Written by: Kristen Consillio, Star Advertiser, November 23, 2015 @ 1:30am

The University of Hawaii Cancer Center is a step closer to getting federal approval for a new bladder cancer drug.

The drug, an interleukin 15 superagonist complex combined with Bacillus Calmette-Guerin, or BCG, currently in clinical trials, is expected to be more effective for patients with nonmuscle invasive bladder cancer, the most common type of the disease.

“The last time the (U.S. Food and Drug Administration) approved a drug for bladder cancer was almost two decades ago. Bladder cancer treatment hasn’t advanced very much,” said Dr. Charles Rosser, director of the UH Cancer Center’s Clinical Trials Office, in a news release. “BCG has been the main drug used to treat the disease since the ’80s. The science field has changed so much since then. We may finally be able to move the field forward and get better drugs to patients.”

Bladder cancer, which has a more than 50 percent recurrence rate, is the fourth most common cancer among men in Hawaii. On average about 147 men and 45 women in Hawaii are diagnosed with bladder cancer every year.

Phase I of the study with about nine participants was completed in the summer. At least 20 percent of the participants were expected to have a recurrence of bladder cancer by now, but so far the disease hasn’t returned, UH officials said.

The FDA approved Phase II of the study, as did the Institutional Review Board, a committee established to review and approve research involving humans. The first patient for Phase II was enrolled Oct. 15. The study will have about 124 participants, mostly from Hawaii. If the second phase is successful in showing improved outcomes and limited toxicity, UH researchers anticipate starting the final phase of clinical trials in 2017.

“At least five other academic centers on the mainland are opening this clinical trial because of encouraging preclinical studies in addition to the Phase I clinical trial results,” Rosser added. “It is exciting because it started here in Hawaii, and other patients across the country, even across the world, may see positive results as well.”

Clark Morgan, a Kailua resident and Phase I clinical trial participant, said he didn’t hesitate to participate in the clinical trial since the drug has had positive results in the lab. Patients interested in participating in the clinical trials must be referred by their primary care physicians and can call the Cancer Center at 564-5995.

“I thought, well, I have bladder cancer, my wife had breast cancer about seven years ago, so she said we have to do what we can,” he said. “I thought it was convenient that I could stay in Hawaii to get this treatment. I don’t know if I would have gone if it was on the mainland.”

Nationally there are 74,000 new cases of bladder cancer — ranked in the top five cancers for men in the U.S. — every year and an estimated 16,000 deaths, according to the National Cancer Institute.

The UH researchers’ goal is to get the drug FDA-approved and developed by Florida-based Altor BioScience Corp. in about four years. The studies are being funded by Altor and the Hawaii Cancer Consortium, comprised of the UH Cancer Center, Queen’s Medical Center, Kuakini Medical Center, Hawaii Pacific Health and UH John A. Burns School of Medicine.