No, it’s not The Grinch, but organoids are a great Christmas in July gift for the preclinical researchers in your life. Drugmakers spend tons just to get their drugs to Phase I research but could lose big if too many side effects occur in these first rounds of human trials. For instance, only 6.6% of Phase I cardiovascular INDs make it to Phase II. Wouldn’t it be nice if we could test a drug’s effects on say, a model of the human heart? Some biotech companies have recently developed the means to create 3D assays known as organoids—artificially-grown cell structures that can actually mimic organ functions instead of just the compositions of those organs (i.e. older 3D assays.) Watch out for more companies contracting their services to cut down on investment and—more importantly—patient risk.
Yay, we get to write another article about fewer needles in the lives of diabetics! Researchers in London are working on an immunotherapy approach to slow down the progression of Type I Diabetes, which would ideally result in a future where those diabetics won’t have to inject insulin daily. The disease works by attacking insulin-producing cells, so the scientists decided to try to get the lazy part of the immune system that wasn’t stopping that—regulatory T cells—to stop playing video games and get a job! (Sorry. Too close to home?) The scientists proved the safety of this approach in a recent Phase I study, so it will be a while before anything is marketed to the general public, but we just think this immunotherapy stuff is the bee’s knees.
A promising vaccine under development by Sanaria has some malaria strains running scared. The PfSPZ vaccine was shown to not only protect 64% of subjects from contracting the strain of malaria the treatment was developed from, the vaccine also protected 5 of the 6 subjects treated and exposed to a different strain. Sorry subject #6! Oh, and it does all this while affording eight months of protection at >90% efficacy, which no malaria vaccine to date has been able to do. It’s currently in Phase I, though it has been given fast track designation, so if it can survive the arduous clinical trials process it could be a very important tool in the fight to eradicate malaria.
PPD recently announced it is opening a Phase I clinic in Las Vegas. So many questions. Can my remuneration be in the form of a plane ticket home? When you say “healthy” volunteer, how healthy is healthy enough? Will I get a loyalty card like I have at the MGM? All the playful questions aside, this is actually quite interesting. Several years ago, CROs were shutting down Phase I units as fast as people were buying Celine Dion tickets at Caesars Palace. The fact that a large CRO is investing in brick-and-mortar facilities means they see strength in early development pipelines. We’re not sure the unit will be on the Vegas bus tour but it is rumored to be pager-friendly.
Would you recommend a friend or family member participate in a Phase I clinical trial for an experimental medication?
The world wants the Zika vaccine now. The world needs the Zika vaccine now. At least we can say significant steps were taken this week in the right direction. Inovio Pharmaceuticals announced that they will begin Phase I trials of their vaccine in the next few weeks. Also, the US House of Representativesapproved a bill to put forth $1.1 billion to fight the virus, to be voted on later by the Senate. According to Dr. Anthony Fauci, “It’s still a long tunnel that we get to before we get to any vaccine and one that’s safe,” but expect continued global efforts as the disease continues to spread.