Start-Ups Work on Biotech Drugs for Pets

medicine (Photo credit: taiyofj)

medicine (Photo credit: taiyofj)

Judging by some of the heavy action in the world of biotechnology, one could easily conclude that the industry is going to the dogs. Or cats, maybe.

There are start-ups named Nexvet and VetDC, CanFel Therapeutics (as in canine and feline), and even Fetch Pharma.

It’s a new example of pack behavior: Entrepreneurs with pedigrees from companies like Genentech and Amgen are now turning their attention to pets. They hope to develop innovative drugs for dogs and cats like those that have revolutionized the treatment of diseases like cancer and arthritis in people.

“We’ve been drugging ourselves for a long time and more recently we’ve been drugging our kids,” said Oleg Nodelman, an investor in and director of Kindred Biosciences, one of the new companies. “Why shouldn’t our pets have access to medicine?”

They do already, of course. Many of the big pharmaceutical companies have long had veterinary drug divisions. Eli Lilly’s animal division, Elanco, for instance, sells the company’s Prozac antidepressant under the name Reconcile to treat canine separation anxiety.

But the new entrepreneurs say they will be more nimble and do what the big companies are not doing, just as the early human medicine biotech companies did.

The big companies focus more on livestock — edible animals as opposed to petable ones, said Steven St. Peter, chief executive of Aratana Therapeutics, a pet biotech company. Their offerings for pets are mainly vaccines and treatments for fleas, ticks and worms.

The new companies hope instead to treat diseases like cancer and arthritis. Many are trying to develop monoclonal antibodies, which are proteins made in living cells. Such antibodies, like Humira for rheumatoid arthritis and Herceptin for breast cancer, are huge sellers in human medicine but have had almost no role so far in animal health.

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Unreliable research: Trouble at the lab

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Scientists like to think of science as self-correcting. To an alarming degree, it is not

“I SEE a train wreck looming,” warned Daniel Kahneman, an eminent psychologist, in an open letter last year. The premonition concerned research on a phenomenon known as “priming”. Priming studies suggest that decisions can be influenced by apparently irrelevant actions or events that took place just before the cusp of choice. They have been a boom area in psychology over the past decade, and some of their insights have already made it out of the lab and into the toolkits of policy wonks keen on “nudging” the populace.

Dr Kahneman and a growing number of his colleagues fear that a lot of this priming research is poorly founded. Over the past few years various researchers have made systematic attempts to replicate some of the more widely cited priming experiments. Many of these replications have failed. In April, for instance, a paper in PLoS ONE, a journal, reported that nine separate experiments had not managed to reproduce the results of a famous study from 1998 purporting to show that thinking about a professor before taking an intelligence test leads to a higher score than imagining a football hooligan.

The idea that the same experiments always get the same results, no matter who performs them, is one of the cornerstones of science’s claim to objective truth. If a systematic campaign of replication does not lead to the same results, then either the original research is flawed (as the replicators claim) or the replications are (as many of the original researchers on priming contend). Either way, something is awry.

To err is all too common

It is tempting to see the priming fracas as an isolated case in an area of science—psychology—easily marginalised as soft and wayward. But irreproducibility is much more widespread. A few years ago scientists at Amgen, an American drug company, tried to replicate 53 studies that they considered landmarks in the basic science of cancer, often co-operating closely with the original researchers to ensure that their experimental technique matched the one used first time round. According to a piece they wrote last year in Nature, a leading scientific journal, they were able to reproduce the original results in just six. Months earlier Florian Prinz and his colleagues at Bayer HealthCare, a German pharmaceutical giant, reported in Nature Reviews Drug Discovery, a sister journal, that they had successfully reproduced the published results in just a quarter of 67 seminal studies.

The governments of the OECD, a club of mostly rich countries, spent $59 billion on biomedical research in 2012, nearly double the figure in 2000. One of the justifications for this is that basic-science results provided by governments form the basis for private drug-development work. If companies cannot rely on academic research, that reasoning breaks down. When an official at America’s National Institutes of Health (NIH) reckons, despairingly, that researchers would find it hard to reproduce at least three-quarters of all published biomedical findings, the public part of the process seems to have failed.

Academic scientists readily acknowledge that they often get things wrong. But they also hold fast to the idea that these errors get corrected over time as other scientists try to take the work further. Evidence that many more dodgy results are published than are subsequently corrected or withdrawn calls that much-vaunted capacity for self-correction into question. There are errors in a lot more of the scientific papers being published, written about and acted on than anyone would normally suppose, or like to think.

Various factors contribute to the problem. Statistical mistakes are widespread. The peer reviewers who evaluate papers before journals commit to publishing them are much worse at spotting mistakes than they or others appreciate. Professional pressure, competition and ambition push scientists to publish more quickly than would be wise. A career structure which lays great stress on publishing copious papers exacerbates all these problems. “There is no cost to getting things wrong,” says Brian Nosek, a psychologist at the University of Virginia who has taken an interest in his discipline’s persistent errors. “The cost is not getting them published.”

