” in the stages of their
life cycles in their mosquito vectors and in their mammalian hosts. Malaria
parasites undergo three stages in their mosquito vectors, three stages in
their vertebrate hosts and a sexual development stage during which the
parasite is transmitted between vector and host.
The Science paper represents the culmination of four
years of cooperative work by scientists at several research institutes,
including: the Wellcome Trust Sanger Institute in the U.K., where the
sequencing and genome annotation was performed on two species of rodent
malaria (Plasmodium chabaudi and P. berghei); the University of Leiden in
the Netherlands and Imperial College in England, where scientists carried
out gene expression studies; and The Institute for Genomic Research (TIGR),
in Maryland, where scientists did a comparative analysis of the two draft
genomes with those of the first rodent malaria parasite to be sequenced,
Plasmodium yoelii.
The first author of the paper is Hall, a TIGR Assistant
Investigator who did most of his work on this project while in his previous
position as a bioinformatics scientist at Sanger. He was also the first
author of the 2002 study – led by scientists at TIGR, Sanger, and Stanford
University – that presented the complete genome of Plasmodium falciparum,
the deadliest human malarial parasite.
Hall says the Science paper is important because:
* The study takes an “evolutionary approach” to
exploring how the Plasmodium genome has evolved. By comparing four
sequenced genomes (the human malaria P. falciparum and the rodent malarias
P. yoelii, P. chabaudi and P. berghei), the scientists found that the major
differences between the malarial species are found in the virulence factors
(which are at the chromosome ends) while the “housekeeping” genes are
almost totally unchanged.
* Researchers showed that the parasite genes evolve most
rapidly when they are expressed in the mammal hosts (human/mouse). That may
represent a mechanism by the parasites to repulse the attack of the host’s
immune system.
* For the first time, scientists were able to study the
protein expression of the parasite in the mosquito vector. Researchers hope
this will shed light on how the mosquito and parasite interact, and perhaps
will lead to new ways of controlling the parasite in the vector.
* Hall and Leiden scientists identified evidence of an
unusual method of gene regulation (called post transcriptional regulation)
at the transition between the vertebrate host and the mosquito. That motif
regulates proteins that are switched on as the parasite enters the
mosquito.
Hall’s group identified the gene regulation by comparing
the genes expressed in the sexual stage transcriptome with the proteomes of
both the sexual stage and a developmental stage in the mosquito. Several
genes were identified for which transcripts were detected in the sexual
stage but with protein products specific to the mosquito stage, indicating
delayed translation of transcripts from these genes.
Hall says that gene-regulation motif “is particularly
interesting because these proteins, expressed early in the mosquito, are
the target of transmission-blocking vaccines" – that is, vaccines which
raise antibodies that attack the parasite in the vector. (Such antibodies
are in the “blood meal” and still work for an hour or so after the mosquito
bites).
Another TIGR scientist who played an important role in
the project is Associate Investigator Jane Carlton, who had led the
sequencing of P. yoelii at TIGR and who has worked on Plasmodium for most
of her research career. While at the University of Florida, Carlton had led
the first large-scale gene identification project in P. berghi – including
information that was used by Leiden University researchers in their
investigation of genes that are turned on during the parasite’s
reproduction stage.
At TIGR, Carlton constructed a composite of all three
rodent genome sequences (P. yoelii, P. berghei, P. chabaudi) by aligning
them against the P. falciparum genome to create a whole-genome synteny map
of the four species. TIGR scientist Shelby Bidwell helped in the generation
of the synteny map. In collaboration with Leiden University researchers,
they were then able to generate maps that compare the degrees of similarity
among genes on P. falciparum chromosomes and its rodent-malaria
counterparts.
“The paper is significant on many levels, including the
integration of draft genome sequence data with microarray and protein
expression data,” says Carlton. “This project also shows the power of
collaboration between international institutes with different areas of
expertise. It was remarkably productive collaboration.”
The Plasmodium study was sponsored by The Wellcome
Trust, the European Union’s research directorate, and the U.S. National
Institutes of Health.
The Institute for Genomic Research (TIGR) is a
not-for-profit research institute based in Rockville, Maryland. TIGR, which
sequenced the first complete genome of a free-living organism in 1995, has
been at the forefront of the genomic revolution since the institute was
founded in 1992. TIGR conducts research involving the structural,
functional, and comparative analysis of genomes and gene products in
viruses, bacteria, archaea, and eukaryotes.
Turmeric can combat malaria, cancer virus and HIV
T. V. Padma
11 March 2005
Source: SciDev.Net
[NEW DELHI] Indian researchers are saying that turmeric, a yellow spice
used in many national dishes, has shown potential as a weapon against malaria
as well as promising effects against HIV and the virus that triggers cervical
cancer. The latest findings are of significance to developing countries where
malaria and HIV are serious public health concerns, and which bear 80 per
cent of the global burden of cervical cancer. India alone has one-third of
the world's cervical cancer cases.
