Sanofi-aventis y CureDM firman un acuerdo

París (Francia) – 8 de abril de 2010 – Sanofi-aventis (EURONEXT: SAN y NYSE: SNY) y CureDM Group Holdings, LLC,

anuncian la firma de un acuerdo de licencia mundial sobre un nuevo péptido humano, Pancreate™, que podría restablecer la capacidad de producir insulina y otras hormonas pancreáticas en pacientes diabéticos de tipo 1 y 2.
Pancreate™ es una secuencia peptidica bioactiva procedente de una proteína humana natural que, en una serie de ensayos preclínicos, ha demostrado su capacidad de estimular el crecimiento de nuevos islotes pancreáticos capaces de producir insulina. De esta forma, hace posible el restablecimiento de la función metabólica normal y el control de la glucosa sanguínea. El inicio de los ensayos de Fase I tendrá lugar a lo largo de este año.
En virtud del acuerdo, sanofi-aventis recibirá una licencia exclusiva mundial para desarrollar, fabricar y comercializar Pancreate™ y sus compuestos asociados. CureDM recibirá un pago inicial y una serie de pagos escalonados en concepto de desarrollo del producto, registro y comercialización. En total, estos pagos podrían ascender a 335 millones de dólares americanos. Además, CureDM tendrá derecho a una serie de royalties graduales, en función de las ventas mundiales del producto.
“Sanofi-aventis está especialmente contenta por el hecho de incluir en el portafolio de su División Diabetes esta importante innovación, que posee el potencial de estimular la formación de nuevos islotes pancreáticos totalmente funcionales, contribuyendo así al restablecimiento de la función pancreática normal”, comentó Marc Cluzel, Vicepresidente Ejecutivo de I+D de sanofi-aventis. “Una vez desarrollado, Pancreate™ podría convertirse en el primer tratamiento de medicina regeneradora para la diabetes tipo 1 y tipo 2 y permitiría ofrecer una respuesta a los considerables retos que supone la epidemia de diabetes, tanto para los pacientes como para los sistemas sanitarios”.
Este nuevo acuerdo de colaboración es otro ejemplo del compromiso estratégico de sanofi-aventis destinado a desarrollar su liderazgo en el área de la diabetes, a través de las nuevas tecnologías. Asimismo, confirma su objetivo de convertirse en líder mundial en el área de la diabetes.

A propósito de Pancreate™
Pancreate™ (acetato de proisletide), primero de su clase farmacoterapéutica, es una secuencia peptidica humana (HIP-2B) de una proteína humana natural, que estimula la formación de nuevos islotes pancreáticos capaces de producir insulina funcional, a partir de células madre pancreáticas. La diabetes, tanto de tipo 1 como de tipo 2, se caracteriza por la insuficiencia funcional de los islotes encargados de fabricar la insulina necesaria para el organismo. Los islotes son complejas estructuras que contienen las células beta (productoras de insulina) y otros cuatro tipos de células, todas ellas importantes en el mantenimiento de los niveles de glucosa. Estos islotes garantizan el control metabólico de la liberación de insulina y hacen que el páncreas pueda mantener un nivel constante de glucosa en la sangre. El restablecimiento de islotes completos y funcionales es fundamental para corregir las fluctuaciones de glucosa sanguínea características de la diabetes. Pancreate™ es un enfoque totalmente innovador en el tratamiento de esta enfermedad.

CureDM and Sanofi-Aventis sign agreement over Pancreate

CureDM LLC, has signed an agreement with Sanofi-Aventis for the exclusive worldwide license of Pancreate (proisletide acetate).

The first-in-class human peptide therapeutic is a novel islet neogenesis agent indicated for the treatment of type one and type two diabetes.

Scientists from privately held biopharmaceutical company CureDM discovered Pancreate and the firm holds several key patents for the treatment.

Under the new agreement, Sanofi-Aventis holds the exclusive worldwide rights to manufacture, develop and market Pancreate for the treatment of diabetes in human and animal patients.

