Light Sciences Oncology Stumbles in Clinical Trial, Layoffs Loom

10/4/11Follow @xconomy

Light Sciences Oncology, the Bellevue, WA-based developer of an unusual drug/device combo treatment for cancer, has failed in a pivotal clinical trial and is preparing to make deep cuts, including layoffs, Xconomy has learned from sources familiar with the situation.

The privately-held company has raised well over $130 million since its founding in 1995, from a big-name group of investors that includes Essex Woodlands Health Ventures, Johnson & Johnson Development Corporation, Novo A/S, Scandinavian Life Science Venture, and the late Microsoft treasurer Craig Watjen—who put more than $50 million of his own money into the company before he died a year ago from cancer. Bob Littauer, the company’s chief financial officer, declined to respond to requests for comment about the outcome of the trials or any subsequent corporate decisions.

The technology at Light Sciences is unlike anything currently on the U.S. market to treat cancer. The company has spent all that time and money developing a drug/device combination therapy against solid tumors that aren’t treated well with conventional drugs that circulate through the body. The Light Sciences therapy uses a catheter with a light-emitting diode on the tip, which a physician sticks into a solid tumor. At the same time, the patient is injected with an inactive drug called talaporfin sodium (Aptocine). The doctor turns on the light, which activates the drug to kill tumors within the specific wavelength of light emitted by the LED. The light stays on for almost three hours while the patient watches TV or reads a magazine, and then goes home. The idea is to fight cancer without damaging the healthy tissue nearby.

The company has had to endure an almost agonizingly long wait to get an answer on whether its strategy really works. Light Sciences Oncology began a pivotal study of more than 200 patients with primary liver cancer back in June 2006, which sought to answer whether the new treatment could help patients live longer—the gold standard measurement of success with cancer drugs. Former CEO Llew Keltner told Xconomy in February 2010 that he expected results from the study in just a few months, saying “the proof for us will be in the pudding this year.” As far back as July 2008, he said that enrollment trends and patient life expectancy meant that clinical trial results could arrive as soon as early 2009.

The results didn’t arrive on schedule. By November 2010, Keltner left Light Sciences Oncology with no official explanation, and the company remained mum on the outcome of the trial. Light Sciences’ only public statement since came in May 2011, when experienced pharmaceutical executive Dennis Langer was named chairman of the company’s executive committee. At that time, the company said it expected to report data in the second half of 2011 on both of its pivotal studies.

The second study is designed to enroll more than 450 patients with cancers that originated somewhere else and have spread (metastasized) into the liver. That study is also designed to show whether the Light Sciences therapy helps patients live longer than they otherwise would on standard chemotherapy.

While the company hasn’t released any results to the scientific community, it did say on its clinicalstrials.gov posting in June that it had reached the final date for collecting data on the trial of 200 patients who cancer is primarily based in the liver. The 450-patient trial, of patients whose cancer had spread to the liver, is expected to yield its full set of data by September 2012, according to the posting on clinicaltrials.gov.

Light Sciences Oncology had 38 employees at the last reported count in March 2010.

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