Sanofi-Aventis meldet ersten Erfolg aus Studie zu HIV-Impfstoff

24.09.2009 10:38
Sanofi-Aventis meldet ersten Erfolg aus Studie zu HIV-Impfstoff


Der französische Pharmakonzern Sanofi-Aventis <PSAN.PSE> <SNW.ETR> hat in einer sechsjährigen Studie zu einem Impfstoff gegen das HIV-Virus nach eigenen Aussagen einen "wissenschaftlichen Meilenstein" erreicht. Die Phase-III-Studie, an der mehr als 16.000 Erwachsene in Thailand teilgenommen hätten, habe gezeigt, dass der getestete Impfstoff sicher und leicht effektiv sei, teilte die Impfstoffsparte Sanofi Pasteur am Donnerstag in Lyon mit. Auch die Weltgesundheitsorganisation WHO und die UNAIDS veröffentlichten Mitteilungen über den Studienerfolg.

Der Impfstoff habe in den Tests im Vergleich mit einem Scheinmedikament die Rate der HIV-Infektionen um 31,2 Prozent reduziert. Die Ergebnisse seien statistisch signifikant, da es das erste Mal seit der Entdeckung des Virus im Jahr 1983 sei, dass sich ein Impfstoff gegen das AIDS-Virus als leicht effektiv gezeigt habe, hieß es in der Mitteilung weiter. "Das Ergebnis ist ein Durchbruch in der Entwicklung von Aids-Impfstoffen, weil es das erste Mal ist, dass ein HIV-Impfstoff vorbeugend wirkt", sagte der Gesundheitsminister von Thailand, Withaya Kaewparadai. .

Die vollständigen Ergebnisse würden am 20. Oktober auf der Fachtagung "AIDS Vaccine 2009" in Paris vorgestellt./ep/tw

ISIN FR0000120578

AXC0051 2009-09-24/10:38
http://www.finanznachrichten.de/nachrichten-2009-09/15036872-sanofi-aventis-meldet-ersten-erfolg-aus-studie-zu-hiv-impfstoff-016.htm

Sanofi-Aventis:Pleased With Phase III Results For HIV Vaccine

9-24-09 2:35 AM EDT

PARIS -(Dow Jones)- Sanofi Pasteur, the vaccines division of drugmaker Sanofi- Aventis SA (SNY), Thursday commended the results of the collaborative HIV vaccine trial that has been conducted in Thailand over the past six years.
MAIN FACTS:

- The Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection.

- According to the final results released today by the trial sponsor - the U.S. Army Surgeon General - the prime-boost combination of ALVAC HIV and AIDSVAX B/E vaccines lowered the rate of HIV infection by 31.2% compared with placebo.

- The comprehensive results will be presented by the lead clinical investigator on October 20, 2009 at AIDS Vaccine 2009 in Paris.

- Albeit modest, the reduction of risk of HIV infection is statistically significant. This is the first concrete evidence, since the discovery of the virus in 1983, that a vaccine against HIV is eventually feasible," said Michel DeWilde, R&D Senior Vice President for Sanofi Pasteur, the manufacturer of the prime vaccine, ALVAC HIV.

- Christopher A. Viehbacher, Chief Executive Officer of Sanofi-Aventis said: " Sanofi Pasteur will continue its long-standing commitment to HIV vaccine research and development efforts by partnering with academia, governments, non- governmental organizations, and other vaccine companies to progress the science, so that one day we will be able to provide access to HIV vaccines to people who need them."

- By Paris Bureau, Dow Jones Newswires; +331-4017-1740; jethro.mullen@ dowjones.com

(END) Dow Jones Newswires
09-24-090235ET
Copyright (c) 2009 Dow Jones & Company, Inc.

http://news.morningstar.com/newsnet/ViewNews.aspx?article=/D…

Vor einigen Tagen hat auch "Der Aktionär" zu SANOFI geschrieben (muss halt jeder selbst wissen ob dies gut oder schlecht ist):

23.09.2009

Sanofi-Aventis marschiert weiter

Thorsten Küfner
Nach dem Sprung über einen hartnäckigen Widerstand kennt die Aktie des französischen Pharmariesen Sanofi-Aventis nur noch die Richtung nach oben. Für einen Neueinstieg ist es dennoch nicht zu spät.

Nach der Überwindung des hartnäckigen Widerstandes im Bereich von 48 Euro ist die Aktie von Sanofi-Aventis auch über die Marke von 50 Euro gesprungen. Nun erhält der Wert auch Rückenwind von Seiten der Analysten.

