Forum: Crucell » Draadje HIV/AIDS » Pagina: 3

gogogoo 2 december 2006 10:46

quote:
Dirk R. Wijnen schreef:
Vandaag wereld aidsdag.

Vanmorgen bij het nieuws had men het er over dat men bezig is een vaccin te ontwikkelen
Daarbij kreeg een proefpersoon een shot uit een Merck-flesje.
Is dit van Merck/Crucell??

Dirk

Ik heb het ook gezien Dirk.
Ik ga er persoonlijk van uit dat dat zo is (Phase 2).
crucell.nl/Partners%20-%20General%20O...

[verwijderd] 2 december 2006 21:44

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Dr Anders Nordström, Acting Director-General
1 December 2006
World AIDS Day message

The HIV/AIDS epidemic continues to grow. Some 40 million people, their families, and their communities, are now living with HIV. Effectively tackling this epidemic remains one of the world's most pressing public health challenges.
In August this year, at the XVI International AIDS Conference, 30 000 of us came together in Toronto in reply to the Conference's call to action. That action, we agreed, must reflect a balanced mix of prevention, treatment and care. This year's World AIDS Day theme "Accountability" reminds us again of our responsibility for making the right choices.
In Toronto, I spoke on the three areas in which we had to take action: the three "Ms" of Money, Medicines and a Motivated workforce.
Money: We have made some important progress and continue to do so. For example, just over half of the latest round of grants from the Global Fund - which totalled US$846 million - will go to fight HIV/AIDS. Continued commitment is needed and resources must be used effectively. Accountability is an important theme for those who want to see the best possible results in terms of human lives.
Medicines: Our goal remains to scale up international efforts to provide universal access to prevention, treatment, care and support services.The ten-fold increase in people on treatment in sub-Saharan Africa in recent years shows that we can do it. Sub-Saharan Africa also illustrates what still has to be done: it represents 70% of the global unmet need for treatment.

We have a very long way to go still in the provision of medicines to those who need them. To be able to do that, we must also know who needs treatment and care.
The latest AIDS epidemic update from WHO and the UNAIDS Secretariat, released on 21 November, gives us the most accurate picture of the epidemic to date. HIV surveillance remains weak in almost all regions, particularly among marginalized groups. Those at highest risk—men who have sex with men, sex workers, and injecting drug users—are not reliably reached through HIV prevention and treatment strategies.
At the Toronto Conference there was a powerful drive to address the needs of those who bear the greatest burden of the AIDS epidemic - women and girls. Some 40% of new HIV infections now occur among young people aged between 15 to 24 years. The most striking increases in the number of people living with HIV have occurred in East Asia, Eastern Europe and Central Asia.
Those most at risk of exposure to HIV do not always know how to protect themselves and often do not have access to the means to do so, such as condoms, clean needles and syringes, and treatment for sexually transmitted infections. Levels of knowledge of safer sex and HIV remain low in many countries, as well as perceptions of personal risk. Even in countries where the epidemic has a very high impact, such as Swaziland and South Africa, a large proportion of the population do not believe they are at risk. Where prevention efforts decline, HIV infects more people.
Counselling and testing are essential so that people who are infected can know their status, seek care, and using their increased knowledge, change their behaviours to prevent transmission of the virus to others. Those who are tested can also use knowledge of their status to protect themselves.
A Motivated health workforce: Motivated and skilled health workers who can provide essential services are the crucial missing link in many countries. WHO's "Treat, Train Retain" plan for a healthy and well supported healthcare workforce is being developed now in 15 countries.
Prevention works but has to be focused on the needs of those most likely to be exposed to HIV, and it must be sustained. There are success stories. In 8 out of 11 of some of the world's most affected countries, HIV prevalence in the age group 15 to 24 years has declined in the past five years. We must seize on these successes and see that they are repeated.
We know that comprehensive harm reduction programmes reduce risky drug injecting practice and result in declines in HIV infection rates. Effective responses are being implemented in many countries, ranging from Brazil and China to the Islamic Republic of Iran and Indonesia. These experiences provide good models for other countries.
Another key element in the epidemic - Tuberculosis - has recently drawn increased attention with the development of an extremely drug resistant form that signals the urgent need for TB control. TB causes up to half of all deaths in people living with HIV.
The AIDS epidemic provides us with clear evidence that even some of the most complex health and development problems can be successfully addressed. To see this positive pattern repeated everywhere will take greater political will and more resources.
Our ability to be responsive to changes in the epidemic is a central factor if we are to succeed. We have to be constantly alert to shifts in the epidemic dynamic and country contexts, aware of which approaches are successful, and flexible enough to adapt our responses accordingly. We do not just need "more". We need to commit to clear sightedness about what is working and what is not - and quickly apply that knowledge.
For example, recognizing the critical role that vulnerable and marginalized populations play in the epidemic, we need to invest in models of service delivery that reach these groups, ensure equitable and quality services, and are able to provide sustainable support to the most affected communities.
We are now more than 25 years into this epidemic. People living with HIV and their communities urgently need to see tangible results. We are at a critical juncture. Just last week, Secretary-General Kofi Annan inaugurated the new joint UNAIDS/WHO building in Geneva. It is a building which now houses the HIV, TB and Malaria staff of WHO, side by side with the UNAIDS team. Nothing more clearly symbolises our determination to work as a team. It is a commitment to collaboration, and with that comes our commitment also to accountability: to all those currently living with HIV, and to all those whose lives must be protected from it.http://www.who.int/mediacentre/news/statements/2006/s17/en/index.html

[verwijderd] 4 december 2006 09:38

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De NL overheid schenkt Unicef 4 mln euro.
Morgen Unicef plaatst een order van 4 Mln bij een leids bedrijf ;)

[verwijderd] 15 december 2006 16:09

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Positive Clinical Trial Results Using GenVec's Adenovirus Vector Technology to Deliver a Candidate HIV-1 Vaccine Reported in the Journal of Infectious Diseases
Friday December 15, 8:00 am ET

GAITHERSBURG, Md.--(BUSINESS WIRE)--GenVec, Inc. (Nasdaq: GNVC - News) announced today the publication of an article and accompanying editorial reporting positive results of Phase I human trials using this HIV vaccine, in trials being conducted by the National Institutes of Health (NIH) Vaccine Research Center (VRC). It is the first published clinical research on an adenovirus-based HIV vaccine candidate.
ADVERTISEMENT

In the Phase I dose escalation trial the vaccine was tested in healthy, uninfected adult volunteers, and was found safe and well tolerated at multiple doses. This vaccine is based on GenVec's proprietary adenovirus vector technology. A single injection induced HIV-1 antigen specific T cell responses in 28 (93%) and 18 (60%) of 30 vaccine recipients for CD4 and CD8 T cells, respectively. Env-specific antibody responses were detected in 28 (93%) of 30 vaccine recipients.

