GlaxoSmithKline's Experimental Shingles Vaccine Hits Goal In Late-Stage Study
Published: Dec 19, 2014
December 18, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
GlaxoSmithKline today announced that the company’s vaccine for shingles met the primary endpoint in its phase III study. The investigational vaccine, referred to as HZ/su, reduced the risk of developing shingles by 97.2 percent in adults 50 years or older as compared to the placebo.
The study, entitled the ZOster Efficacy study (ZOE-50), began in August 2010 and involves more than 16,000 people in 18 countries. “It’s great news that the ZOE-50 trial has met its primary endpoint,” Alain Brecx, the vaccine development leader at GSK, said in a statement. “If approved, this candidate vaccine may offer an important option for the prevention of shingles, a painful disease that negatively impacts peoples’ health and quality of life.”
In addition to the high efficacy of the vaccine, its side effects are mild. Patients in the trial experienced side effects that included local reactions, such as pain, redness, and swelling at the injection site and systemic symptoms, such as muscle pain, fatigue and headache.
Shingles develop when the latent chickenpox virus (varicella zoster virus or VZV) is reactivated. The development of a painful, itchy rash on one side of the body marks the onset of the disease. The disease can eventually cause scarring, vision complications, secondary infection, nerve palsies and postherpetic neuralgia (PHN).
Anyone who has had chicken pox could develop shingles. In the U.S., 99.5 percent of people who are 40 years of age and older have been infected with VZV—the chicken pox virus—and are therefore at risk for shingles, according to the U.S. Centers for Disease Control and Prevention. In addition, almost one out of three people in the U.S. will develop shingles during their lifetime, with the individual risk increasing sharply with age.
GSK’s vaccine combines a protein found on the shingles’ virus with an adjuvant system to boost the body’s immunological response to the virus. The U.S. biotech firm Agenus contributed to the adjuvant system. “We are thrilled with the results of this important study,” said Chief Executive Officer of Agenus Garo Armen in a statement. “The results indicate unprecedented protection against shingles,” he continued. Agenus is entitled to royalties from sales of the vaccine, if the vaccine is approved and commercialized.
The success of the shingles vaccine for GSK indicates that its new strategy to focus on consumer products and vaccines is on track. In April 2014, GSK agreed to sell its cancer drugs to Novartis for $16 billion and to buy Novartis ’s vaccine business for $7.1 billion. Chief Executive Officer of GSK, Andrew Witty, addressed the issue in an April interview with Bloomberg Television. “It gives us much more of a durable cash flow profile in the future,” he said. “This is a very rational, sensible way to crystallize the value of the pipeline we’ve developed.”