Dr Joseph Reiser, president and chief executive officer of CureDM, said the company was “extremely pleased” about the agreement with Sanofi-Aventis.

“We believe that Sanofi-Aventis is the ideal partner to bring our novel therapeutic approach to patients, given Sanofi’s leading and far-reaching strategic commitment in the field of diabetes,” he added.

Last month, a new blood glucose meter called Contour USB was launched by Bayer Diabetes Care in Ireland and the UK.

Sanofi-aventis invests €150 million in France and continues its Change towards Biotechnologies

Paris, France – March 31, 2010 – Sanofi-aventis presented today to its social partners

in France the project for investing and adapting its chemical and biotechnology manufacturing facilities in France over the next four years. The goal of the project includes the change of the sanofi-aventis chemical industrial activities in France towards biotechnology and vaccine production by 2014. The project also prepares the facilities for a decline in production that will follow patent expirations of several major drugs derived by synthetic chemistry.

“The change of our industrial network towards more biotechnologies corresponds to the evolution of innovation in the pharmaceutical world, more and more balanced between vaccines and compounds arising from biotechnologies, and active ingredients derived from synthetic chemistry”, declared Philippe Luscan, Senior Vice President, Industrial Affairs, sanofi-aventis. “This project is fully in line with the Group’s strategy and will allow sanofi-aventis to maintain its competitive advantage, to generate sustainable growth and to keep a steady number of industry jobs in France, over the next four years”.

Sanofi-aventis will invest €150 million in its industrial plants, including € 90 million for the creation of a new innovative biosynthetic process in the industrial plants in Saint-Aubin-Lés-Elbeuf, in Seine-Maritime, France, and Vertolaye, in Puy de Dôme, France, in order to improve our corticosteroid production competitiveness at a global level. The new activities will result in local job creation.

Some new activities from Sanofi Pasteur would be housed in the new facility in Neuville-sur-Saône, Rhône, France, where the new vaccine against the dengue fever is already planned to be produced. This plant will become the Group’s third largest European center fully dedicated to vaccines by 2014.

Sanofi-aventis’ new plan also include a gradual phase-out of the facilities in Romainville, in Seine-Saint Denis, France, by the end of 2013, accompanied by a job stimulus plan to be implemented in the area.

The project will also includes measures to assist employees’ geographic mobility, especially in the Paris and Lyon area labor basins, and to facilitate career mobility by means of biotechnology training programs for 700 employees, to be implemented in partnership with French Universities. No other change in the industrial network is planned within the same period.

Since 2008, sanofi-aventis has devoted a total of €700 million in investments to evolve its chemical production facilities in France to biotechnology capabilities – including the €350 million investment in Neuville-sur-Saône, and €200 million in Vitry-sur-Seine.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

BioInvent and Human Genome Sciences Announce Collaboration to Co-develop and Commercialize Therapeutic Antibodies