First, the statistics, which if perhaps off-putting are quite crucial.

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Topical use of arthritis drug provides relief for dry eye disease

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Research study online in JAMA Ophthalmology may herald new era of new highly targeted molecular treatment for common condition

Dry eye disease (DED) is a common condition that causes discomfort, visual disturbance and potentially damaging ocular surface inflammation that greatly impacts a person’s quality of life. An estimated nine million people in the United State alone suffer from significant DED; millions more may have milder forms or experience discomfort when exposed to low humidity or contact lens use. DED, the most common reason people visit ophthalmologists, is estimated to cost $55 billion in annual direct and indirect costs to society in the nation alone.

In a new study, researchers from the Massachusetts Eye and Ear, Harvard Medical School, and Brigham and Women’s hospital show that topical anakinra (Kineret; Amgen Inc.), a recombinant version of human IL-1Ra approved for treatment of rheumatoid arthritis, significantly reduced dry eye symptoms. Topical use of a protein-based biologic agent in treatment of DED is unprecedented and may herald a new era of highly targeted topical molecular treatments for ocular surface disease. The results of this clinical trial are described online first in JAMA Ophthalmology.

“We began looking at the possible therapeutic effects of IL-1Ra over 10 years ago in my laboratory,” said Reza Dana, M.D., MSc., M.PH., senior author. “This clinical trial was a significant milestone in our research. The results clearly show us not only that we can possibly help the millions of people affected by dry eye disease worldwide, but that biologics such as this have the potential to provide targeted therapies for other ocular ailments, as well.”

Early studies have shown that DED is associated with significant overexpression of inflammatory cytokines, including interleukin 1 (IL-1), in the eye. However the options to treat the inflammatory component of DED have been limited and some of these involved adverse effects. Anti-inflammatory medications such as tetracycline derivatives, topical corticosteroids, and cyclosporine A that have been successfully used in the treatment of DED downregulate the production of IL-1 and upregulate the production of IL-1 receptor antagonist (IL-1Ra) at the ocular surface. The IL-1Ra suppresses IL-1-mediated inflammation by completely inhibiting the binding of IL-1a and IL-1b to IL-1 receptor I. Topical IL-1Ra has been successfully used to treat experimental rodent models of corneal transplant rejection, dry eye disease, allergic conjunctivitis and alkali burn-associated ocular inflammation.

The researchers performed a randomized, double-masked clinical trial designed to assess the safety of efficacy of topical IL-1Ra in patients with DED. Seventy-five participants in the 16-week study were randomly allocated in the 2:2:1 ratio to receive eye lubricant (artificial tear), 2.5% of anakinra or 5% of anakinra. Patients found the anakinra was well tolerated and was significantly more effective than the eye lubricant in improving the signs and symptoms of DED. Anakinra at 2.5% was four times more likely than the eye lubricant to bilaterally eliminate corneal staining, a clinical measurement of ocular surface disease. Topical anakinra also significantly reduced dry eye symptoms six times more effectively than the eye lubricant, which is capable of independently improving the signs of DED. Moreover, termination of anakinra (but not the lubricant) application at week 12 lead to a clear trend toward increased symptoms between weeks 12 and 16, confirming the therapeutic effect of the drug.

“We have never seen results such as this before in a trial to treat dry eye disease. We possibly have found a safe, well tolerated eye drop that can treat the underlying cause of dry eye rather than just temporarily mask the symptoms. We are excited about the positive results we saw in the data and with our patients who found relief in their symptoms and were able to return to some of their normal daily activities,” Dr. Dana said.

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Supercomputer helps breakthrough in cancer research

Breakthrough in cancer research that reduces the analysis time from two months to only 47 seconds per patient,

One of the greatest advantages of supercomputing is that it offers researchers tools to study some of the world’s most deadly diseases more effectively than traditional computing methods. Patrick Soon-Shiong, chairman of NantHealth and the Chan Soon-Shiong Institute for Advanced Health, recently achieved a breakthrough in cancer research that reduces the analysis time from two months to only 47 seconds per patient, according to the institute.

The institute explained that oncologists can now compare nearly every cancer treatment option available before the patient undergoes treatment. This is based on genetics, cost and risk.

By using a supercomputer, Soon-Shiong conducted real-time analysis of more than 6,000 cancer genomes from 3,022 U.S. patients in only 69 hours. Traditional research of this magnitude would have taken between eight and 10 weeks, the institute said.

“We can’t reduce the cost of care and improve outcomes in cancer if we don’t have the capability to know the right treatment for the right patient before treatment begins,” Soon-Shiong explained. “We needed a national supercomputing infrastructure that brings genomic medicine into clinical practice. By placing supercomputers in the hands of physicians, that need is now a reality.”

Supercomputing making research progress a reality

Supercomputing projects are taking place around the world in hopes of finding cures for a number of ailments. ABC News reported earlier this year that Rutgers University’s high performance computing center is one of the most important systems because researchers at the university hope to make significant strides in cancer, genetics and medical imaging, among other areas.

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