The article, Phase 1 Safety and Immunogenicity Evaluation of a Multiclade HIV-1 Candidate Vaccine Delivered by a Replication-Defective Recombinant Adenovirus Vector, authored by investigators from the NIH Vaccine Research Center, the Fred Hutchinson Cancer Research Center and GenVec, appears in the December 15 issue of the Journal of Infectious Disease (JID2006:194).

In the accompanying editorial, Harriet Robinson, Ph.D., from Emory University and Kent J. Weinhold, Ph.D., from Duke University discuss the strategy being used by the NIH Vaccine Research Center to develop an HIV/AIDS vaccine, which employs a DNA vaccine to prime the immune response and GenVec's rAd5 vaccine technology to boost the response.

"This publication is an important milestone in the HIV vaccine program. We are pleased that the vaccine is well tolerated and immunogenic and has demonstrated an ability to elicit a T-cell response, which is considered to be important in the control of the disease," said C. Richter King, senior vice president of research for GenVec. "We were also pleased at the positive view of the editorial and look forward to additional data from the ongoing VCR Phase II trials, and the planned initiation of a Phase IIb efficacy trial next year."

Dirk

[verwijderd] 15 januari 2007 09:26

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www.investorvillage.com/smbd.asp?mb=4...

ARTICLE ON MRK AIDS DRUG, LOOKS LIKE BEST IN CLASS DRUG

AIDS drug offers hope, but too late for one man
By James Ricci, Times Staff Writer
January 2, 2007

A battle lost
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Reason to hope
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Related Stories
- The ones HIV left in limbo
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2006 was destined to be the year Warren Ratcliffe lost his desperate race to survive AIDS, and the year Mark McClelland appeared, finally, poised to win his.

The two Bay Area men were among an estimated 40,000 Americans whose illness could not be controlled by modern HIV drugs because they'd developed a bedeviling resistance to them. Known as "salvage therapy" patients, they had only one hope: that a complicated and ever-changing witch's brew of existing medications, aimed at stalling the famously mutational virus, would keep them alive long enough for entirely new drugs to arrive via the pharmaceutical research pipeline.

In 2006 just such a drug — one that some researchers are calling "truly phenomenal" — did come along, in time, doctors hope, to save the 45-year-old McClelland but too late for Ratcliffe, who was overtaken by AIDS-related cancer and died April 27 at age 58.

The new drug, called an integrase inhibitor, was a highlight of the summer's annual international AIDS conference in Toronto. Newly published clinical studies showed that it, in combination with two existing drugs, reduced the virus to undetectable levels in nearly 100% of HIV patients taking, for the first time, a regimen targeting their condition. It had a similar effect on the virus in up to 72% of salvage therapy patients.

"They tested it on some people who were in deep, deep salvage therapy, and even those people did remarkably well," said Dr. Steven Deeks, a UC San Francisco salvage therapy authority who treated Ratcliffe and still treats McClelland. "It seems to be a truly phenomenal drug that everyone is sort of a little bit in awe of right now and is changing the whole way we think about the management of these patients."

The drug essentially prevents the virus from integrating its DNA with that of a host's cells, thus short-circuiting its ability to replicate itself.

McClelland had several friends in salvage therapy who were part of the integrase inhibitor studies. "They all did extremely well," he said.

The knowledge of how they fared was immensely encouraging to him. And his own recent negative experience propelled him in the same direction.

In October, he came down with a fungal infection that took advantage of his lowered immune defenses.

"It was semi-serious but treatable," he said. "Getting sick hit me emotionally, however. I was just coasting along, and it was an opportunistic infection, and I hadn't had one of those in 11 years. And that was tough and gave me some renewed determination."

What was more, McClelland's count of infection-fighting T-cells, a principal indicator of immune system compromise, hit zero. "It wasn't too different from four, which I've hit before, but there's something about hitting zero that was a little upsetting."

Ratcliffe could not be included in the clinical studies of the integrase inhibitor. Kaposi's sarcoma, the early AIDS epidemic's portentous and deadly calling card, was overwhelming him.

"Warren really couldn't qualify for the drug, because his Kaposi's was progressing and because he had pretty significant side effects from the chemotherapy," Deeks said. "Mark is doing well, however, and I'm trying to get him on the integrase inhibitor right now. We're trying to get as many people in our research cohort as possible on this."

The new drug is on track for FDA approval by mid-2007, but its manufacturer, Merck & Co., is making it available sooner to patients in desperate straits.

Ratcliffe and McClelland were featured last January in a Times article about their unlucky subgroup and the obscure corner of AIDS treatment it occupies.

Like most others in their category, they had the misfortune of being diagnosed with HIV when single-drug treatment, called monotherapy, was the only help available. With monotherapy, the virus had to mutate past only one drug, which made a patient resistant to that medication and all others of its type.

Multi-drug therapy, which became available a decade ago, usually presents HIV with too many obstacles for it to mutate past. This therapy became the gold standard of treatment, suppressing the virus and allowing patients to live normal lives.

The multi-drug "cocktail" failed to work for monotherapy veterans like Ratcliffe and McClelland, because in them, the virus had already become resistant to one of the cocktail's components and was more likely to resist other drugs in the mix, as well.

Ratcliffe's deterioration and death just as a potentially saving drug was becoming available has inflicted an added measure of pain on Alex Kazan, his domestic partner of 10 years and friend of 25.

"Watching him go was pretty difficult, because he was such a wonderful, caring person," Kazan said. "You wonder why he couldn't have been spared. I thought I'd grow old with him, but he just didn't hit the right part of the wave, I guess."

Suffering from effects of the disease and the toxicity of the pharmacist's catalog of medications he took over the years was a constant theme in Ratcliffe's life. It too had a special poignancy for the 55-year-old Kazan, himself a veteran of monotherapy, albeit one whom multi-drug therapy has kept in good heath.

"I guess there was always a little bit of guilt that I was doing better than he was," Kazan said. "But he was always excited about me doing better. He probably wouldn't have gone through all the heroics, in terms of all the therapies, if it wasn't for me. He took care of me. He fought so hard and rarely complained."