Lund, Sweden and Rockville, Maryland – 11 March 2010 – BioInvent International AB (OMXS: BINV) and Human Genome Sciences, Inc. (NASDAQ: HGSI) today announced that they have entered into a collaboration to discover, develop and commercialize therapeutic monoclonal antibodies which specifically target antigens discovered by HGS.
Under the terms of the agreement, BioInvent will apply its state-of-the art antibody discovery technology to generate and develop monoclonal antibody candidates. The collaboration will initially focus on the development of antibodies in the field of inflammation. BioInvent and HGS will each have the right to participate in development and global commercialization of each antibody candidate, and will share research, development, manufacturing and commercialization costs as well as future revenues. Specific terms were not disclosed.
Svein Mathisen, Chief Executive Officer of BioInvent, said “Access to commercially attractive targets to which we can apply our antibody discovery engine is an important part of BioInvent’s strategy. We believe this collaborative agreement is a strong and valuable way of building our pipeline of innovative drugs as BioInvent and HGS’s research strengths are both complementary and synergistic. We are looking forward to working closely with HGS in what we believe will be a long-term, productive collaboration.”
“We continue to make excellent progress in advancing our late-stage products toward commercialization, and at the same time we remain committed to building and advancing our research pipeline to ensure sustainable growth well into the future,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We look forward to collaborating with BioInvent to apply their proprietary technology to the development of targeted new therapies based on HGS discoveries.”
– END –
Notes to Editors:
About the BioInvent Proprietary Antibody Discovery Platform
BioInvent’s proprietary antibody discovery platform, n-CoDeR®, contains over 20 billion (2 x1010) human antibody genes, a far greater number than those naturally available in the human immune system. This provides a greater likelihood of finding antibodies with both high affinity and specificity against a particular target. BioInvent has a broad and innovative portfolio of therapeutic antibodies, with four products currently in clinical development in the fields of thrombosis, atherosclerosis and cancer.
About the HGS New Targets Initiative
HGS has a rich heritage of scientific discovery that has produced a large intellectual property estate and a library of thousands of therapeutic and diagnostic targets. HGS has conducted a careful review and selected a number of targets for further research and potential development. HGS plans to develop the selected targets through its own internal research, as well as through research collaborations, including the agreement with BioInvent announced today.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based
pharmaceutical company that focuses on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed
various strategic alliances around these product candidates and is developing them in collaboration with
partners including Genentech, Roche and ThromboGenics.
These projects are based around a competitive and in substance patented antibody development platform.
The scope and strength of this platform is also utilised by partners, such as ALK-Abelló, Bayer HealthCare, Daiichi Sankyo, ImmunoGen, Mitsubishi Tanabe, OrbusNeich, UCB and XOMA.
More information is available at www.bioinvent.com.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat lupus, hepatitis C, inhalation anthrax and cancer.
The Company’s primary focus is rapid progress toward the commercialization of its two lead drugs, BENLYSTA™ (belimumab) for systemic lupus and ZALBIN™ (albinterferon alfa-2b) for hepatitis C. Phase 3 development has been completed successfully for both BENLYSTA and ZALBIN. The submission of marketing applications for BENLYSTA is planned in the U.S., Europe and other regions in the second quarter of 2010. A BLA has been submitted for ZALBIN to the FDA in the United States, and an MAA has been submitted under the brand name JOULFERON® to the EMEA in Europe.
In April 2009, HGS completed the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalation anthrax. In July 2009, HGS secured a new purchase order for 45,000 doses, and the Company delivered the first 5,600 doses to the Stockpile under the new order in November 2009.
HGS also has several drugs in earlier stages of development for treatment of cancer, led by the TRAIL receptor antibody mapatumumab and a small-molecule antagonist of inhibitor-of-apoptosis proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, in Phase 3 development in patients with coronary heart disease, and Syncria® (albiglutide), in Phase 3 development in patients with type 2 diabetes.
For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.com or by calling HGS at (877) 822-8472.
HGS, Human Genome Sciences, BENLYSTA, and ZALBIN are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.

Streptococcus vaccine trials a success for Intercell

Vienna – Austria-based Intercell AG yesterday announced that its first-in-man trial of the subunit vaccine IV47, designed to prevent infections from the majority of so Streptococcus pneumoniae serotypes, of which there are over 90. Two dose levels of the recombinant protein vaccine, consisting of two proprietary conserved Streptococcus pneumonia antigens and the PsaA antigen, were well tolerated by 32 healthy adults when administerd with or without adjuvans (aluminium hydroxide). According to Intercell, the vaccine was immunogenic, and antigen dose-dependent induction of antibodies was confirmed for all three proteins of the vaccine. The study was supported by PATH, an international global health non-profit organization is aiding the development of this vaccine. The partnership of Intercell and PATH (more…) aligns the goals of each organisation: Intercell’s pursuit of a vaccine for the elderly in the US and Europe and PATH’s goal of an affordable vaccine for infants and children (more...) in the developing world. Current vaccines against S. pneumoniae do not target the serotypes that are commonly found in Asian or African children. Pneumococcal disease kills about 1.6 million people each year, with more than half of those deaths in children less than five years old in developing countries.

