An émigré scientist from the former Soviet Union
is working to develop a new treatment for
diarrhea based on a century-old remedy commonly
used in his former homeland.
Alexander Sulakvelidze, chief scientist for
privately held Baltimore biotech Intralytix,
says the bacteriophage-based probiotic
preparation shows promise for managing shigella
infections, a "significant worldwide cause of
diarrheal disease" — and apparently the U.S.
Army agrees.
The company recently received a $100,000
phase 1 Small Business Technology Transfer grant
from the Pentagon to develop the treatment, an
alternative to antibiotics.
Shigella are "major gastrointestinal tract
pathogens of particular concern" to the Army
because U.S. troops are often stationed in
countries where the disease is widespread, said
Sulakvelidze, the company's principal
investigator for the contract, in a statement.
There are about 164.7 million cases of
shigellosis worldwide, almost entirely in
developing nations, according to the World
Health Organization. About half a million
visitors from industrialized nations to
developing nations contract the infection
annually, and about 1.1 million people die from
it each year, 61 percent of whom are children
younger than 5.
There is no vaccine for shigellosis, and some
strains of it have developed resistance to
antibiotics, according to the federal Centers
for Disease Control and Prevention.
Bacteriophages — highly specific viruses that
infect bacteria — may be used to target
"problem" bacterial species in the human
gastrointestinal tract, according to
Sulakvelidze.
"I'm so excited because these are brand-new,
never-done-before" treatments, he said in an
interview. "These viruses are the most abundant
organisms on the planet. They're everywhere."
Because the bacteriophages kill specific
bacteria, they were used "almost immediately in
the early 20th century after their discovery,"
he said. Their specificity led to many
successes, but also failures.
The discovery of antibiotics largely
displaced bacteriophages as a treatment option
for bacterial infections, but more in the U.S.
and Western Europe than in the former Soviet
Union and other Eastern European nations,
Sulakvelidze said.
"I personally have taken them for therapeutic
purposes, and never thought twice about them
when I came to the U.S.," he said.
When a physician friend said he was having
trouble treating a patient who had developed an
antibiotic-resistant bacterial infection, "it
dawned on me that they don't know about this
alternative to antibiotics here," Sulakvelidze
said.
Intralytix was the first company to receive
approval from the Food and Drug Administration
for food-safety applications for bacteriophages,
he said. Now, the company is expanding into
human therapeutics.
The oral treatment would be used preventively
as a probiotic approach — somewhat akin to how
active cultures in yogurt work in the intestinal
tract to create beneficial flora — but
specifically targeting potential shigella
infections, he said.
"We started with shigella because of the
mind-boggling mortality, 1 million a year,"
Sulakvelidze said. The impact of a successful
treatment "could be staggering in the developing
countries."
FDA approval is a long ways off. In fact,
clinical trials likely won't start for at least
three years, he said.
Still, Sulakvelidze is buoyed by the new Army
contract, which he acknowledged is fairly small.
It could lead to a phase 2 contract, which could
be "significantly larger," he said. The company
also has grant applications pending with the
National Institutes of Health as it gets closer
to conducting trials.