Earlier studies had confirmed the anti-microbial, anti-tumour and
anti-inflammatory properties of turmeric's main component, curcumin.
Scientists at the Indian Institute of Science (IISc) in Bangalore and the
University of Michigan Medical School, United States, showed that curcumin
inhibits drug-resistant forms of Plasmodium falciparum, the parasite that
causes cerebral malaria. When they fed curcumin to mice infected with
Plasmodium bergheii, a related parasite that causes rodent malaria, the
number of parasites in the mice's blood fell by 80 to 90 per cent.
In tests, curcumin completely protected up to 29 per cent of infected
mice, say the scientists. "Curcumin may offer a novel treatment for
malarial infection," says Govindrajan Padmanabhan, scientist emeritus at IISc
and one of the authors of the research, which was published in Biochemical
and Biophysical Research Communications in January. In a separate
study, Bhupesh Prusty and Bhudev Das of the Institute of Cytology and
Preventive Oncology in New Delhi reported that curcumin could help prevent
cervical cancer, which is associated with the human papilloma virus (HPV) in
90 per cent of the cases.
The virus has two key genes - E6 and E7 - which bind to a protein in
normal human cells to make them (the cells) cancerous. Curcumin binds with
the same human protein, preventing the virus from doing so, say the
researchers in the January 2005 issue of International Journal of Cancer. In
laboratory studies, two hours after the scientists introduced curcumin to
infected cells, the viral genes began to unbind from the human protein.
Das told SciDev.Net that his institute was planning to start human trials in
two or three months. A capsule containing curcumin will be inserted into the
vagina of women infected with HPV daily for three to four weeks.
The capsule dissolves slowly, releasing the curcumin powder, which will
eventually be expelled in the urine. In a further demonstration of turmeric's
potential to help tackle killer diseases, when scientists at the Jawaharlal
Nehru Centre for Advanced Scientific Research in Bangalore 'fed' curcumin to
HIV-infected cells in the laboratory, the virus stopped replicating. They say
curcumin could be used to help formulate a combination of drugs to treat HIV
infection. Tapas Kundu, associate professor at the centre, told SciDev.Net
that curcumin stops an enzyme called p300 from performing its normal role of
controlling the activity of human genes. Because HIV integrates itself into
human genetic material, when p300 stops working, the virus can no longer
multiply.
Kundu believes the same mechanism could explain curcumin's other
anti-bacterial and anti-viral properties. The p300 enzyme belongs to a class
called histone acetylase transferase (HAT) enzymes, which scientists hope
could lead them to treatments for a variety of cancers, asthma and
neurological disorders. The findings were reported in the December 2004 issue
of Journal of Biological Chemistry.
References:
Biochemical and Biophysical Research Communications 326, 472 (2005)
International Journal of Cancer 113, 951 (2005)
Journal of Biological Chemistry 279, 51163 (2004)
On March 5, 2003, the Doctor Yourself Newsletter (
http://www.doctoryourself.com/news/v3n8.txt ) suggested a novel approach for
treating malaria, a disease that kills over two million people annually,mostly
children: have all malaria patients take megadoses of vitamin C. I am very
pleased to report that recent research has now validated this hypothesis.
"Falciparum malaria infection is associated with significant destruction of
erythrocytes. This leads to the release of toxic metabolic products, including
oxidant compounds. We measured the serum concentration of the antioxidant,
ascorbic acid, in 129 patients presenting with acute falciparum
malaria infection and in 65 healthy individuals. . . (A)scorbic acid plays a
significant role in the pathogenesis of acute falciparum malaria in adults.
Infected children also need to be given supplemental doses of ascorbate in view
of the weakness of their immune system." (Hassan GI, Gregory U, Maryam H. Serum
ascorbic acid concentration in patients with acute Falciparum
malaria infection: possible significance. Braz J Infect Dis. 2004
Oct;8(5):378-381. Epub 2005 Mar 17. )
Though not affiliated with the above authors, we have actually been
field-testing this idea for over ten years. In the early 1990's, I presented the
megadose-vitamin-C concept to some of the missionary Sisters of St. Joseph based
in Rochester, NY. The result was published in the Jan. 5, 2003 DY News http://www.doctoryourself.com/news/v3n4.txt
:
"Vitamin C is now part of the daily lives of the Myky tribe in Brazil's Goias
rainforests, thanks to the efforts of Sister Suzie Wills, SSJ and a number of
other Sisters of St. Joseph. Suzie has been very effective in getting native
people eating not only citrus fruits and berries, but also taking C powder and
tablets on a regular basis. She reports healthier children and babies, and that
infant mortality has dramatically decreased. Sister Suzie is now at Olinda, near
Recife, Brazil, but is soon expected to be headed to back to Goiania."
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