GRAFFINITY ENTERS INTO DRUG DISCOVERY RESEARCH COLLABORATION WITH GENENTECH

HEIDELBERG, Germany — October 15, 2009 — Graffinity Pharmaceuticals GmbH announced today that it has entered into a drug discovery research collaboration with Genentech, Inc, a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY). With this collaboration Genentech will gain access to Graffinity’s proprietary, fragment-based drug discovery technology. Under the terms of the agreement, Graffinity will receive technology access fees and optional payments for follow-up chemistry for the generation of novel, small molecule hits against a number of drug targets. Financial details of the transaction were not disclosed. Mathias Woker, Chief Business Officer of Graffinity, stated, ”We are very pleased that Genentech has decided to partner with us in fragment-based drug discovery. This marks our second collaboration with Genentech, and we think that this new agreement demonstrates how attractive Graffinity’s very large fragment library and rapid surface plasmon resonance (SPR) screening technology are.” Kristina Schmidt, CEO of Graffinity, remarked, ”Our label-free, biophysics-based screening technology has shown to be an important element for companies which choose to work with us. With the help of this technology we enable partners, such as Genentech, to explore drug targets that would remain white spaces on the map of drug discovery, if researchers were limited to other conventional high-throughput screening techniques.” About Graffinity Pharmaceuticals GmbH Heidelberg, Germany based Graffinity Pharmaceuticals is a leader in the field of small molecule fragment based drug discovery. The company pursues high-profile drug discovery collaborations with leading pharmaceutical and biotechnology companies worldwide. Graffinity employs a flexible business model which allows it to tailor programs to the specific needs of each partner and offers numerous benefits to its customers on a straightforward feefor- service basis. Graffinity’s fragment screening platform combines chemical microarrays GRAFFINITY ENTERS INTO DRUG DISCOVERY RESEARCH COLLABORATION WITH GENENTECH Page 2 with a proprietary method for the standardized, label-free detection of compound-protein interactions via SPR imaging. The company’s rapid and scalable drug discovery technology explores a rich chemical universe to identify drug fragments which address challenging drug targets. With its 110,000-compound library that contains 23,000 true fragments, Graffinity possesses one of the most diverse fragment libraries. During the past three years Graffinity has established collaborations with pharmaceutical and biotechnology partners including Amgen, AstraZeneca, Boehringer-Ingelheim, Elan, Pfizer and Rigel. Graffinity’s unique fragment based discovery platform was invented in 1998, and has been in routine industrial use since 2002 in screening more than 85 drug targets. For more information, please visit www.graffinity.com.

Telstar Group Of Companies Have Launched The New Business Line For Pharma And Biotech Industries

September 22, 2009

Telstar Group of companies launches to market the new business line, offering integrated solutions for Ultra-Pure water and steam systems to Pharma and Biotech industries; Telstar Water Systems (TWS) offers complete generation and distribution systems for ultra-pure water and steam designed and manufactured in accordance with the latest pharmacopeias.

This new business line is the result of the analysis of synergies made within the group to merge all advantageous capabilities of Tpro in project Management and Telstar Life & Sciences in high-tech equipment design and manufacturing; mayor in Pharma and Biotech together with R+D laboratories, and in general all industries requiring state of the art, compliant equipment and installations for their critical systems.

Integrating Project Engineering together with equipment Manufacturing and installation, gives Telstar Water Systems a perfect standpoint for considering all needs on the complexity of ultra-pure water and steam systems; understood at TWS as a whole, rather than a provision of a combination of equipment. TWS sees ultra-pure water and steam as systems perfectly integrated from incoming water to user point; offering a wide range of products and solutions to fit with the particular needs, each system have.

Inheriting a significant international experience, guaranteed by more than 20 years providing equipment, installations and moreover complete production plants on the most challenging and demanding international markets, gives Telstar Water Systems the capacity not only for executing projects on European market but capabilities to provide complete and integrated systems world wide, with the highest standards offering full guarantee of service & compliance.

