Llew Keltner flies about 600,000 miles a year. The CEO of Light Sciences Oncology insists he can’t imagine doing his job any other way. There are doctors in about 30 countries testing his company’s experimental drug/device combo treatment in clinical trials of cancer patients. He meets the physicians in person, twice a year, to talk about the product and learn how it’s being used. Then there are always meetings to talk about it with investors and potential partners. He visits the company office only once or twice a quarter, he says.
“How could I go into those meetings with investors if I didn’t do that?” Keltner says. “It’s invaluable experience.”
Still, I was able to book an hour this week to meet the highly-mobile Keltner at his company’s Bellevue, WA headquarters, a week after he raised $40.1 million in venture capital. Most of what’s been written about the company has focused on the “it-failed-to-go-public” angle, yet it turns out Light Sciences Oncology has a much more important news event coming up. After 13 years in business, it will find out in a few months whether the company’s light-infusion technique can actually help cancer patients live longer.
It’s been a long time coming for a company supported for years by Craig Watjen, the treasurer from the early days of Microsoft, and more recently, an array of venture capital firms that includes Essex Woodlands Health Ventures, Johnson & Johnson Development Corporation and Novo A/S. The market they are pursuing initially, liver cancer, affects an estimated 19,000 people in the U.S. each year, although the technology could be able to be applied to many more tumor types than that, Keltner says.
To understand why, some background is required. The company’s product, called Litx, is attempting to become the first treatment of its kind. The system works by using a light-emitting diode, guided by a biopsy needle, which doctors can thread inside a solid tumor with the help of an ultrasound or CT imaging machine. The patient is then injected with an inactive chemical drug called talaporfin sodium. Once the light is turned on, powered by cheap AAA batteries, it activates the drug to kill tumors within a limited wavelength, sparing nearby healthy tissue. The light stays on for almost three hours while the patient can watches TV or reads a magazine, and then goes home.
The company has passed some early clinical trials that show tumor shrinkage, yet has said little about it, Keltner says, because he doesn’t want to raise false hope among patients about a treatment that’s not yet available. Now, he feels he can “loosen up a bit,” because Litx has advanced to the final proving ground, a Phase III trial of liver cancer, which could provide evidence needed to bring the product to market.
The company began recruiting 200 patients for the test of LitX against liver cancer in November 2006. It chose that disease because liver tumors can easily be reached with the light device, and are extremely difficult to treat with anything else, like chemotherapy. Past studies suggest that patients with the cond, hepatocellular carcinoma, have about a five-month life expectancy. The study will compare those patients on Litx to ones randomly assigned to a treatment of the physician’s choice, and will compare overall survival time of the two groups. Results are expected early in 2009, Keltner says.
Since that date is fast -approaching, the company’s partners are looking to get a cut of the action before the price goes too high. Keltner says he’s confident he will sign a deal with a large pharmaceutical partner that can handle sales and marketing of the product, globally, for all solid tumor types, by the end of this year. Light Sciences Oncology has 36 employees, and doesn’t intend to build a sales force, he says. “We’re good at what we do, but we’re not a sales and marketing company,” he says. “We expect a substantial amount of money to come from our partnership.”
Since Light Sciences Oncology began its trial, another drug has emerged that prolongs lives for patients with liver tumors. Nexavar, a pill marketed by Emeryville, CA-based Onyx Pharmaceuticals (NASDAQ: ONXX) and Bayer, was approved by the FDA last year after it helped patients survive for a median time of 10.7 months, compared with 7.9 months for those on placebo. Light Sciences Oncology should still have room to compete, because unlike Onyx and Bayer’s, his company’s trial didn’t exclude patients who have more severe forms of cirrhosis, Keltner says. That means he could capture more of the market. Or, patients could take both treatments.
Another trial is running, of 450 patients with colorectal cancer that has spread to the liver, which should produce results by the end of 2009, Keltner says. Beyond that, the company is also developing its treatment for a non-cancer use: enlarged prostate, known as BPH.
Time was running out on my interview before Keltner could get to talk about all the other applications he sees of light-activated drugs, beyond cancer, so that will have to come another day. Always careful not to overpromise to the patients, he allowed himself a bullish comment when I asked him what he hopes the company will accomplish 10 years down the road.
“I really think 20 years from now we’ll look at light infusion technology as an incredibly interesting platform for a variety of human diseases,” Keltner says.