In late March, his once-fit body reduced to boniness by chemotherapy, Ratcliffe admitted himself to a hospital because of a persistent, intense headache. Over the next month, infections appeared in his brain and, knowing the end was near, he decided to die at home.

"They thought he'd make it another eight or nine weeks, but he made it only five days," Kazan recalled.

At a memorial service July 15, the day before Ratcliffe would have turned 59, the 150 people in attendance heard the Mississippi native and Navy veteran of the Vietnam War memorialized as a homebody, a perfectionist, an expert cook and gardener, a man who looked after elderly friends, remained close to his four siblings and was especially kind to children.

"Before he died, he sat down his goddaughter and other kids he knew and told them that after he was gone, they had to go on living," Kazan said. "And he sat me down too and said that I had to go on. I'm not sure I have. Not yet."

It is in the hope of preventing similar loss that Deeks and other researchers have such profound interest in the new AIDS drug, especially in combination with other new drugs they hope to have available by the end of this year.

His recent infection convinced McClelland that he has to begin taking the new integrase inhibitor — probably in combination with two other new drugs — sooner rather than later, probably in February.

He's had promising medicine regimes before, and all of them ended up disappointments, "but this seems to be so much better than anything that's come before," he said.

"

[verwijderd] 16 januari 2007 22:23

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DJ Novavax Says It Has Improved HIV/AIDS Vaccine >NVAX

DOW JONES NEWSWIRES

Novavax Inc. (NVAX) said Tuesday it has "significantly" enhanced the quality and purity of its virus-like particle vaccine for HIV/AIDS.

Rockville, Md.-based Novavax said pre-clinical studies are underway using the new HIV-1 vaccine, and planning has begun to move the new vaccine to human clinical trials.

Novavax said it is working with scientists from the University of Alabama-Birmingham, Emory University and Harvard Medical School under funding from a grant from the National Institutes of Health.

Novavax shares rose 12% to $4.45 in Tuesday morning trade.

-Gabriel Madway; 415-439-6400; AskNewswires@dowjones.com

[verwijderd] 17 januari 2007 09:22

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quote:
Dirk R. Wijnen schreef:
DJ Novavax Says It Has Improved HIV/AIDS Vaccine

Novavax And Collaborators Significantly Improve VLP Vaccine For HIV/AIDS
Main Category: HIV / AIDS News
Article Date: 17 Jan 2007 - 0:00 PST
Novavax Inc. (Nasdaq: NVAX) said today that it has significantly enhanced both the quality and purity of its virus-like particle (VLP) vaccine for HIV/AIDS. Pre- clinical studies are under way using the improved HIV-1 vaccine, and planning has begun to advance the new vaccine to human clinical trials.

Novavax is working in collaboration with scientists from the University of Alabama-Birmingham, Emory University and Harvard Medical School under funding from a grant from the National Institutes of Health.

"This advance demonstrates the flexibility and broad applicability of our VLP platform technology and the skill of our development team in engineering customized vaccines," said Novavax President and Chief Executive Officer Dr. Rahul Singhvi. "After demonstrating immunogenicity in pre-clinical studies with our VLP vaccines for influenza, we are eager to develop VLP vaccines against other infectious diseases."

Early versions of Novavax's HIV vaccine were successful in triggering immune responses in pre-clinical studies. However, Novavax scientists and its collaborators recently discovered a way to optimize the expression of the HIV- 1 envelope, which is a principle target for immunity in humans.

"The scientific community has been searching for a way to create an HIV/AIDS vaccine based on the HIV-1 viral envelope with a natural three- dimensional structure to trigger a protective immune response," said Dr. Gale Smith, Novavax's Vice President of Vaccine Development.

"A major scientific challenge we face is the genetic diversity of HIV. A VLP-based vaccine for HIV has the potential to be highly immunogenic due to the particle nature of the vaccine and, because its structure is correct, could lead to a vaccine protective against a much wider diversity of viruses," he said.

Virus-like particles mimic the natural virus in structure but do not contain a virus's genetic material required for replication or infection. When inoculated into the body, these particles have the ability to trigger strong immune responses that are capable of protecting against viral infection.

According to the World Health Organization, an estimated 39.5 million people worldwide are infected with HIV, the virus that causes AIDS, and last year alone 2.9 million people died of AIDS-related illnesses. Public health officials agree that an effective vaccine will be the best way to halt the AIDS epidemic.
www.medicalnewstoday.com/medicalnews....

[verwijderd] 19 januari 2007 01:35

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Thursday, 18 January 2007

HIV vaccine trial needs more people

Katrina Fox

Researchers are calling for last-minute volunteers to Sydney’s HIV vaccine trial which is due to end on February 15.

The Sydney study is part of a global multi-centre trial which aims to recruit a total of 3000 volunteers. Since the initial call-out in May last year, the local trial, which is taking place at St Vincent’s Hospital in Darlinghurst, screened around 25 people and have so far got only about 16 on the study. “The response was lower than we hoped for,” Dr Tony Kelleher, who is heading up the trial, told SX this week. “We hoped to recruit 50 to 100 people, but reassessed this given the timeframe.”

Kelleher said Sydney starting later than other sites in the world was one of the reasons why the numbers were lower than expected, as well as the fact that those who receive the vaccine would stand an 80 per cent chance of getting a false positive HIV result which will last at least eighteen months. “If they travel to developing countries or have business interests there, it can cause hassles so I think a lot of people were put off by the chance of having a false positive,” Kelleher said.

Developing countries, including places like Thailand, use less sophisticated algorithims to test for HIV which do not distinguish between a false positive and an actual positive HIV diagnosis. “The only reason for going in this trial is an altruistic one, so it’s a valid reason to decline,” Kelleher added.

Anyone wishing to take part in the trial should call Rebekah Puls on (02) 9385 0872 or visit www.stepstudy.com.au before February 15.
www.evolutionpublishing.com.au/sxnews...
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Who is developing the vaccine?
The vaccine was developed by the research arm of the international pharmaceutical company Merck & Co. Inc. In the Americas, human trials of the vaccine have been run in collaboration with the HIV Vaccines Trial Network (HVTN), which is a research network funded by the US National Institutes of Health.