All over these 45 years of experience developing equipment and turn-key projects for Bio-Pharmaceutical market, specially on critical processes, Telstar Group of Companies stands out as one of the few companies around the world able to provide guaranteed integrated solutions, for such a demanding sectors.

SOURCE: Telstar Group

EUROPA DA LUZ VERDE A YONDELIS® PARA EL TRATAMIENTO DEL CÁNCER DE OVARIO RECURRENTE PLATINO-SENSIBLE

Es la segunda recomendación de aprobación por parte de la EMEA que recibe Yondelis®, que ya se comercializa para el tratamiento del sarcoma de tejidos blandos en adultos

Madrid, 25 de septiembre de 2009: PharmaMar, compañía biofarmacéutica filial de Zeltia, S.A., ha sido informada por la Agencia Europea de Medicamentos (EMEA) que su Comité Evaluador de Productos Medicinales de Uso Humano (CHMP) ha emitido por consenso una Opinión Positiva recomendando la concesión de la autorización de comercialización de Yondelis® (trabectedina) administrado con CAELYX® (doxorubicina liposomal pegilada) para el tratamiento del cáncer de ovario recurrente platino-sensible en la Unión Europea.

Yondelis® será ahora propuesto para aprobación final por la Comisión Europea en la indicación señalada y la autorización de comercialización podría ser otorgada próximamente.

El Comité Evaluador de Productos Medicinales de Uso Humano (CHMP) de la EMEA revisó los datos del ensayo multicéntrico, randomizado y de fase III con 672 pacientes que comparó trabectedina en combinación con DOXIL®/CAELYX® y DOXIL®/CAELYX® en monoterapia, en pacientes con cáncer de ovario recurrente tras la terapia estándar con platino.

PharmaMar presentó el dossier de registro en diciembre de 2008. La recomendación del comité de expertos se basa en la seguridad y eficacia del tratamiento en pacientes con cáncer de ovario recurrente tras la terapia estándar con platino. La Comisión Europea deberá en los próximos meses ratificar la recomendación positiva de la EMEA para que se conceda la autorización de comercialización del fármaco en toda la Unión Europea.

Si se cumplen los plazos previstos, se espera que muchas pacientes europeas tengan acceso a Yondelis® antes de que termine el año, en cuyo caso trabectedina combinado con DOXIL®/CAELYX® sería la única terapia de combinación libre de platinos y taxanos para los pacientes que sufren una recaída tras la quimioterapia inicial.

“Estamos muy satisfechos con la recomendación de la EMEA, que apoya otra vez el trabajo realizado por PharmaMar y que proporciona una nueva opción de tratamiento para una enfermedad con escasas opciones de tratamiento como es el cáncer de ovario recurrente”, ha dicho Jose María Fernández Sousa-Faro, Presidente de PharmaMar.

PharmaMar sigue con el desarrollo de su cartera de productos, una de las de mayor potencial en Oncología, lo que la convierte en un actor clave en el panorama de la industria farmacéutica europea.

Sobre Yondelis®
Yondelis® es un nuevo agente antitumoral derivado originalmente del tunicado caribeño Ecteinascidia turbinata. El compuesto se produce actualmente de manera sintética. Yondelis® se une al surco menor del ADN, interfiriendo con la división celular y los procesos de transcripción genética y la maquinaria de reparación del ADN.
Bajo acuerdo de licencia con PharmaMar SA, Centocor Ortho Biotech Products, L.P. posee los derechos de comercialización mundiales para trabectedin excepto en Europa, donde el producto es comercializado como Yondelis® por PharmaMar SA., y Japón, donde PharmaMar SA y Taiho Pharmaceutical CO., LTD. tienen un acuerdo de licencia para desarrollar y comercializar Yondelis®.

Sobre cáncer de ovario
El cáncer epitelial de ovario representa el 4% de todos los cánceres que afectan a las mujeres y es la quinta causa de muerte por cáncer en la población femenina (según American Cancer Society [ACS], Cancer Reference Information, 2005). Se estima que en 2006 se diagnosticaron 205.000 casos nuevos de cáncer de ovario en el mundo y que más de 125.000 mujeres morirán a causa de esta enfermedad (Globocan, 2005). Según la Organización Mundial de la Salud, las tasas más altas se producen en Estados Unidos, Canadá, Escandinavia y Europa del Este.