Aktie bleibt auf "Selected List"

So haben die Experten von Cheuvreux die Papiere von Sanofi-Aventis auf ihrer "Selected List" belassen. Das Kursziel wurde mit 61,00 Euro bestätigt. Der neuerliche Auftrag zur Produktion von Schweinegrippeimpfstoff für die USA sei nach Meinung der Analysten positiv für den Konzern zu werten.

Auch Kepler zeigte sich zuversichtlich und Kepler empfiehlt die Sanofi-Aventis-Anteile weiterhin zum Kauf. Das Kursziel wurde bei 64,00 Euro belassen. Die weitere Bestellung des Schweinegrippe-Impfstoffes durch die US-Regierung ist nach Ansicht von Analyst Tero Weckroth leicht positiv zu werten. Weil die optimale Dosis des Impfstoffes noch nicht bekannt ist, könnten die mit dem Präparat erzielbaren Renditen allerdings nicht exakt berechnet werden. Dieses einmalige Geschäft sollte aber dennoch einen nachhaltigen Einfluss auf die Bewertung haben.

Aktie bleibt ein Kauf

Wie bereits am Wochenende beschrieben, bleibt die Aktie von Sanofi-Aventis sowohl aus charttechnischen als auch aus fundamentalen Gründen ein Kauf. DER AKTIONÄR rät daher weiterhin zum Kauf der Anteile. Das Kursziel beträgt weiterhin 60 Euro, der Stoppkurs sollte bei 41 Euro platziert werden.

http://www.deraktionaer.de/xist4c/web/Sanofi-Aventis-marschi…

Informationsblatt zu AIDS-Impfstoffen aus dem Jahr 2005, hier ist RV 144 ganz oben aufgelistet:

http://www.iavi.org/Lists/IAVIPublications/attachments/2f7a8…

RV144 Phase III HIV Vaccine Trial


The U.S. Military HIV Research Program (MHRP)


U.S. Army and the Thailand Ministry of Public Health join forces to develop a safe and effective preventive HIV vaccine

Introduction

The Thai Phase III HIV vaccine clinical trial, also known as RV 144, tested the “prime-boost” combination of two vaccines: ALVAC-HIV® vaccine (the prime), and AIDSVAX® B/E vaccine (the boost). The vaccine combination was based on HIV strains that commonly circulate in Thailand.

RV 144 was designed to test the vaccine strategy’s ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood (viral load) of those who became infected after they enrolled in the study.

The study was made possible by an international collaboration involving numerous partners from the Thai and U.S. governments, private companies, non-profit organizations and more than 16,000 volunteers.

Study Background

With the emergence of an explosive HIV epidemic in Thailand in the early 1990s, Army researchers helped to characterize the heterosexual epidemic, isolated Thai viruses, and made these sequences available to companies developing HIV vaccines. Army researchers have had a long-standing relationship with the Royal Thai Army, Thai Ministry of Public Health and other Thai vaccine experts, and together they developed a plan to test this candidate vaccine in Thailand.

Strong Safety Record

An international Data and Safety Monitoring Board met eight times since trial initiation and did not identify any safety concerns.

The study vaccines did not cause HIV infection because they are not made from and do not contain the entire virus, either live or killed.

Study Volunteers

* 16,402 non-infected volunteers (18-30 years old) at average risk of HIV infection; half received the prime-boost combination of vaccines/half received a placebo.
* Vaccinations ended in July 2006, and volunteers received an HIV test every six-months for three- years.
* Study volunteers received counseling on how to prevent becoming infected with HIV at the beginning of the study and every six months after the start of the trial, for a total of three and a half years.
* Before agreeing to participate, all volunteers were informed of and consented to the potential risks associated with receiving the experimental vaccine combination.
* Volunteers who acquired HIV infection during the trial were given free access to HIV care and treatment, and were offered follow-up in a separate study.

Global Significance

The HIV pandemic is an unprecedented global crisis. An HIV vaccine continues to be the best hope for ending the HIV pandemic. The U.S. Army is committed to developing a globally effective HIV vaccine to protect U.S. and allied troops from infection and to support the U.S. National Security Strategy by reducing the global impact of the disease.

HIV vaccine research—like all scientific research—is an iterative process. The knowledge gained through this clinical trial will be used to design future studies.
Study Sponsor

The study is sponsored by the U.S. Army and is conducted by the Thailand Ministry of Public Health.

