Deltanoid and Beyond: Madison Legend DeLuca Has More “D” To Play

Xconomy Wisconsin — 

Hector DeLuca is the embodiment of nearly a century of University of Wisconsin research into Vitamin D, and he’s working to extend that reach for at least another generation or two.

Now in his mid-80s, DeLuca is the CEO and president of a small Madison, WI, biotech, Deltanoid Pharmaceuticals. He’s also the university’s former biochemistry department chair. As professor emeritus, he still runs a lab on campus a 15-minute walk away from Deltanoid—or maybe more if it’s a football Saturday and the Badgers are home, as the lab and the Deltanoid office are on either end of the 80,000-seat Camp Randall Stadium.

The stadium and DeLuca’s roots both stretch back to the same era. DeLuca wasn’t around in 1917, when the stadium was built, but around that time—in 1923, to be exact—his mentor Harry Steenbock showed that irradiation with ultraviolet light could add Vitamin D to milk and other foodstuffs. That led quickly to the control of rickets, a children’s bone disease.

It also led to one of the most successful technology transfer groups in American academia. Licensing Steenbock’s Vitamin D patent was the first order of business for the Wisconsin Alumni Research Foundation, or WARF, which debuted in 1925 with funding from alumni, not the school, but was chartered to manage the school’s patents and support future research. (The foundation went on to give its name to the world’s best-known blood thinner, warfarin, a rodenticide approved for medical use in 1954. Despite serious limitations, it’s still widely prescribed.)

“I was a grad student in Steenbock’s lab from 1951 to 1954,” DeLuca says, “and I’ve been working on Vitamin D since that time.”

That’s an understatement. DeLuca and his colleagues have made big contributions to modern medicine. They discovered the active form of Vitamin D and derivatives of it, leading to eight products and a half-billion dollars in royalties back to WARF—one alone, paricalcitol, sold as Zemplar by AbbVie, produces more than $30 million a year in royalties, according to WARF.

Nearly 80 percent of people on kidney dialysis now receive a synthetic Vitamin D hormone, WARF says. The damaged kidneys can no longer produce enough active Vitamin D, which has an effect on the body’s ability to absorb calcium and phosphate from the intestine. That causes all kinds of problems, including bone erosion: The body starts to eat its own bones, in effect, to get the calcium it needs.

DeLuca co-founded Bone Care International, which attracted a $719 million buyout in 2005 from Genzyme. The big biotech, now part of Sanofi, added Bone Care’s main product Hectorol—DeLuca says he was flattered when his colleagues named it in his honor—to its kidney-disease product line.

Vitamin D analogs already treat a range of kidney-disease side effects in the U.S., as well as osteoporosis in other countries, but those could just be scratching the surface. There is ongoing research into the role Vitamin D plays in neurodegeneration, immune disease, and cancer, although DeLuca is skeptical of its usefulness in cancer: “It’s very controversial and has not been proved at all.”

He also throws cold water on the possibility that Vitamin D could have a therapeutic effect on multiple sclerosis. It’s a prevalent theory, stemming from low incidence of the disease at or near the equator, where ultraviolet light is the most intense, but higher incidence in people living farther away from the equator. That theory doesn’t hold water. In fact, so far it seems to be the opposite: Vitamin D deficiency seems to inhibit the disease in mice (although DeLuca underscores that mice don’t get MS, so the “models” used in research are a rough equivalent).

But the research into the connection has led to another possibility: “It turns out to be a different UV band of light”—one that doesn’t trigger Vitamin D production in the body—“that appears to suppress MS,” DeLuca says. (Here’s the paper he and his colleagues published last year.) His campus lab—still around a dozen people and separate from Deltanoid—is pursuing that line: Could the anti-MS effect triggered by that narrower band within the UV spectrum be translated into a therapeutic? It’s a question that could take years to answer.

Nearer-term, DeLuca is looking for a new partner for Deltanoid. Founded more than a decade ago with licenses from WARF, Deltanoid once had hopes of bringing a new osteoporosis drug to market with its partner Pfizer. But in the wake of the 2009 Pfizer-Wyeth megamerger, Pfizer ended research in several areas, including bone health. “They abandoned that group, and we were one of the casualties,” DeLuca says.

Tiny Deltanoid instead wants to promote that same drug, DP001, for secondary hyperparathyroidism in patients on kidney dialysis. It’s a condition that DeLuca’s work has addressed before: Hectorol and Zemplar, for example. But he says Deltanoid has refined the Vitamin D analog, and it’s now a lower-dose option because it targets the thyroid more precisely and spares the intestine and bone. That could mean a lower cost of goods to make the product as well as a drug that doesn’t have the side effect of hypercalcemia, or dangerously raised levels of calcium, associated with Zemplar and other such treatments. (Those dangers are higher in the U.S. than other countries because our diets are already high in calcium, DeLuca says.)

The company just announced Phase 2b results from a 62-patient trial, and DeLuca presented the data at a medical meeting last week. The goal is to find a big partner to take the program into larger Phase 3 trials. “We believe it’s attractive enough that a company with resources can partner with us or finish the job,” DeLuca says. “We don’t want to raise funds to do it, but if that’s the only choice, we will.”

Ideally, however, DeLuca will hand DP001 to a bigger drug company and free up more time to pursue the ultraviolet light research. Pointing the way toward a new treatment for multiple sclerosis would be quite an achievement, one probably worth an honor or two—but it would have to be something other than his name above the entrance of the campus research complex where he still works.

That’s already been done. Last year, the school decided to dedicate its biosciences buildings to DeLuca, a rare honor in any setting, rarer still for someone not just alive but with no plans to retire anytime soon.