La tasa de mortalidad por esta enfermedad no ha cambiado sustancialmente en los últimos 50 años.
Es la primerea causa de muerte por cáncer ginecológico. La edad media de las mujeres con cáncer de ovario es de 60 años, aunque puede afectar a mujeres más jóvenes, sobretodo en casos con antecedentes familiares de la enfermedad. Un 70% de las mujeres con cáncer de ovario son diagnosticadas tarde, cuando la enfermedad está ya en etapas avanzadas (estadios III y IV). Sólo el 15%-20% de las pacientes con enfermedad avanzada sobreviven cinco o más años.

Sobre Sarcoma de Tejidos Blandos
Los STB son un grupo heterogéneo de más de 50 tipos de tumores que aparecen en el tejido adiposo, músculo, tejido nervioso, tendones y sangre y vasos linfáticos. Casi la mitad de estos tumores afectan a las extremidades. Los sarcomas de tejidos blandos (STB) tienen una incidencia de alrededor de 3/100,000 nuevos casos por año, lo que representa el 2% de la mortalidad global por cáncer. La incidencia más alta se sitúa en torno a pacientes de 50 años de edad. La tasa de supervivencia de los pacientes con STB a los cinco años es de alrededor del 90% cuando se detecta temprano (fase I), es decir, cuando el tumor es pequeño y sin metástasis. Sin embargo, la tasa de supervivencia a los cinco años en pacientes con enfermedad metastásica es del 10-20%. Se estima que la esperanza de vida en pacientes con metástasis es 8-12 meses después de haber recibido la primera línea de terapia.

Sobre PharmaMar
PharmaMar es una compañía biofarmacéutica del Grupo Zeltia y líder mundial en el descubrimiento y el desarrollo de nuevos medicamentos de origen marino contra el cáncer. Yondelis® es el primer fármaco anticancerígeno español, que se comercializa actualmente en varios países de la Unión Europea para el tratamiento del sarcoma de tejidos blandos. PharmaMar cuenta con cuatro nuevos compuestos en desarrollo clínico: Yondelis® ha recibido autorización para la comercialización de la Comisión Europea para el sarcoma de tejidos blandos. Yondelis® también está en la fase III para el cáncer de ovario y de la fase II de próstata, mama y cánceres pediátricos. Aplidin®, Kahalalide F, Zalypsis® y PM01183 en ensayos clínicos. PharmaMar también tiene una rica cartera de preclínica de candidatos, y un fuerte programa de investigación y desarrollo.

Nota importante
PharmaMar, con sede en Madrid, España, es una filial de Zeltia, S.A. (Bolsa española, ZEL), compañía cuyas acciones se negocian en la Bolsa española desde 1963 y el mercado continuo español desde 1998. Este documento es un comunicado de prensa, no un folleto. Este documento no constituye ni forma parte de ninguna oferta o invitación a la venta o la solicitud de cualquier cuestión de la compra, la oferta o la suscripción de acciones de la Pharma Mar o Zeltia. Asimismo, este documento, ni su distribución es o puede ser parte de la base para cualquier decisión de inversión o contrato y no constituye ningún tipo de recomendación en relación con las acciones de Pharma Mar o Zeltia.

A world first: Vaccine helps prevent HIV infection

BANGKOK – For the first time, an experimental vaccine has prevented infection with the AIDS virus, a watershed event in the deadly epidemic and a surprising result. Recent failures led many scientists to think such a vaccine might never be possible.

The vaccine cut the risk of becoming infected with HIV by more than 31 percent in the world’s largest AIDS vaccine trial of more than 16,000 volunteers in Thailand, researchers announced Thursday in Bangkok.

Even though the benefit is modest, “it’s the first evidence that we could have a safe and effective preventive vaccine,” Col. Jerome Kim said in a telephone interview. He helped lead the study for the U.S. Army, which sponsored it with the National Institute of Allergy and Infectious Diseases.

