TriMed Research Inc. is looking to take a pivotal step in its young history as it develops operations to commercialize a naturally occurring mammary gland protein for therapeutic use in both humans and animals.
The Omaha, Neb.-based company, which is based on research from the University of Nebraska Medical Center, believes its technology, built on the discovery of mammary-associated amyloid - also called MAA protein - will lead to such treatments. The compound has shown an ability to prevent bacteria and viruses from adhering to the gut. Findings have demonstrated that synthetic versions of MAA are bioactive and begin protective processes in the intestine, meaning its use might reduce bacterial and viral gastrointestinal infections.
"This concept is interesting, and if it works out, this could well be a model for other spin-offs from the university," CEO David Winter told BioWorld Today. "They found a very interesting protein that was isolated from colostrum [the first milk created by a mammalian mother after birth]. And within this protein, they identified a set of species-specific peptides that have some very strong effects in vitro."
Specific applications include uses for treating infectious diarrhea in infants and newborns, as well as the same indication in newborn farm animals, slowing the side effects of cancer treatments and preventing travelers' diarrhea. The company's initial research will focus on diarrhea in infants, which Winter said causes up to 1.2 million hospitalizations in the U.S. each year in children less than the age of 5.
"Without adherence and colonization, these things don't get started," he added. "For practical purposes, you're indirectly modifying infection."
Winter said the peptide acts by increasing production of the mucin 3 gene, which when lacking in human and animal newborns can prove a weak link in immunological protection. But MAA jumpstarts such production, helping to prevent the E. coli bacteria and the rotavirus from sticking to the gut's inner walls. Tissue cultures in single human cells have demonstrated its action, as has organ culture research performed at the Royal Free Hospital in London.
MAA was discovered by Thomas McDonald, TriMed's chief scientific officer and a professor at Nebraska. The company operates as a virtual entity, with Winter in California, its president in Ireland and seven part-time employees supported by the university. Established about two years ago as a joint venture between Nebraska, its technology transfer company UNeMed Corp. and Tridelta Development Ltd., TriMed aimed itself first at a lead indication that Winter did not view as commercially viable. He came on board as CEO last September as part of a reorganization to sharpen TriMed's therapeutic and business focus.
"We restructured the whole company and have been working very hard to make sense from commercial and scientific points of view," Winter said. "We put it together with a new board of directors, and for all practical purposes it's a new company."
A medical doctor, Winter's business background includes stints running various companies, including SangStat Medical Corp., of Fremont, Calif.; GenPharm International Inc., of Palo Alto, Calif.; and the Sandoz Research Institute in East Hanover, N.J. Most recently he ran his own consulting business, through which he initially began working with TriMed, and served as the medical director for a Cincinnati-based contract research organization.
In his latest capacity, he is looking for early venture capital backing for animal research to serve as the basis of a pre-IND meeting with the FDA. To date, TriMed is self-supported through employee resources and courtesy of a bill from the university for maintaining the intellectual property underlying MAA - there is one patent issued and nine others pending. Winter presented TriMed's story at this week's BIO Mid-America VentureForum in St. Louis.
Winter's experience has brought him a businesslike attitude. He said that from the time funding is secured, "if we can't get a meeting with the agency and present all this stuff within two years, they really ought to close the company down. It's very unusual to go at it that way, but I've been through this before and we either have it or we don't, and there's no sense fooling around with it."
But should the program succeed and result in an audience with the FDA, Winter said TriMed would look to partner through a collaborative arrangement. Envisioning three or four species-specific products from the program, he said potential suitors already are interested in any forthcoming in vivo efficacy data.
TriMed can support much of the in vivo research at the university, though a portion also would be carried out through other research operations.
The non-antibiotic compounds, which would be delivered orally, hold promise in avoiding resistance associated with antibiotics. At the same time, Winter said a non-antibiotic product would hold appeal in the European Union for uses in animals.
"The reason I stress its use in multiple species is that this has some very real veterinary applications, especially in a farm state like Nebraska," he said. "I've heard estimates of $1.3 billion a year lost in herd animals at birth around the country."