The U.S. Military HIV Research Program provides overall project leadership, and the U.S. Army Medical Component – Armed Forces Research Institute of Medical Sciences (AFRIMS) helps execute the trial in Thailand on behalf of the Sponsor.

AFRIMS is a Special Foreign Activity of Walter Reed Army Institute of Research (WRAIR) hosted by the Royal Thai Army and staffed by American and Thai personnel. For almost 50 years, AFRIMS has been America's premier Asian site to study infectious diseases of military importance.

This study was supported by a cooperative agreement with the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

STUDY

* RV144: A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV® (vCP1521) Priming with VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-uninfected Thai Adults

SPONSOR

* U.S. Army Surgeon General

FUNDING

* Division of AIDS, National Institutes of Allergy and Infectious Diseases, NIH
* U.S. Army Medical Research and Materiel Command

LOCATION

* Rayong and Chon Buri Provinces, Thailand
* 47 health centers (screening and tracking)
* 8 clinical sites

VACCINE MANUFACTURERS

* Global Solutions for Infectious Diseases-AIDSVAX B/E
* sanofi-pasteur-ALVAC-HIV vCP1521

*Global Solutions for Infectious Diseases (GSID) holds the intellectual property rights to AIDSVAX B/E originally developed and previously owned by VaxGen.

STUDY EXECUTION

* Department of Disease Control, Thai Ministry of Public Health (MOPH)
* Vaccine Trials Centre, Faculty of Tropical Medicine, Mahidol University
* Data Management Unit, Faculty of Tropical Medicine, Mahidol University
* Chon Buri and Rayong Provincial Chief Medical Offices, MOPH
* Armed Forces Research Institute of Medical Sciences; Thai Component and U.S. Component (USAMC-AFRIMS)
* Division of Retrovirology, WRAIR, MHRP
* U.S. Army Medical Materiel Development Activity, U.S. Army Medical Research and Materiel Command

It is important to note that a vaccine must be seen as part of a comprehensive approach to prevention of HIV infection. The true public health benefits of any vaccine, and particularly of an experimental vaccine that has not yet been licensed, can only be realized if vaccine recipients continue to control HIV risk-taking behavior.

http://www.hivresearch.org/phase3/factsheet.html

For First Time, AIDS Vaccine Shows Some Success in Trials


Article Tools Sponsored By
By DONALD G. McNEIL Jr.
Published: September 24, 2009

A new AIDS vaccine tested on more than 16,000 volunteers in Thailand has protected a significant minority against infection, the first time any vaccine against the disease has even partly succeeded in a clinical trial.

Scientists said they were delighted but puzzled by the result. The vaccine — a combination of two genetically engineered vaccines, neither of which had worked before in humans — protected too few people to be declared an unqualified success. And the researchers do not know why it worked.

“I don’t want to use a word like ‘breakthrough,’ but I don’t think there’s any doubt that this is a very important result,” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, which is one of the trial’s backers.

“For more than 20 years now, vaccine trials have essentially been failures,” he went on. “Now it’s like we were groping down an unlit path, and a door has been opened. We can start asking some very important questions.”

Results of the trial of the vaccine, known as RV 144, were released at 2 a.m. Eastern time Thursday in Thailand by the partners that ran the trial, by far the largest of an AIDS vaccine: the United States Army, the Thai Ministry of Public Health, Dr. Fauci’s institute, and the patent-holders in the two parts of the vaccine, Sanofi-Pasteur and Global Solutions for Infectious Diseases.

Col. Jerome H. Kim, a physician who is manager of the army’s H.I.V. vaccine program, said half the 16,402 volunteers were given six doses of two vaccines in 2006 and half were given placebos. They then got regular tests for the AIDS virus for three years. Of those who got placebos, 74 became infected, while only 51 of those who got the vaccines did.

Although the difference was small, Dr. Kim said it was statistically significant and meant the vaccine was 31.2 percent effective.

Dr. Fauci said that scientists would seldom consider licensing a vaccine less than 70 or 80 percent effective, but he added, “If you have a product that’s even a little bit protective, you want to look at the blood samples and figure out what particular response was effective and direct research from there.”

The most confusing aspect of the trial, Dr. Kim said, was that everyone who did become infected developed roughly the same amount of virus in their blood whether they got the vaccine or a placebo.

Normally, any vaccine that gives only partial protection — a mismatched flu shot, for example — at least lowers the viral load.

That suggests that RV 144 does not produce neutralizing antibodies, as most vaccines do, Dr. Fauci said. Antibodies are long Y-shaped proteins formed by the body that clump onto invading viruses, blocking the surface spikes with which they attach to cells and flagging them for destruction.

