Accuray officials hope infusion of cash and positive results of clinical study will expand reach of its product

Success of CyberKnife in treating lung tumors has prompted a multi-center clinical study to generate peer review evidence to support earlier small scale studies.

At the same time, Accuray, owner of CyberKnife, has filed with the Security and Exchange Commission to take the company public.

CyberKnife is a robotic device that allows physicians to use radiosurgery on tumors anywhere in the body. The only one of its kind, the system tracks the patient movement in real-time during the procedure, enabling the delivery of precise, high dose radiation. Traditional systems have limited mobility and often require bracing the patient so they can’t move during delivery of radiation.

Even with FDA approval, Accuray needs more clinical data to convince physicians the system is effective long-term in the treatment of lung tumors.

To that end, the company has launched a clinical study at 10 medical centers across the country, including Stanford University and Community Medical Center in Fresno, said Dr. Omar Dawood, senior manager clinical programs at Accuray.

The goal of this study is to assess short and long-term outcomes after CyberKnife treatment for early stage non-small cell lung cancer in patients who are medically inoperable.

The study will evaluate CyberKnife’s impact on clinical response, local control of the disease, progression-free survival, overall survival, dyspnea scores, and quality of life, said Dr. Douglas Wong, radiation oncologist who is conducting the study at Community Medical Center in Fresno.

“Many physicians are still unaware of CyberKnife’s broad clinical applications,” said Dr. Wong.
The study was launched in August, and all the centers are expected to start taking patients by January. Medical centers are expected to recruit a total of 150 patients into the study this year, and follow the patients for about five years to monitor their clinical outcomes.

“We have 21 patients so far,” said Dr. Dawood. “We expect to get about 10 patients per month in the study.”

More than 20,000 people worldwide have been treated with CyberKnife since it was introduced to the market about eight years ago. And about half of the patients treated in the United States were treated for tumors outside of the brain, according to Accuray.

In November, Sunnyvale, Calif.-based Accuray filed with the SEC for its initial public offering sometime this year. The company has more than 25 million shares to sell. Under SEC rules, the company is in a quiet period, which means company officials can’t discuss company business other than basic clinical information.

Like many start-ups, the company continues to operate with a financial loss. As of year ended June 30, net loss was $33.7 million, on revenues of $52.9 million, compared with a loss of $25.7 million on revenues of $22.4 million during the same period a year earlier, according to SEC fillings.

The rate of cancer worldwide is expected to grow over the years, creating a large market for CyberKnife. There are an estimated 24.6 million people living with cancer worldwide, and about 10.9 million new cases of cancer are expected every year, according to the World Health Organization.

In the United States, an estimated 564,000 people died from cancer, and 1.4 million new cases were diagnosed, according to the American Cancer Society. And the National Institutes of Health estimates more than $74 billion was spent on cancer care in the United States during 2005.

In 1990, CyberKnife inventor John Adler, started Accuray with a team from Stanford and private financing. The system received its first FDA approval in 1999 to treat head, neck and upper spinal tumors. As of September, 83 CyberKnife systems had been installed, and 78 were pending. The system costs about $4 million.

Troy May is the editor of BAON. You can reach him at tmay@baoncologynews.com.

—By Troy May

Posted on January 19, 2007 02:58 PM