What is the vaccine being tested?
The Study Vaccine is called Merck Adenovirus 5 HIV-1 gag/pol/nef trivalent vaccine, sometimes shortened to MRKAd5.
Adenovirus is a type of respiratory (common cold) virus. It is weakened in the vaccine construct so that it does not cause colds or sore throats.
To make the vaccine, three synthetic HIV genes are inserted into the weakened adenovirus. The vaccine “teaches” the immune system to recognise these fragments of artificial HIV and to mount a response against them.
www.stepstudy.com.au/main.htm
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Uhmm...zie ook de postings van Dirk en Josti5 in de malariadraad:
www.iex.nl/forum/topic.asp?forum=228&...

[verwijderd] 22 januari 2007 12:01

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Estimating the Benefit of an HIV-1 Vaccine That Reduces Viral Load Set Point

Swati B. Gupta,1 Lisa P. Jacobson,3 Joseph B. Margolick,3 Charles R. Rinaldo,2 John P. Phair,4 Beth D. Jamieson,5 Devan V. Mehrotra,1 Michael N. Robertson,1 and Walter L. Straus1
1Merck Research Laboratories, West Point, and 2University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania; 3The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; 4Howard Brown Health Center and Feinberg School of Medicine, Northwestern University, Chicago, Illinois; 5David Geffen School of Medicine, Los Angeles, California

Vaccines designed to induce cell-mediated immune responses against human immunodeficiency virus (HIV)–1 are being developed. Such vaccines are unlikely to provide sterilizing immunity but may be associated with reduced viral set points after infection. We modeled the potential impact of a vaccine that reduces viral set point after infection, using natural history data from 311 HIV-1 seroconverters. Log-normal parametric regression models were used to estimate the log median time to events of interest. Relative times were estimated for those with viral load set points of 30,000 copies/mL (reference group) versus those with lower viral set points. The time to key clinical events in the course of HIV-1 disease progression was significantly extended for those with viral set points 0.5–1.25 log10 copies/mL lower than the reference group. By quantifying the anticipated clinical benefits associated with a reduction in viral set point, these findings support the use of virologic end points in HIV-1 vaccine trials.

www.journals.uchicago.edu/JID/journal...

Received 2 March 2006; accepted 3 October 2006; electronically published 5 January 2007.
Potential conflicts of interest: S.B.W., D.V.M., M.N.R., and W.L.S. are employees of Merck Research Laboratories; however, no product of Merck is evaluated in this research. L.P.J. had a consultancy with Merck Research Laboratories for the analysis of participants in the Multicenter AIDS Cohort Study database.
Presented in part: XVI International AIDS Conference, 13–18 August 2006, Satellite Meeting: Viral Load as a Surrogate Marker for AIDS Vaccine Efficacy, 13 August 2006 (oral presentation); Conference on Retroviruses and Opportunistic Infections, Denver, Colorado, 5–9 February 2006 (abstract G-110, poster 480).
Financial support: Merck Research Laboratories, Merck and Co. The Multicenter AIDS Cohort Study is funded by the National Institute of Allergy and Infectious Diseases (grants UO1-AI-35042, 5-MO1-RR-00722 [GCRC], UO1-AI-35043, UO1-AI-37984, UO1-AI-35039, UO1-AI-35040, UO1-AI-37613, and UO1-AI-35041), with additional supplemental funding from the National Cancer Institute and the National Heart, Lung, and Blood Institute.
*****************************
XVI International AIDS Conference, 13–18 August 2006
www.iex.nl/forum/topic.asp?forum=228&...

[verwijderd] 22 januari 2007 20:04

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Wednesday, January 18, 2006

International HIV/AIDS Trial Finds Continuous Antiretroviral Therapy Superior to Episodic Therapy

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), today announced that enrollment into a large international HIV/AIDS trial comparing continuous antiretroviral therapy with episodic drug treatment guided by levels of CD4+ cells has been stopped.

Enrollment was stopped because those patients receiving episodic therapy had twice the risk of disease progression (the development of clinical AIDS or death), the major outcome of the study.
NIAID made the decision to halt enrollment in collaboration with the study’s Executive Committee and following a recommendation received from an independent Data and Safety Monitoring Board (DSMB). The DSMB, charged with regularly evaluating data and safety issues during the multi-year trial, conducted a review of the interim study data in early January.
The trial, known as Strategies for Management of Anti-Retroviral Therapy, or SMART, was designed to determine which of two different HIV treatment strategies would result in greater overall clinical benefit. HIV-positive volunteers were assigned at random to either a viral suppression strategy, in which antiretroviral therapy (ART) was taken on an ongoing basis to suppress HIV viral load; or a drug conservation strategy, in which ART was started only when the levels of key immune cells, called CD4+ cells, dropped below 250 cells per cubic millimeter (mm3). Volunteers in the drug conservation group were taken off ART—with the aims of reducing drug side effects and preserving treatment options—whenever their CD4+ cells were above 350 cells/mm3. (For more details see www.smart-trial.org).
The trial involved an international collaboration of 318 clinical sites in 33 countries. It began enrollment in January 2002 and had successfully recruited more than 90 percent of its target of 6,000 participants: as of January 11, 2006, when enrollment was stopped, 5,472 volunteers had joined the study.

www.nih.gov/news/pr/jan2006/niaid-18.htm

[verwijderd] 24 januari 2007 02:25

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Crunch time for AIDS vaccine trials nears in 2008
By Ben Hirschler Tue Jan 23, 11:31 AM ET

DAVOS, Switzerland (Reuters) - The hunt for a vaccine against AIDS is about to enter a critical stage, with results in 2008 from large-scale clinical trials of two candidates set to determine the future direction of research.

Although there is a good chance that neither experimental vaccine will provide comprehensive protection, Seth Berkley, head of the nonprofit International AIDS Vaccine Initiative, is optimistic scientists are on the road to developing a viable shot.

Even if today's vaccines reduce HIV infection rates by only a little, he is confident this would provide a springboard for more effective next-generation products.

HIV is uniquely difficult to vaccinate against, because the virus infects the very immune system cells that are usually stimulated by a vaccine.

Highest hopes are pinned on a vaccine from Merck & Co. Inc.. Expectations are lower for a rival product from Sanofi-Aventis and VaxGen Inc.

"Next year is a pretty important year," Berkley said in an interview ahead of the World Economic Forum in Davos.

"If we have an intermediate result, it is still very, very important, because it allows us to validate the animal models and really improve on it."

If the Merck vaccine does not work at all, then other approaches will have to be pursued.

