“There is only one FDA approved treatment for stroke,” says Arthur T. Taylor, the new president and CEO at PhotoThera Inc. (Carlsbad, CA), a company working on an infrared energy-based remedy. Genentech’s tPA, a drug approved in 1987, is a thrombolytic or ‘clot buster.’ It is an effective treatment–but only if administered within three hours after the stroke occurs. Because of the short treatment time window, less than 4% of stroke victims make it to the hospital in time,” Taylor told BioOptics World.
PhotoThera’s founder, Jackson Streeter M.D., said he had become intrigued by the therapeutic potential of infrared energy during his service as a Naval flight surgeon (see www.bioopticsworld.com/articles/340106). A November 2007 BusinessWeek article, “A Top Gun Takes Aim at Strokes,” explained that Streeter read about the technology upon which his company is based in “an obscure Hungarian medical journal” and “left his dream job as a fighter pilot to tackle the second leading cause of death” in 1997. Ischemic stroke, a condition that occurs when blood supply leading to the brain is blocked by a blood clot, affects more than 600,000 individuals each year in the U.S. alone, according to the American Heart Association. The result is brain damage, which can result in disabling injury or death. PhotoThera is pioneering the treatment of various diseases and health conditions, but its initial clinical focus is acute ischemic stroke (see www.bioopticsworld.com/articles/322985). While others have pursued the diagnosis or monitoring of stroke victims with photonics technology, PhotoThera’s is the first attempt at treatment through such means (see www.bioopticsworld.com/articles/343259/).
PhotoThera’s initial product, NeuroThera System (NTS), delivers noninvasive transcranial treatment for patients within 24 hours of stroke onset. NTS is an investigational device (that is, not yet approved for sale or distribution anywhere) that seeks to improve neurological outcomes. The system consists of a moveable console, a fiber optic cable, and a handpiece. A trained clinician uses the handpiece to direct the energy–a.k.a. transcranial laser therapy (TLT)–to 20 predetermined treatment sites on a patient’s scalp. The total procedure time is approximately two to three hours.
To date, PhotoThera has completed two clinical trials, NeuroThera Effectiveness and Safety Trial-1 (NEST-1) and NEST-2. Both studies were double blind, multicenter, randomized, sham-controlled evaluations. NEST-1, completed in 2006, was a 120-patient study that demonstrated initial safety and effectiveness of TLT when patients were treated within 24 hours of stroke onset. NEST-2, completed in 2008, was a 660-patient study that confirmed the safety profile found in NEST-1. Although NEST-2 did not achieve statistical significance on the primary endpoint, the trial did meet statistical significance for patients with moderate to moderately severe strokes.
This past February, University of California San Diego Professor of Neurosciences Justin Zivin–who served as Principal Investigator for NEST-2–presented the follow-up study results at the American Heart Association’s International Stroke Conference in San Diego, CA. Within the next 6 to 12 months, PhotoThera will launch NEST-3, a phase III international clinical trial with refined patient selection criteria. Zivin will co-chair the NEST-3 steering committee along with Professor Werner Hacke, Chairman of Neurology at the University of Heidelberg (Germany). According to Hacke, “TLT is one of the most promising new therapies that we’ve seen in a long time, especially as it may expand the treatment window for ischemic stroke to 24 hours.”
“The trial will need to show effectiveness in treating stroke patients that have suffered moderate to moderately severe strokes within 24 hours after the stroke,” Taylor explained. “Once the trial is complete, the company is required to submit a premarket approval (PMA) application to the Food and Drug Administration (FDA).” He expects FDA approval within two to four years afterward.
PhotoThera announced a $50 million Series D round of financing, led by leading global private equity firm Warburg Pincus, on April 30, at which point Taylor joined as the company’s new CEO. “The Series D funding is expected to finance the NEST-3 study,” Taylor said. –Barbara G. Goode