The institute’s director, Dr. Anthony Fauci, warned that this is “not the end of the road,” but said he was surprised and very pleased by the outcome.

“It gives me cautious optimism about the possibility of improving this result” and developing a more effective AIDS vaccine, Fauci said in a telephone interview. “This is something that we can do.”

Even a marginally helpful vaccine could have a big impact. Every day, 7,500 people worldwide are newly infected with HIV; 2 million died of AIDS in 2007, the U.N. agency UNAIDS estimates.

“Today marks an historic milestone,” said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, an international group that has worked toward develping a vaccine.

“It will take time and resources to fully analyze and understand the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field,” he said in a statement.

The Thailand Ministry of Public Health conducted the study, which used strains of HIV common in Thailand. Whether such a vaccine would work against other strains in the U.S., Africa or elsewhere in the world is unknown, scientists stressed.

The study actually tested a two-vaccine combo in a “prime-boost” approach, where the first one primes the immune system to attack HIV and the second one strengthens the response.

They are ALVAC, from Sanofi Pasteur, the vaccine division of French drugmaker Sanofi-Aventis; and AIDSVAX, originally developed by VaxGen Inc. and now held by Global Solutions for Infectious Diseases, a nonprofit founded by some former VaxGen employees.

ALVAC uses canarypox, a bird virus altered so it can’t cause human disease, to ferry synthetic versions of three HIV genes into the body. AIDSVAX contains a genetically engineered version of a protein on HIV’s surface. The vaccines are not made from whole virus — dead or alive — and cannot cause HIV.

Neither vaccine in the study prevented HIV infection when tested individually in earlier trials, and dozens of scientists had called the new one futile when it began in 2003.

“I really didn’t have high hopes at all that we would see a positive result,” Fauci confessed.

The results proved the skeptics wrong.

“The combination is stronger than each of the individual members,” said the Army’s Kim.

The study tested the combo in HIV-negative Thai men and women ages 18 to 30 at average risk of becoming infected. Half received four “priming” doses of ALVAC and two “boost” doses of AIDSVAX over six months. The others received dummy shots. No one knew who got what until the study ended.

All were given condoms, counseling and treatment for any sexually transmitted infections, and were tested every six months for HIV. Any who became infected were given free treatment with antiviral medicines.

Participants were followed for three years after vaccination ended.

Results: New infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 percent lower risk of infection for the vaccine group.

The vaccine had no effect on levels of HIV in the blood of those who did become infected. That had been another goal of the study — seeing whether the vaccine could limit damage to the immune system and help keep infected people from developing full-blown AIDS.

That result is “one of the most important and intriguing findings of this trial,” Fauci said. It suggests that the signs scientists have been using to gauge whether a vaccine was actually giving protection may not be valid.

“It is conceivable that we haven’t even identified yet” what really shows immunity, which is both “important and humbling” after decades of vaccine research, Fauci said.

Details of the $105 million study will be given at a vaccine conference in Paris in October.

This is the third big vaccine trial since 1983, when HIV was identified as the cause of AIDS. In 2007, Merck & Co. stopped a study of its experimental vaccine after seeing it did not prevent HIV infection. Later analysis suggested the vaccine might even raise the risk of infection in certain men. The vaccine itself did not cause infection.

In 2003, AIDSVAX flunked two large trials — the first late-stage tests of any AIDS vaccine at the time.

It is unclear whether vaccine makers will seek to license the two-vaccine combo in Thailand. Before the trial began, the U.S. Food and Drug Administration said other studies would be needed before the vaccine could be considered for U.S. licensing.

Also unclear is whether Thai volunteers who received dummy shots will now be offered the vaccine. Researchers had said they would do so if the vaccine showed clear benefit — defined as reducing the risk of infection by at least 50 percent.

Those issues, plus how to proceed with future studies, will be discussed among the governments, study sponsors and companies involved in the trial, Kim said. Scientists want to know how long will protection last, whether booster shots will be needed, and whether the vaccine helps prevent infection in gay men and injection drug users, since it was tested mostly in heterosexuals in the Thai trial.