The AIDS virus infects around 40 million people globally, most of them in sub-Saharan Africa. It killed an estimated 2.9 million in 2006, according to UNAIDS, the U.N. program on HIV/AIDS.

The two vaccines now in advanced human testing work by producing cellular immunity, and Berkley said more effort was needed to research other approaches such as neutralizing antibodies.

Nonetheless, he is convinced strides are being made in the laboratory and in the growing number of clinical trials underway in both developed and developing countries.

"Do I think we are going to solve this at the end of the day? Absolutely," Berkley said.

"If you go back 10 years, it was as bleak as could be. Ten years later, we have a wide pipeline; we have multiple efficacy trials; everybody making vaccine is considering the needs of the developing world; there is political leadership and there has been a 500 percent increase in money."

groeten uit Japan.
Biocon

[verwijderd] 24 januari 2007 19:35

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Bush in State of Union Address Calls for Continued Funding for International HIV/AIDS, Malaria Programs

During his State of the Union Address, President Bush Discussed How The President's Emergency Plan For AIDS Relief (PEPFAR) Is Meeting His Commitment Of $15 Billion Over Five Years To Support Treatment For 2 Million People, Prevention Of 7 Million New Infections, And Care For 10 Million People. PEPFAR is the largest international health initiative in history dedicated to a single disease. PEPFAR works worldwide, but targets 15 focus countries that are home to approximately half of the world's 39 million HIV-positive people: Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam, and Zambia.

Since First Providing Antiretroviral Treatment In January 2004, PEPFAR Has Supported This Life-Saving Treatment For Approximately 822,000 People Living With HIV/AIDS. This is taking place through bilateral programs in PEPFAR's 15 focus countries in sub-Saharan Africa, Asia, and the Caribbean. Of the 822,000 individuals receiving treatment through PEPFAR, 61 percent are women and 9 percent are children age 14 and under.

PEPFAR Is Supporting The Leadership Of Local Communities. PEPFAR works with partners in host nations to build local capacity in order to sustain prevention, treatment, and care efforts long after the initial five years of the Emergency Plan. Over 80 percent of PEPFAR partners are indigenous organizations.
PEPFAR Is Supporting Innovative Partnerships To Train Local Health Care Professionals. For example, a PEPFAR initiative launched in May 2006 places health care professionals from the Ethiopian Diaspora community in volunteer assignments in Ethiopia to train and work side-by-side with Ethiopian counterparts. This initiative will use a new database to identify qualified professionals from the Diaspora to help Ethiopia's HIV/AIDS campaign.
PEPFAR's New Partner Initiative (NPI) Has Awarded Its First Round Of Grants For HIV/AIDS Prevention And Care. President Bush launched the $200 million New Partners Initiative on World AIDS Day 2005. On World AIDS Day 2006, the first round of 23 grants was awarded to organizations in the U.S. and Africa for up to $72 million over three years. These organizations will work in 13 of PEPFAR's 15 focus countries.
The NPI Is Identifying And Supporting Organizations Providing Health Care In The Developing World, Including Faith-Based And Community Organizations, To Achieve Local Ownership And Long-Term Sustainability.
The U.S. Supports The Most Diverse Prevention Portfolio Of Any International Partner. In addition to the ABC (Abstain, Be faithful, and the correct and consistent use of Condoms) approach, the U.S. supports programs that focus on prevention of mother-to-child transmission, on blood safety and safe medical injections, on injecting drug users, on HIV-discordant couples, on alcohol abuse, and on other key issues, including gender-specific programs.
The U.S. Leads The World In Its Support Of The Global Fund To Fight AIDS, Tuberculosis, And Malaria. President Bush made the Fund's founding contribution, and the United States has pledged over $2 billion through 2008 – far more than any other nation.

The Administration Is Working To Address Americans Living With HIV/AIDS And To Prevent New HIV Infections. Of the approximately 40,000 new transmissions occurring annually in the United States, about half are spread by individuals unaware they are infecting others. The number of AIDS cases is especially high in the African-American, Hispanic, and gay communities, as well as among intravenous drug users and prisoners.
The President And Mrs. Bush Have Called For HIV Tests To Become A Routine Part Of Care So All Americans Know Their Status. The HHS Centers for Disease Control and Prevention (CDC) have released guidelines to physicians recommending routine voluntary HIV testing as a part of regular medical care for all people between the ages of 13-64, and annual screening for those at high risk.
Between 2001 And 2006, The Administration Has Devoted More Than $74 Billion To Treatment And Care, Increasing Annual Treatment Funding By 37 Percent. In addition, the Administration has devoted more than $15 billion to HIV/AIDS research to help develop new methods of treatment and prevention, increasing annual research funding by 20 percent. The President’s 2007 Budget requested an additional $15 billion for HIV/ AIDS treatment and care and $3 billion more for research.
The President's 2007 Budget Requested $93 Million To Purchase And Distribute Rapid HIV Test Kits That Will Facilitate Testing Of Approximately 3 Million Additional Americans. Of the approximately 1 million people infected with HIV, an estimated 250,000 are unaware they carry the virus. Rapid HIV test kits will be directed at communities with the highest rates of newly discovered HIV cases, including prisoners and intravenous drug users.
In December 2006, President Bush Signed The Ryan White HIV/AIDS Treatment Modernization Act Of 2006 Into Law. This important legislation reauthorized the Ryan White CARE Act and provides life-saving and life-extending services to people living with HIV who would otherwise have little or no access to care. It also provides more flexibility to direct funding to areas of greater need, and expands resources for women, infants, and children with HIV/AIDS.
www.whitehouse.gov/infocus/hivaids/
**************************************

State of the Union: HIV/AIDS and Malaria

www.kaisernetwork.org/health_cast/hca...