Instead, he theorized, it might produce “binding antibodies,” which latch onto and empower effector cells, a type of white blood cell attacking the virus.

Whatever the vaccine does, he said, it does not seem to mimic the defenses of the rare individuals known to AIDS doctors as “long-term nonprogressors,” who do not get sick even though they are infected. They have low viral loads because they block reproduction in some way that is still mysterious.

“If we knew what immune response did it, we’d be able to be a lot more efficient in targeting it,” Dr. Kim said.

Also, the RV 144 tested in Thailand was designed to combat the most common strain of the virus circulating in Southeast Asia. Different strains circulate in Africa, the United States and elsewhere, and it is not clear that the vaccine would have similar results, even in modified form.

The thousands of Thais chosen were a cross-section of the Thai young adult population, not just high-risk groups like drug injectors or sex workers, Dr. Kim said.

One of the substances that were combined to make RV 144 is Alvac-HIV, from Sanofi-Pasteur, a canarypox virus with three AIDS virus genes grafted onto it. Variations of Alvac were tested in France, Thailand, Uganda and the United States; it was found safe but generated little immune response.

The other, Aidsvax, was originally made by Genentech and is an engineered version of a protein found on the surface of the AIDS virus; it is grown in a broth of hamster ovary cells.

It was tested in Thai drug users in 2003 and also in gay men in North America and Europe; it did not protect them against infection, and Genentech spun off the rights to develop the vaccine.

In 2007, two trials of a Merck vaccine in about 4,000 people were stopped early; it not only failed to work but for some men seemed to increase the risk of infection.

Combining Alvac and Aidsvax was a hunch by scientists: If one was designed to create antibodies and the other to alert white blood cells, might they work together even if neither worked alone?

Mitchell Warren, executive director of AVAC, the AIDS Vaccine Advocacy Coalition, which pushes for vaccines and other forms of prevention, was enthusiastic about the trial data.

“Wow,” he said. “This is a hugely exciting and, frankly, unexpected result. It changes our thinking in ways we hadn’t anticipated.”

“We often talk about whether a vaccine is even possible,” he added. “This is not the vaccine that ends the epidemic and says, ‘O.K., let’s move on to something else.’ But it’s a fabulous new step that takes us in a new direction.”

Mr. Warren said the finding showed the need for large human trials, expensive as they are. Studies in mice and monkeys have not been good at predicting what would work in people, and small human trials in which researchers test results by looking for antibodies in blood have limited value.

Dr. Fauci agreed.

“This is not the endgame,” he said. “This is the beginning.”

http://www.nytimes.com/2009/09/25/health/research/25aids.htm…

Sanofi-Aventis:Pleased With Phase III Results For HIV Vaccine


PARIS -(Dow Jones)- Sanofi Pasteur, the vaccines division of drugmaker Sanofi- Aventis SA (SNY), Thursday commended the results of the collaborative HIV vaccine trial that has been conducted in Thailand over the past six years.

MAIN FACTS:

- The Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection.

- According to the final results released today by the trial sponsor - the U.S. Army Surgeon General - the prime-boost combination of ALVAC HIV and AIDSVAX B/E vaccines lowered the rate of HIV infection by 31.2% compared with placebo.

- The comprehensive results will be presented by the lead clinical investigator on October 20, 2009 at AIDS Vaccine 2009 in Paris.

- Albeit modest, the reduction of risk of HIV infection is statistically significant. This is the first concrete evidence, since the discovery of the virus in 1983, that a vaccine against HIV is eventually feasible," said Michel DeWilde, R&D Senior Vice President for Sanofi Pasteur, the manufacturer of the prime vaccine, ALVAC HIV.

- Christopher A. Viehbacher, Chief Executive Officer of Sanofi-Aventis said: " Sanofi Pasteur will continue its long-standing commitment to HIV vaccine research and development efforts by partnering with academia, governments, non- governmental organizations, and other vaccine companies to progress the science, so that one day we will be able to provide access to HIV vaccines to people who need them."

- By Paris Bureau, Dow Jones Newswires; +331-4017-1740; jethro.mullen@ dowjones.com

(END) Dow Jones Newswires
09-24-090235ET
Copyright (c) 2009 Dow Jones & Company, Inc.

http://www.nasdaq.com/aspx/stock-market-news-story.aspx?stor…

Antwort auf Beitrag Nr.: 38.047.592 von Poppholz am 24.09.09 13:02:51upps, doppelt.

Ist aus unterschiedlichen Quellen, sorry.