Aurogen will unleash Alzheimer’s drug

FORT COLLINS – Millions of people afflicted with two crippling diseases may find hope in a new drug treatment that has emerged from a Colorado State University biomedical laboratory.

And the founder of Aurogen Inc. and his newly hired CEO are working to bring the potentially life-saving product to market as soon as possible.

The illnesses that the new drug targets – Alzheimer’s disease and diabetic neuropathy – potentially afflict more than 32 million people in the United States alone, said Douglas Ishii, Aurogen’s founder and a professor of biomedical sciences at CSU.

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Beyond the human toll, the effects of the two diseases can be measured dramatically in dollars: Treatments for 12 million Alzheimer’s patients cost $100 billion yearly, and another $120 billion is spent to treat 20 million people with diabetes. Both numbers are swelling rapidly.

“It’s an assault on our nation’s public health system,” Ishii said. “In the near future, it will become a fundamental drag on our economy.”

Ishii has brought aboard a doctor-turned-entrepreneur, Boulder resident Robert Caspari, M.D., to push the new treatment into a multi-billion-dollar market. Caspari is a veteran strategist with biotechnology companies, having most recently served as executive vice president and chief medical officer for Myogen Inc., a Westminster-based company that successfully developed drugs for cardiovascular diseases.

“You always want to be involved in something where you can make a difference,” Caspari said. “Meeting Doug and seeing what kind of person he is, and looking at his work showed me that opportunity.”

The IGF key

Aurogen’s core technology is a protein called insulin-like growth factor, or IGF, that proves to be a key in the growth of neuron connectors that Alzheimer’s and diabetic neuropathy patients lack.

In diabetic neuropathy cases, nerves die back from the extremities – fingers and toes first – resulting in injuries due to a patient’s inability to feel pain. Often, gangrene infections result, and consequently lead to 80,000 limb amputations yearly in the United States.

Alzheimer’s is marked by the death of synapses, the connectors in the brain that transmit information.

“The tragedy of Alzheimer’s is that people lose their fundamental identity as human beings,” Ishii said. “We think that can be prevented.”

Ishii’s work during more than two decades has explored the role of IGF in preventing the death of neurons, first in a laboratory at Columbia University in New York where he was a professor.

Diabetic neuropathy was the first focus of his research, and his laboratory team showed that boosting IGF levels in diabetic animals could forestall the death of nerve tissues independently of blood sugar levels that were thought to be the key factor in the disease’s progress.

“Test after test showed that replacing the IGFs, pushing that level back toward normal, prevented neuropathy,” Ishii said.

When Ishii was recruited to continue his work at Colorado State University in 1991, his interest turned toward the role of IGFs in brain activity and the health of synapses, where learning and memory are encoded.

Some of Ishii’s findings were pushed forward by Suzanne Craft, a neurobiologist at the University of Washington, who discovered in 1998 that spinal fluid in Alzheimer’s patients had abnormally low levels of insulin. That research spurred Ishii and his CSU team to conduct animal tests, using diabetic rats as subjects, to investigate the role IGFs play in learning and memory.

Ishii’s invention, wrapped now in patents that he has secured over the past few years, is a protein antibody that is injected under the skin, crosses the blood-brain barrier and works to raise IGF levels in brain tissue.

Pathway to market

Enter Caspari, “a strategic thinker,” as Ishii describes him, who was recruited with the help of former Myogen CEO J. William Freytag.

Caspari’s experience practicing internal medicine combines with his work in developing and commercializing new drug treatments with a series of biotechnology and pharmaceutical companies including Novo Nordisk, Shering Plough and Somatogen as well as Myogen.

His tasks now are to build a management team, raise money and forge strategic partnerships to push Ishii’s products out of the laboratory and into a marketplace where needs are critical.

“We believe in this story, and that’s a big start,” Caspari said. “We’re hoping it will resonate as we visit a whole lot of venture capital people. …There’s a lot of focus in this area. Alzheimer’s is in the public eye, and that public awareness is critical.”

While raising money, Caspari will also direct the filing of an investigative new drug, or IND, application with the federal Food and Drug Administration. Ishii’s long record of animal testing will shorten the pathway to development of a market-ready drug treatment, Caspari said.

“All of the animal work that is typically done with a new company has already been done,” Caspari said. “If we’re able to go directly to human trials, getting the IND, we’re looking at about a two-year process.”

While other researchers are pursuing similar paths in the direction of an Alzheimer’s cure, Caspari said his is confident that the size of the burgeoning market – one that will triple over the next few decades – plus the unique characteristics of Ishii’s product will raise the chances of success.

“Doug’s approach is unique,” Caspari said. “His understanding of brain chemistry, and of the brain as a diabetic organ, is the approach that’s patented by Aurogen. What Aurogen is looking at has the best chance.”

Interviews with Ishii and Caspari show that throughout the research, fundraising and securing of partnerships to commercialize Aurogen’s products, passion to meet a growing health-care and social need is the guiding factor.

“The passion comes because this is a huge problem facing mankind,” Caspari said. “It comes with the graying of the population. What’s the point of living longer if your mind goes? We need to find ways to keep the brain as healthy as our healthier bodies as we age. Our passion is not to make money out of this, but to solve this problem.”