[verwijderd] 25 januari 2007 11:43

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24 January 2007

AIDS Vaccine Development: From Basic Research to Product Delivery

The International AIDS Vaccine Initiative is pleased to announce the publication of AIDS Vaccine Development: Challenges and Opportunities, one of the most comprehensive overviews of AIDS vaccine development published to date. This 140-page series of mini-reviews presents the scientific hurdles that have impeded the search for an effective AIDS vaccine and discusses novel research approaches to accelerate its progress.
Today, a quarter of a century into the global AIDS epidemic, we still have not been able to find a solution to effectively fight HIV. Prevention research has expanded significantly in recent years, with more funding available, and with greater participation of scientists, organizations and industry partners worldwide. New prevention technologies have the potential to change the course of the epidemic, and this is particularly true for an AIDS vaccine. Even a modestly-effective AIDS vaccine could reduce the number of new infections over a decade by one-third, savings tens of millions of lives worldwide.
AIDS Vaccine Development: Challenges and Opportunities examines:
the epidemiological profile of the current pandemic
the characteristics of an ideal AIDS vaccine
the pre-clinical vaccine design challenges, including strategies for developing candidates that elicit broadly-neutralizing, cellular and mucosal immune responses
issues facing the advancement of vaccine candidates to large-scale efficacy clinical trials
hurdles in vaccine manufacturing, regulatory oversight and global delivery.
Leading experts in AIDS vaccine research have contributed to this series of mini-reviews, covering the entire scope of AIDS vaccine development, from basic research to product delivery. The book is intended to advise today's scientists, immunologists, virologists and public health specialists on the current challenges and future direction of AIDS vaccine development.

www.iavi.org/viewfile.cfm?fid=43834

Met medewerking van o.a. Jaap Goudsmit

II. What Does a Vaccine Need to Do?

Chapter 4: CTL-Based Vaccines: Evidence for Efficacy in Animal Models and Humans

www.horizonpress.com/hsp/books/hivv.html

[verwijderd] 26 januari 2007 09:22

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.....paar linkjes erbij:

Draadje Crucell en AIDS vaccin (PB op yahoo)
The work, funded by a $19.2 million grant from the NIH, was reported online Sunday in the journal Nature. In Leiden, the Netherlands, Crucell's chief scientific officer, Jaap Goudsmit, said the vaccine could be in human tests by late 2007, adding the technology can be adapted for malaria, tuberculosis and other vaccines.
www.iex.nl/forum/topic.asp?forum=228&...

Draadje art. Nature
Hexon-chimaeric adenovirus serotype 5 vectors circumvent pre-existing anti-vector immunity
www.iex.nl/forum/topic.asp?forum=228&...
Vaccines: Engineering immune evasion
www.iex.nl/forum/topic.asp?forum=228&...

Draadje Publicatie Crucell Advac
Immunogenicity of heterologous prime-boost regimens involving recombinant adenovirus serotype 11 (ad11) and ad35 vaccine vectors in the presence of anti-ad5 immunity.
www.iex.nl/forum/topic.asp?forum=228&...

Draadje Gates<>Accelerate HIV Vaccine Development
www.iex.nl/forum/topic.asp?forum=228&...

Draadje IAVI grants Harvard license to use AdVac®....
The International AIDS Vaccine Initiative (IAVI) and Beth Israel Deaconess Medical Center (BIDMC) jointly announced an agreement whereby IAVI will provide BIDMC researchers with a non-exclusive, non-commercial research and development license to use AdVac® technology, an adenovirus-based vaccine production technology, for AIDS vaccine development.
Under the terms of the agreement, IAVI will offer the use of the technology at no cost to BIDMC. The AdVac® technology was licensed by IAVI from Crucell, a Dutch biotechnology company. IAVI and BIDMC will jointly monitor progress made by the use of the technology for potential application to the AIDS vaccine field. BIDMC is a major teaching hospital of Harvard Medical School.
www.iex.nl/forum/topic.asp?forum=228&...

Draadje PB Nieuw Contract voor Crucell m.b.t. HIV
Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) announced today that it has secured a US$ 16.2 million contract from the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health (NIH), for the design and development of an HIV vaccine. The contract supports a collaborative program with the Beth Israel Deaconess Medical Center at Harvard Medical School and Charles River Laboratories Inc.
The program focuses on the use of live viral vectors for the design and development of an HIV vaccine. A number of HIV genes will be tested for insertion into the vector, with the best antigens being selected for development into products suitable for phase I and II clinical trials in humans. The program will be supported by the NIAID's Vaccine Research Center (VRC), which will offer expertise on antigen design.
The contract provides for a full cost reimbursement plus a fixed-fee. The program will be fully covered up until the commencement of clinical trials. Further, the NIAID HIV Vaccine Trials Network has expressed interest in performing clinical trials as soon as preclinical tests are completed and a clinical lot is available.
www.iex.nl/forum/topic.asp?forum=228&...

Draadje Mymetics:NIH Plan to Test HIV-AIDS vaccine...
Mymetics' HIV-AIDS prophylactic vaccine candidate program combines the Company's HIV-1 gp41-based immunogen expertise with virosome technology developed by Pevion Biotech AG (Switzerland), a spin-off from Berna AG and Bachem AG. Virosome-based vaccines are market-approved, stable lipidic structures that act as carriers for peptides or proteins toward which an immune protection is desired. Virosomes have a high safety profile with few side effects and have already been distributed by Pevion Biotech AG and administered to millions of people around the world.
www.iex.nl/forum/topic.asp?forum=228&...

[verwijderd] 26 januari 2007 18:06

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Clin Microbiol. 2007 Jan 24; [Epub ahead of print]
Measurement of HIV-1 Viral Burden Utilizing Dried Spots of Whole Blood, Plasma and Mother's Milk Collected on Filter Paper.

Ayele W,
Schuurman R,
Messele T,
Dorigo-Zetsma W,
Mengistu Y,
Goudsmit J,
Paxton WA,
de Baar MP,
Pollakis G.

Ethio-Netherlands AIDS Research Project, Addis Ababa, Ethiopia, Primagen, Amsterdam, Department of Virology, University Medical Center Utrecht Utrecht, Regional Microbiological and Serological Laboratory, Hospital Hilversum, Hilversum, The Netherlands, Department of Microbiology, Immunology and Parasitology, Faculty of Medicine, Addis Ababa University, Ethiopiam, Crucell Holland B.V., Leiden, The Netherlands, Department of Human Retrovirology, University of Amsterdam, Amsterdam, The Netherlands.

