Hollis-Eden Pharmaceuticals Inc. licensed certain intellectual property from Pharmadigm Inc. and the University of Utah to use in its program of hormonal regulation of genes to treat disease.
"It allows us exclusive worldwide rights to intellectual property that may be important to our development of immune-regulating hormones," said Hollis-Eden Vice President of Business Development Bob Marsella.
Hollis-Eden, of San Diego, is not disclosing the terms of the agreement, Marsella said.
"It's just that we have quite a lot of intellectual property in the area of immune-regulating hormones, and this allows us a stronger patent position and freedom to practice in this area," Marsella said.
The intellectual property from Salt Lake City-based Pharmadigm also would allow Hollis-Eden to expand its IRH research in relation to specific indications, Marsella said, although he would not disclose those. Privately held Pharmadigm is an early stage company focused on inflammation and immunology,
"These compounds cross over into a lot of indications," he said, noting that the company thought it would be "prudent" to have the intellectual property in place going forward.
The key patents licensed under the agreement originally were licensed to Pharmadigm from the University of Utah and are related to inventions by Raymond Daynes and Barbara Araneo. Daynes is a consultant to Hollis-Eden, while Araneo is a founder of Pharmadigm and serves as its senior vice president for research and development.
Hollis-Eden is developing hormone replacement therapies for infectious diseases, aging immune systems, autoimmune diseases, metabolic diseases and radiation/chemotherapy protection. By controlling hormone levels, some of which are depleted as the body ages, the company hopes to allow re-establishment of proper functions across a number of regulatory pathways, which in turn may allow the body to control progression of certain diseases.
Hollis-Eden has three compounds in preclinical or clinical trials, and two others in investigational studies. HE2000 is in Phase II studies for HIV/AIDS, malaria, hepatitis B and hepatitis C. HE2500 is in a Phase II study for metabolic syndrome, and in preclinical studies for a variety of indications. HE2200 is in Phase II studies to treat the aging immune system.
"We're in a trial right now [with HE2200] in the elderly to see if we can enhance the antibody production in the hepatitis B vaccine," Marsella said. "We're testing this in hepatitis B, because generally they've never been exposed to hepatitis B."
With the trial, the company hopes to "reverse immunosenescence," he said.
The company said earlier this month that it was cleared by the FDA to begin a Phase II trial of HE2200 to assess its effect on patients with elevated cholesterol and other lipid disorders. That trial will involve 60 patients.
Aeson Therapeutics Inc., of Tucson, Ariz., is the exclusive license-holder of HE2500, and Hollis-Eden owns a 21 percent stake in Aeson. In October 2000, Hollis-Eden also agreed to an exclusive 30-month option to acquire the remainder of Aeson at a pre-determined price.
Hollis-Eden's stock (NASDAQ:HEPH) fell 10 cents Thursday to close at $5.41.