The study was done in Thailand because U.S. Army scientists did pivotal research in that country when the AIDS epidemic emerged there, isolating virus strains and providing genetic information on them to vaccine makers. The Thai government also strongly supported the idea of doing the study.

By MARILYNN MARCHIONE and MICHAEL CASEY, Associated Press Writers.

Early Results: In Children, 2009 H1N1 Influenza Vaccine Works Like Seasonal Flu Vaccine

Early results from a trial testing a 2009 H1N1 influenza vaccine in children look promising, according to the trial sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Preliminary analysis of blood samples from a small group of trial participants shows that a single 15-microgram dose of a non-adjuvanted 2009 H1N1 influenza vaccine – the same dose that is in the seasonal flu vaccine – generates an immune response that is expected to be protective against 2009 H1N1 influenza virus in the majority of 10- to 17- year-olds eight to 10 days following vaccination. These results are similar to those recently reported in clinical trials of healthy adults. Younger children generally had a less robust early response to the vaccine.

“This is very encouraging news,” says NIAID Director Anthony S. Fauci, M.D.” As we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to what we see with routinely used seasonal influenza vaccines made in the same way. It seems likely that the H1N1 flu vaccine will require just one 15-microgram dose for children 10 to 17 years of age. The 2009 H1N1 influenza virus is causing widespread infections among children, so these are welcome results.”

The ongoing NIAID-sponsored trial began in mid-August at five sites nationwide. The trial is assessing the safety and immune responses to one and two doses of either 15 micrograms or 30 micrograms of vaccine. Data from the trial is being compared for three age groups: children 6 months to 35 months old; 3 to 9 years old; and 10 to 17 years old.

The preliminary results are based on blood samples taken eight to 10 days after the first vaccination. Immune responses were strongest among the oldest children, those 10 to 17 years old. In this group of 25 children, a strong immune response was seen in 76 percent who received one 15-microgram dose of vaccine. The immune responses in children nine years old and younger were not as strong. Among 25 volunteers aged 3 to 9 years old, a strong immune response was seen in 36 percent of those given 15 micrograms of vaccine. In the youngest group, 20 children between 6 months to 35 months old, a single 15-microgram dose of vaccine produced a strong immune response in 25 percent of recipients.

“These results are not unexpected and are both similar to what is seen with seasonal influenza vaccines and consistent with what we and our colleagues at the Food and Drug Administration anticipated,” notes Dr. Fauci.

Study investigators are also collecting blood samples from the volunteers approximately three weeks after both the first and second injections. It is anticipated that the immune response to the 2009 H1N1 influenza vaccine will be similar to that of seasonal influenza vaccination and will continue to rise for several weeks following vaccination, says Dr. Fauci. The study is being closely monitored by the trial physicians and staff as well as by an independent safety monitoring committee.

The vaccine being tested in this trial is manufactured by Sanofi Pasteur in Swiftwater, Pa., in the same manner as its licensed seasonal vaccine, which is used every year in millions of children, and is the same formulation recently licensed by the FDA to protect against 2009 H1N1 influenza. Like inactivated seasonal influenza vaccines, the vaccine contains a purified part of a killed virus and cannot cause flu.

NIAID is conducting trials of 2009 H1N1 influenza vaccines through its longstanding vaccine clinical trials network, the Vaccine and Treatment Evaluation Units. Additional information about the NIAID-sponsored clinical trials in children is available in an Aug. 18 Bulletin: http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1pedvax.htm and a Q&A: http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm. A detailed description of the trial protocol is at clinicaltrials.gov: http://clinicaltrials.gov/show/NCT00944073.

For more information, visit www.flu.gov. or visit http://www3.niaid.nih.gov/topics/Flu

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune — mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. For more information, visit http://www.niaid.nih.gov.

About The National Institutes of Health
The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information, visit www.nih.gov.

SOURCE: The National Institutes of Health

September 22, 2009