We studied the use of dried spots of bodily fluids (plasma, whole blood and mother's milk) on filter paper as a way of sample collection and storage for HIV-1 viral load testing under stringent field conditions. Plasma placed directly in lysis buffer, customarily used for viral load assays, was used as the comparison in all our experiments. Utilizing reconstruction experiments we demonstrate no statistical differences in determining viral loads in plasma and mother's milk spotted on filter paper or placed directly in lysis buffer. We identify that the addition of whole blood directly in lysis buffer was unreliable and could not be considered a feasible option. On the contrary, viral load measurements in whole blood spotted onto filter paper correlated with both plasma viral load values on filter spots or in lysis buffer (Pearson correlation coefficient 0.7706 and 0.8155 respectively). In conclusion, dried spots from plasma, whole blood or mother's milk provide a feasible way for collection, storage and shipment of samples for subsequent viral load measurement and monitoring. Virus material spotted and dried on filter paper is an inexpensive good alternative way of collecting patient material to monitor HIV-1 viral load. Measuring HIV-1 burden from whole blood dried on filter paper provides a suitable alternative for low technology settings with limited access to refrigeration as can be identified in Sub-Saharan Africa.
PMID: 17251400 [PubMed - as supplied by publisher

www.ncbi.nlm.nih.gov/entrez/query.fcg...

[verwijderd] 27 januari 2007 08:39

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Vaccinaties redden miljoenen levens

,,Geen enkel kind zou de toegang tot levensreddende inentingen mogen worden ontzegd.''

© EPA
Bekijk de pagina uit de krantDe door de Gavi-alliantie betaalde vaccinatieprogramma s hebben in de afgelopen zes jaar 2,3 miljoen vroegtijdige overlijdens voorkomen.

Het succes van de vaccinatieprogramma's van de Gavi-Alliantie blijkt uit gegevens van de Wereldgezondheidsorganisatie (WHO) die op het World Economic Forum in Davos werden bekendgemaakt.

,,Gavi en zijn partners bewerkstelligen een ommekeer in de gezondheid van kinderen'', zei Melinda Gates, co-voorzitter van de Bill and Melinda Gates Foundation, die tot dusver anderhalf miljard dollar heeft bijgedragen. ,,Toen Gavi werd opgericht, was de vaccinatiegraad in de arme landen aan het dalen. Nu staat hij op een recordpeil.''

De Gavi-Alliantie kwam in 2000 tot stand op de jaarvergadering van het World Economic Forum. Ze omvat regeringen van een aantal rijke en arme landen, de WHO, Unicef, de Wereldbank, de vaccinatie-industrie, research-instellingen, ngo's en de Gates-stichting.

Sinds haar ontstaan heeft de alliantie 2,6 miljard dollar bijgedragen in steun aan nationale inentingsprogramma's in zeventig ontwikkelingslanden. Volgens de WHO zijn met dat geld 28 miljoen kinderen ingeënt tegen difterie, tetanus en kinkhoest, wat de vaccinatiegraad voor die ziekten van 63 op 77 procent bracht. Verder kregen 128 miljoen kinderen vaccins tegen onder meer hepatitis B en gele koorts. Daardoor is het aantal ontwikkelingslanden waar vaccins tegen hepatitis B worden toegediend, gestegen van 15 tot 61.

,,Gavi heeft aangetoond dat met de gepaste middelen en leiderschap verregaande vooruitgang op gezondheidsvlak in de arme landen mogelijk is'', zei Bill Gates. ,,We moeten op dit succes voortbouwen. Geen enkel kind zou de toegang tot levensreddende inentingen mogen worden ontzegd.''

Ondanks de geboekte vooruitgang waren in 2005 naar raming 28 miljoen kinderen in de ontwikkelingslanden niet ingeënt en stierven in dat jaar 28 miljoen kinderen aan ziekten die met vaccinatie voorkomen konden worden. De WHO en Unicef ramen dat in de komende tien jaar een bijkomend bedrag van 10 tot 15 miljard dollar nodig zal zijn voor vaccinatieprogramma's.

[verwijderd] 27 januari 2007 10:24

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quote:
Advize schreef:
Ondanks de geboekte vooruitgang waren in 2005 naar raming 28 miljoen kinderen in de ontwikkelingslanden niet ingeënt en stierven in dat jaar 28 miljoen kinderen aan ziekten die met vaccinatie voorkomen konden worden. De WHO en Unicef ramen dat in de komende tien jaar een bijkomend bedrag van 10 tot 15 miljard dollar nodig zal zijn voor vaccinatieprogramma's.

28 miljoen kinderen, achtentwintig miljoen............................

GAVI Alliance Results update: Saving lives, strengthening health systems

Melinda French Gates, Co-Chair, Bill & Melinda Gates Foundation, USA
William H. Gates III, Chairman, Microsoft Corporation, USA
Julian Lob-Levyt, Executive Secretary, GAVI Alliance
Moderated by
Mark Adams, Head of Communications World Economic Forum
Video via:
video.google.com/googleplayer.swf?doc...

www.weforum.org/en/events/AnnualMeeti...

[verwijderd] 27 januari 2007 10:59

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Deciphering AIDS Vaccines

An anthology of VAX and IAVI Report articles explaining key concepts in AIDS vaccine research and clinical trials
The articles in this anthology have been carefully selected to include information regarding all aspects of the AIDS vaccine field and to help the reader understand more about the science of AIDS vaccines and the clinical trials process, as well as alternate HIV prevention strategies and other vaccines that may provide lessons for the AIDS vaccine field.

Understanding..... the science of AIDS vaccines.
Understanding..... AIDS vaccine clinical trials

www.iavireport.org/specials/vax.antho...

[verwijderd] 29 januari 2007 10:09

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Gene Therapy Of AIDS
Main Category: HIV / AIDS News
Article Date: 29 Jan 2007 - 0:00 PST

Specialists of the V.A. Engelgardt Institute of Molecular Biology, Russian Academy of Sciences, and the "Vector" Main Research Center of Virology and Biotechnology created and tested on the cell culture three genetic structures capable to suppress reproduction of human immunodeficiency virus (HIV-1) in human cells.

At present, the virus is fought against by chemical agents. The drugs subscribed to the patients act predominantly on key HIV-1 enzymes - reverse transcriptase, invertase and protease. There are a lot of antiviral drugs, but they are often ineffective as HIV mutates quickly and acquires drug resistance. And these drugs are, one should note, toxic and very expensive.

Meanwhile, the human organism's cells possess powerful natural mechanism which should regulate the work of genes including viral ones. It is called RNA-interference. In an extremely simplified form, RNA-interference is damage to a certain RNA sequence with participation of a different, "defending" RNA molecule. This system prevents viral infection, unless viruses had learned to cut it off in the course of evolution. Researchers from countries including Russia are developing the artificial RNA-interference system. It is non-injurious to the patient and, due to high specificity of action, does not damage its own RNA in cells infected by the virus.

