Potential New Malaria Vaccine Tests Poorly

Posted: January 1st, 2013 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , , | Comments Off on Potential New Malaria Vaccine Tests Poorly

A GlaxoSmithKline malaria vaccine posted surprisingly lackluster results in a Phase III trial, putting a damper on solid results from previous studies. The vaccine against the mosquito-borne illness proved only 30% effective when given to African children in a clinical trial.

Still, GSK plans to move forward with development of the vaccine. The trial included 6,537 babies aged 6 to 12 weeks; the vaccine offered “modest protection,” knocking down episodes of the disease 30% compared with the immunization with a control vaccine.

“The efficacy is lower than what we saw last year with the older 5-17 month age category, which surprised some of us scientists at the African trial sites,” Dr. Salim Abdulla, a principal investigator for the trial from the Ifakara Health Institute in Tanzania, said in a release. “It makes us even more eager to gather and analyze more data from the trial to determine what factors might influence efficacy against malaria and to better understand the potential of RTS,S in our battle against this devastating disease.”

In 2010, malaria caused an estimated 655,000 deaths, mostly among African children, the World Health Organization says.

The Phase III trial, completed in conjunction with PATH Malaria Vaccine Initiative, was backed by $200 million from the Bill & Melinda Gates Foundation. Bill Gates, whose organization commits billions of dollars to improving global health, said the study marked an important milestone.

“The efficacy came back lower than we had hoped, but developing a vaccine against a parasite is a very hard thing to do,” Gates said in a statement. “The trial is continuing and we look forward to getting more data to help determine whether and how to deploy this vaccine.”

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Corporate-Non Profit Partnership Developing Tuberculosis Vaccine

Posted: October 30th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , | Comments Off on Corporate-Non Profit Partnership Developing Tuberculosis Vaccine

GlaxoSmithKline will work with nonprofit biotech Aeras to test a tuberculosis vaccine in Africa and India, making headway in developing new ways to prevent the disease.

After promising early-stage clinical trials of GSK’s TB vaccine candidate, the partners will conduct a Phase IIb trial in Kenya, Indiaand South Africa next year pending approvals from authorities. Both GSK and Aeras will provide resources to test the vaccine candidate in healthy adults between ages 18 and 50.

“When considering the massive public health impact and costs to society of neglected diseases including tuberculosis, global financing for R&D remains critically low in this area,” Jim Connolly, president and CEO of Aeras, said in a release. “Working in partnership with GSK–sharing resources, capabilities and know-how–affords us the opportunity to conduct this pivotal, multicountry proof-of-concept trial, getting us that much closer to potentially one day having a TB vaccine that could protect adolescents and adults from one of the world’s deadliest infectious diseases.”

The TB vaccine Bacille Calmette-Guerin (BCG) prevents some forms of the disease, but not pulmonary TB–and that’s the one responsible for the majority of infections and deaths. GSK and Aeras plan to use their candidate in conjunction with BCG.

New Attempt to Create Staph Vaccine Begins

Posted: October 25th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , | Comments Off on New Attempt to Create Staph Vaccine Begins

Pfizer, GlaxoSmithKline and NovaDigm Therapeutics are each in search of a vaccine to stop methicillin-resistant Staphylococcus aureus, a staph infection that kills more people in the U.S. than skin cancer, Bloomberg reports.

The drugmakers take up the task after two other companies failed to make an effective vaccine–most recently Merck in 2011.  The staph infection can cost as much as $8 billion a year to treat.

“It’s very clear we need a vaccine, and we need it soon,” Robert Daum, a pediatrics professor at the University of Chicago and principal investigator at the school’s MRSA Research Center, told Bloomberg.  “The challenge is, we don’t really know what makes people immune to staph infections.”

The vaccines from the three companies are in early stages in the pipeline, working through the first of three phases typically required for market approval. Pfizer has two vaccines in early trials, while GSK has completed its first-stage trial of a four-component vaccine. NovaDigm completed two Phase I trials that showed its therapy, NDV-3, is safe in humans.

Generally, benign Staphylococcus aureus bacteria live on people’s skin and in their nasal passageways, Bloomberg reports.  The bacteria can enter the skin through cuts, sores, catheters and breathing tubes, making infection common in hospitals and nursing homes. MRSA kills more than 11,400 Americans a year.

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Vaccine Manufacturers Begin Production of 2012-2013 Flu Vaccine

Posted: September 27th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on Vaccine Manufacturers Begin Production of 2012-2013 Flu Vaccine

The FDA green-lighted influenza vaccines from all 6 vaccine manufacturers licensed to produce and distribute in theU.S., making way for the 2012-2013 flu season.

The products from the big 6–CSL, GlaxoSmithKline ($GSK), ID Biomedical, AstraZeneca’s ($AZN) MedImmune, Novartis ($NVS) and Sanofi Pasteur–will include strains for A/California/7/2009 (H1N1)-like virus, A/Victoria/361/2011 (H3N2)-like virus and B/Wisconsin/1/2010-like virus. The H1N1 virus matches what manufacturers included during the last season, but the H3N2 and B viruses differ.

Sometimes the virus strains predicted to circulate and those that actually make the rounds don’t line up. But even if the vaccines and circulating strains aren’t identical, the vaccines can reduce the severity of the illness or help prevent influenza-related complications, according to an FDA release.

“The best way to prevent influenza is by getting vaccinated each year,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “It is especially important to get vaccinated this year because two of the three virus strains used in this season’s influenza vaccines differ from the strains included in last year’s vaccines.”

Seasonal influenza kills more than 36,000 people and hospitalizes 200,000 more each year in the United States, according to National Institutes of Health’s National Institute of Allergy and Infectious Diseases.

$34 Million in Funding for a Cancer Vaccine

Posted: August 28th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , , | Comments Off on $34 Million in Funding for a Cancer Vaccine
The Human Body -- Cancer

The Human Body — Cancer (Photo credit: n0cturbulous)

PsiOxus Therapeutics amassed $34 million for its Series B. The round will allow the London-based company to move forward with clinical development of a systemically available oncolytic vaccine for the treatment of colorectal and other forms of cancer, ColoAd1, through a series of Phase I and Phase II clinical trials, according to a release.

The lead vax is designed to replicate in and kill only cancer cells. The infected cells then reproduce, fanning out as cancer-fighting agents. The so-called “self-amplifying” cancer therapy both kills tumors and acts as a cancer vaccine.

Money for the trials comes from existing investors, Imperial Innovations Group and Invesco Perpetual. And PsiOxus has brought on new investments from GlaxoSmithKline’s venture unit SR One and Lundbeckfond Ventures.

“This financing comes at a pivotal time for our company as we move our cancer portfolio from early- to mid-stage clinical development,” said Dr. John Beadle, CEO of PsiOxus, as quoted in a release. “The new funding will enable key clinical trials to demonstrate the safety and proof of efficacy of these products in the clinic and to highlight the effectiveness of our research and development program.”

The first clinical trial of ColoAd1 will take place later this year in patients with metastatic solid tumors.