he thinks it is going to turn out. Patients in the study had CT imaging scans to look at the bulk of their tumors, and the company has been able to see tumor shrinkage on some of them without violating the blind. That can be a leading indicator, but isn’t always predictive of a drug that’s helping people live longer.
Keltner, who keeps an insanely busy schedule that keeps him flying 600,000 miles a year, makes a point of visiting the clinical trial physicians all over the world twice a year. He says he’s gotten to know them this way, but he’s careful to help support them, without asking how their patients are doing, which might inject bias into the study. He would allow me this much color from what he sees on his travels:
“We have several high recruiting sites, and they’ve been scrambling and fighting to get more patients in before we shut down the queue,” Keltner says. There has also been pressure to allow patients in the control group to “cross over” to get the Light Sciences drug, a practice that is sometimes allowed for terminal patients in cancer trials, although this study was not designed to allow for that, Keltner says.
The second critical trial for Light Sciences involves 450 patients with colorectal cancer that has spread to the liver, and in some cases, other parts of the body like the lungs. Patients were randomly assigned to get the Light Sciences treatment in addition to chemotherapy that circulates throughout the body, or just the standard chemotherapy alone. That trial just finished enrolling its last patients, which Light Sciences announced last week.
The colorectal cancer study is asking a different question—whether the Light Sciences therapy can prevent the cancer from spreading for a longer period of time. That primary study goal, called progression-free survival, can yield an answer much more quickly than a study that has to follow people until they die. So that trial could also provide an answer around the same time as the other one this summer, Keltner says.
Most potential partners have basically said they prefer to stay in a wait-and-see mode to look at these results before they write a big check to help market the product, Keltner says. If the data turns up positive, a few things will happen: Light Sciences will issue a press release, prepare to re-file its IPO prospectus immediately, start partnership talks, prepare a manuscript for submission to a peer-reviewed medical journal, and mobilize its data for an application to the FDA.
If the data turns up negative, the company still has some fallback options with light-activated therapies for enlarged prostate (benign prostatic hyperplasia), and dermatology uses. So while it would be devastating, it may not be the end of the company if the cancer trials fail. Keltner, for one, is really getting tired of waiting for the answer to that question himself.
“It’s frustrating,” Keltner says. “We’ve been at it a long time. And we’ve made huge progress.”
