Editor’s note: BioWatch is a regular feature on Fridays in LTW.Will work done at BioStratum soon lead to a diagnostic test that early on determines whether someone has cancer or a benign tumor?
BioStratum announced a deal earlier this week with DakoCytomation A/S under which the Danish company will license research that could lead to the development of a diagnostic cancer test.
To identify an invasive cancer early and get it treated would be a boon to patients and to medical science, BioStratum says.
“The diagnostic test to be developed to identify cancers at an earlier stage than possible before would permit treatment of a less radical nature, which would be of less danger to the patient,” Mark Turner, director of business development for BioStratum, tells Local Tech Wire.
“This would be a useful tool to triage patients,” he adds. “It’s still to be proven, but this perhaps could be the earliest sign of a cancer developing.”
Work already has been done on a variety of animal models, and Turner says the results were encouraging enough to take the test to the clinical trial stage.
The deals means licensing fees and royalties down the road, should the test be developed, but the companies wouldn’t disclose any details. BioStratum did retain the rights to develop any therapeutic treatments that might evolve from the cancer research.
BioStratum’s research centers around the basal lamina — the thin membrane that surrounds cells and tissues and has what the company calls “a profound effect” on the activity of those cells and tissues. Since it is crucial to maintaining cell health and also is involved in fighting disease, keeping the basal lamina healthy is a key part of BioStratum’s work.
Researchers working with BioStratum at the Karolinska Institute in Stockholm, Sweden, discovered that laminin-5, a so-called macromolecule in the adhesion and migration of cell types, has links to cancer. The diagnostic test involves “staining” tissue with BioStratum’s monoclonal antibody called MetaStain. BioStratum says that the degree to which MetaStain binds to the laminin-5 has “shown to predict a cancer’s invasive potential.”
“We consider this license agreement a further validation of our research on the basal lamina,” said Dr. Claus Kuhl, BioStratum’s chief executive officer in a statement.”
Jes Ostergaard, president and CEO of DakoCytomation, added that the development of a diagnostic test “will allow a more targeted treatment for the patient thus improving the outcome — be it a cure or prolonged life.”
The companies hope to begin marketing the antibody for research in the first half of this year followed by the diagnostic test.
Pace picking up
BioStratum has struck another deal with a Japanese firm and is talking about a license with another firm about a possible treatment for Alport Syndrome, an inherited kidney disease. The drug BioStratum has developed, Pyridorin, was granted “fast track” status by the FDA last July and is currently in Phase II clinical trials.
The market for Pyridorin could be huge. Fifteen million Americans have diabetes, 10 percent of which have Type 1 and of those 40 percent will develop kidney disease. A significant number of Type 2 diabetes sufferers also will be struck by kidney disease.
At some point, Turner explains, BioStratum will be looking to work with other firms to take the drug to market. To develop and deploy resources such as sales and marketing to handle such a large market is a daunting task. “We will look in the United States and Europe for partners,” he says.
Angiocol, a possible anti-cancer drug, was approved for Phase I clinical trials last year.
BioStratum, which closed on $20 million last April, has other possible drug candidates for cancer, diabetes, diabetic complications and tissue regeneration under development.