Vol. 17 •Issue 8 • Page 15
Oriel Therapeutics Starts Testing Its Innovative Drug Delivery System
We’ve come a long way in health care since cavemen concocted a brew of eucalyptus leaves and ground tooth of tyrannosaurus Rex and wafted the resulting aroma in front of an ailing kinsman in an attempt to improve breathing. We’re far more sophisticated.
Today, we use bronchodilators like Alupent, Ventolin, Proventil, Salbuterol and Berotec to enhance breathing for the millions of people impacted by breathing disorders like asthma and COPD around the globe. In fact, we’ve perfected the delivery system so well, that over the past 50 years, most of these drugs have been literally blasted into patients’ lungs, thanks to a bountiful supply of MDIs and nebulizers.
Of course, progress carries a price tag. Our delivery system, using liberal chlorofluorocarbons (CFCs), helped deplete the earth’s protective ozone layer and led to the creation of the 1987 Montreal Accord, which calls for an eventual complete ban on all CFCs.
Enter some innovative technology currently being readied for clinical trials across the pond sometime in the near future, thanks to the brainpower at Oriel Therapeutics Inc. of Durham, N.C. Oriel, an emerging inhaled drug delivery company, has developed a “smart” inhaler that uses an electronic signal to administer a dry powder uniformly within the lungs.
Oriel’s novel approach derives from years of a basic roll-up-your-sleeves kind of hard work attainable only by individuals with special talents, training, experience and dedication.
Professor Anthony Hickey, PhD, an asthmatic with first-hand knowledge of limitations to existing technology, spent over a decade of research in powder dispersion and inhaler design at the University of North Carolina in Chapel Hill.
Timothy Crowder, PhD, developed the drug delivery technology while he was completing graduate studies in Professor Hickey’s laboratories.
They were later joined by Paul Atkins, PhD, a British-educated physical chemist, who hop scotched around the United States and the U.K., working with drug compound experiments at various pharmaceutical firms starting in 1983. He moved exclusively from research roles into the commercial arena in 1997, a switch he refers to jovially today as “Going over to the Dark Side.”
Atkins added to the group his experiences in inhaled drug research at sojourns at Upjohn, Pfizer, Glaxo-Wellcome and the merged drug giant GlaxoSmithKline.
The principals at Oriel Therapeutics first met in the early 1990s at Chapel Hill, and that led to a bonding of minds in quest of a similar goal. With their ideas commingling for the design of an entirely new delivery device for reconfigured therapeutic drugs, the group began to tackle what has become central to an entire corps of perplexing problems confronting the health care community world wide: finding a drug delivery system that will yield consistent outcomes for a wide range of users within a framework of ecological safety. Moreover, the product would have to yield results for patients with diverse diseases. In respiratory care land, that could mean any breathing challenged individual ranging from a premature neonate in an NICU to an end-stage COPDer in a geriatric center.
“One of the biggest challenges has been to develop products that meet FDA requirements consistently,” said Atkins, citing problems with drugs introduced via the MDI-delivery route over the past 20 to 30 years. Difficulties, especially those associated with ozone depletion, have led to increasing regulatory oversight. In some respects, tighter regulations have been a boon to researchers now being commissioned to find new ways to deliver drugs and may in due course prove to be especially beneficial to the greater respiratory care community. It has certainly led to a renaissance in nasal science, explained the British scientist.
Researchers, in the meantime, are left to grapple with other demands unique to health care, namely developing technology that will be inexpensive and easy to use.
PHASING OUT OLD
MDIs were good in that respect for a while, Atkins added, but they are basically reaching the end of the line in effectiveness, and efforts to simply reconstitute existing drugs using environmentally friendly propellants are not all working out as anticipated. Meanwhile, many of the existing MDIs we know will be phased out within the next decade as new products get approved. Many conventional MDIs are already banned in some countries like Japan.
Oriel’s technology centers on three key facets, according to Atkins. It allows for the administration of inhaled drugs without depending on patient effort (something beneficial for the young, the elderly and the physically incapacitated); it uses technology allowing for the eventual administration of a combination of drug products, not simply one drug compound; and the technology can adapt to a number of configurations and be ergonomically intuitive for patient use without changing function and performance.
Oriel’s current goal is to get a commercial version of its inhaler on the market by some time next year. “Much will depend on the drug we use,” said Atkins. Currently the company is focusing its clinical efforts on an asthma drug. “Our first goal is to prove it works and works effectively,” he said.
Down the line, the delivery device, about the size as the existing Discus™, might be tailored for use with CF and COPD drugs. It might even be used to deliver designer drug combinations tailored specifically for an individual patient. “
Three- or four-drug technology would be feasible,” noted Atkins. But any subset of patients would need the technology tailored specifically toward them, because the electronic delivery signals used by the device are currently tailored for individual powders.
In the upcoming clinical study, patients will use the Oriel device at a single study site, most likely somewhere in the United Kingdom, before multi-center studies are undertaken.
For asthmatics and COPDers especially, any effort to deliver drugs more effectively is a boon, since much of the therapeutic value of existing drugs gets lost through improper administration, which results in the drug being deposited in the throat rather than the airways or fails to reach optimal treatment zones within the lungs because particle size will not allow diffusion into smaller passageways. Oriel’s drug system, as yet to be named, is expected to rectify those shortcomings. That will be possible specifically because Crowder went back to the basics to look at the particle level of drugs.
To fund the current clinical studies, Oriel last fall raised $2 million in cash from Pharmaceutical Product Development of Wilmington, Del., and Trudell Medical International of Canada and has received $250,000 in grants from the North Carolina Biotechnology Center and the National Institutes of Health. Principles in the Oriel organization today include Atkins as CEO; Hickey as chief scientific officer; and Crowder as chief technology officer. All are playing pivotal roles in getting the product into clinical trials.
Obviously, we are not headed back to caveman versions of ground eucalyptus leaves as we leave MDIs behind. Encouragingly, what we can expect to evolve will be new technology equipped with the teeth of a Tyrannosaurus Rex. Smart money at the current time is solidly behind devices like that of Oriel Therapeutics.
• For additional information on this product and progress of current clinical studies, contact Daniel Pearson at (919)-557-7890, ext. 13.
You can reach Vern Enge at [email protected].