Drug developer seeks Bermuda clinical trial
One of the unpleasant aspects of diabetes is that wounds are slow to heal, creating the potential for serious infections and even amputations.
Given the prevalence of the disease in Bermuda, it’s an issue that is all too familiar in many Bermudian households.
Relief may be on the way, however, from a new antimicrobial drug that has already found success in small-scale clinical trials in the United States.
Steve Parkinson, chief executive officer of Lakewood-Amedex, the company behind the product, is in Bermuda this week for two main reasons: to try to organise a clinical trial on the island and to raise capital from investors to fund the product’s progress through its testing stages.
“Bermuda is one of the best places in the world to conduct a clinical trial, because it has one of the highest rates of diabetes-related amputations per capita in the world,” Mr Parkinson said.
This week, he had a series of meetings scheduled with doctors, including Annabel Fountain and Ewart Brown, as well as David Burt, the Premier, and prospective investors.
Mr Parkinson, a British microbiologist, said the growing incidence of antibiotic-resistant bacterial infections was one of the biggest challenges facing the medical community today. He believes that his company’s new class of antimicrobials, called bisphosphocins, can be part of the solution.
For diabetes patients with slow-healing wounds, Mr Parkinson believes the product could make life easier.
“Diabetes ulcers are very difficult to cure, partly because the blood supply tends to be poor and so is not bringing in what the body needs to deal with it,” Mr Parkinson said.
“So the wound can get infected not only with bacteria, but with yeast and fungus.”
In tests, bisphosphocins have proved effective against many kinds of bacteria, as well as yeast and fungi. Florida-based Lakewood-Amedex says it has modified these compounds into forms that are lethal to a wide range of microbes while being safe for humans.
They have potential to treat ailments that have proved challenging to treat in a quick and effective way, particularly among those with weakened immune systems, whether through age or illnesses like diabetes.
These include bladder infections, mouth ulcers suffered by cancer patients, lung infections suffered by cystic fibrosis patients with weakened immune systems, as well as diabetes wounds.
They have also proved effective against bacteria including Methicillin-resistant Staphylococcus aureus, better known as MRSA, which causes infections that are difficult to treat because of MRSA’s resistance to some antibiotics.
The compound has also killed the microbes that cause tuberculosis and anthrax, as well as Clostridium and Pseudomonas, the bacterium that can cause chest infections in people with weakened immune systems.
Bisphosphocins are administered at the site of infection and kill rapidly by destabilising the bacterial cell membranes.
Mr Parkinson reckons it will take about three years to complete clinical trials necessary to get the products approved for use.
“Efficacy and safety are the key factors in getting a new drug to market,” Mr Parkinson said. “It’s easy to tell whether a drug is killing bacteria. It’s not like testing new treatments for Alzheimer’s or cancer, when the trials can take many years.”
Lakewood-Amedex has already invested around $22 million over the past ten years to develop and test its bisphosphocins and is now seeking to raise private financing of up to $30 million more. This week Mr Parkinson has been doing the groundwork to make Bermuda the place to raise non-US capital for the business, including investments from Bermuda residents.
The potential of bisphosphocins was discovered by the late Roderick Dale, a biology professor who earned a doctorate in molecular biophysics and biochemistry from Yale.
Dr Dale was working on “gene-silencing” technology and its potential for slowing the growth of the MRSA bacterium.
“Completely by accident, he discovered that these compounds were extremely effective at killing MRSA,” Mr Parkinson said. “It was just like Alexander Fleming discovering penicillin by accident and it could end up benefiting just as many people, in my opinion.”
Ten years of research have gone into developing a Lakewood-Amedex’s portfolio of drug candidates, protected by 63 issued patents.