To fight against HIV, Russian biologists have created three genetic structures. These structures contain short nucleotide sequences that find the most conservative molecules among all RNA molecules, that is, sequences that do not change quickly and are important to the virus. These sequences are then "damaged". The structure also includes the gene of green fluorescent protein, which allows to determine is the gene structure has entered the cell or not.

The researchers embedded the gene structures created by them into cultivated lymphoid cells. Cells which have been penetrated by the fluorescent protein begin to glow with green. Within 24 and 72 hours after introduction of genetic structures, the cells were infected by human immunodeficiency virus (GKV-4046 culture), and several days later the researchers assessed the degree of viral welfare by specific antigen accumulation. It has turned out that the genetic structures significantly suppress viral reproduction.

The extent of damage to viral RNA depends on the viral dose received by the cell itself and on the sequence of the structure per se. The sequence aimed at the reverse transcriptase area of viral genome turned out to be the most efficient, being capable of suppressing the viral production in the cells by 91 to 98 percent within three days.

In the researchers' opinion, similar genetic structures can be used in AIDS gene therapy. At present, the researchers continue the effort on creation of efficiently operating structures, including the ones that are able to overcome high virus mutation.

INFORMNAUKA (INFORMSCIENCE) AGENCY
informnauka.ru/

www.medicalnewstoday.com/medicalnews....

diederique 31 januari 2007 21:49

Press Release: Polydex Pharmaceuticals Halts Phase III trial of Ushercell for HIV Prevention
January 31, 2007

Polydex Pharmaceuticals reports Phase III trial of Ushercell for HIV Prevention Halted

TORONTO, Jan. 31, 2007 -- Polydex Pharmaceuticals Limited reports that CONRAD, a reproductive health research organization, announced today that it has halted a Phase III clinical trial of Ushercell – a cellulose sulfate based topical microbicide gel being tested for HIV prevention in women – because preliminary results at some trial sites indicated that cellulose sulfate could lead to potential increased risk of HIV infection in women who use the compound. The trial was being conducted in South Africa, Benin, Uganda, and India.

Simultaneously, Family Health International (FHI) has halted a second Phase III cellulose sulfate trial in Nigeria. Although the FHI trial did not detect an increased HIV risk associated with cellulose sulfate, the decision was made as a precautionary measure, given the preliminary results in the CONRAD trial. Cellulose sulfate (CS) was one of four microbicides currently in effectiveness trials for prevention of HIV and other sexually transmitted infections.

At this point, it is not clear why use of cellulose sulfate was associated with an increased risk of HIV infection in the CONRAD trial. The Independent Data Monitoring Committee (IDMC), an independent advisory group of experts overseeing the trial, will conduct a detailed review of the data to better understand the findings, and help determine any implications for other microbicide studies.

Dr. Lut Van Damme, principal investigator of the CONRAD trial, stated: “It was our hope that this product would have helped women in protecting themselves from HIV. While the findings are unexpected and disappointing, we will learn scientifically important information from this trial that will inform future HIV prevention research.”

“Ushercell has shown a consistent safety profile up to this point, having undergone 11 rigorous clinical safety and contraceptive trials involving more than 500 participants before entering the HIV prevention trial,” says President and CEO George Usher. Adding “CONRAD will continue to evaluate the findings to help us determine the biological cause of an increased sero-conversion rate detected in the preliminary analysis at some of the trial sites.”

Mr. Usher also said, “We will continue to evaluate Ushercell’s attributes including its potential use as a contraceptive product. Ushercell has demonstrated a high effectiveness rate in the prevention of pregnancy and is still viable for development as a contraceptive. In the meantime, in that Ushercell is still a candidate product in development, the Company’s current income has not been adversely affected by the halting of these trials.”

Recruitment for the CONRAD Phase III study began in July 2005. The study was conducted in areas of the world where HIV risk is greatest, and where infection occurs primarily through heterosexual intercourse. Half of the participating women were given cellulose sulfate, and half a placebo gel, in a double-blinded randomized trial design. All participants received intensive HIV prevention counseling at each monthly visit and all women were given high-quality condoms free of charge. Participants received regular testing and treatment for sexually transmitted infections. Pregnant women were not included in the study.

Participants were admitted into the study only after receiving detailed information about the purpose of the study and the possible health benefits and risks. During this process, the women’s understanding of the study was assessed prior to their signing a consent form. Each trial site is linked to local organizations that provide care for women who become HIV-infected during the trial. As part of the trial preparation, CONRAD set aside funding for women who become HIV-positive during the trial to ensure adequate health care, including ARV treatment as necessary.

“Developing new tools to prevent HIV – particularly for women – is an urgent priority,” said Dr. Henry Gabelnick, Executive Director of CONRAD. “We are committed to learning as much as possible from the trials of cellulose sulfate, and will use that knowledge to continue searching for compounds and collecting evidence to find a successful microbicide. Continued support for microbicide research is critical to our eventual success.”

CONRAD is a cooperating agency of USAID committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV/AIDS and other sexually transmitted diseases. CONRAD is administered through the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA and headquartered in Arlington, VA. www.conrad.org

Polydex Pharmaceuticals Limited, based in Toronto, Ontario, Canada, is engaged in the research, development, manufacture and marketing of biotechnology-based products for the human pharmaceutical market, and also manufactures bulk pharmaceutical intermediates for the worldwide veterinary pharmaceutical industry.

Please visit the Company’s website: www.Polydex.com.

Note: This press release may contain forward-looking statements, within the meaning of the United States Securities Act of 1933, as amended, and the United States Securities Exchange Act of 1934, as amended, regarding Polydex Pharmaceuticals Limited. Actual events or results may differ materially from the Company's expectations, which are subject to a number of known and unknown risks and uncertainties including but not limited to changing market conditions, future actions by the United States Food and Drug Administration or equivalent foreign regulatory authorities as well as results of pending or future clinical trials. Other risk factors discussed in the Company's filings with the United States Securities and Exchange Commission may also affect the actual results achieved by the Company.

Contact:

Contact for CONRAD: Annette Larkin, 202-429-4929, AnnetteLarkin@rationalpr.com

Contact for Polydex Pharmaceuticals Limited: Linda Hughes, 1-877-945-1621, ( Linda@northarm.com )

Contact for FHI: Beth Robinson, 919 405-1461, brobinson@fhi.org www.FHI.org www.fhi.org/

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Umicore	-0,34 -1,96% -0.34 -1.9574
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