ICOS impotency drug passes last-stage trials

Herald staff

Clinical study results presented in Italy Tuesday continued to provide good news for Bothell’s ICOS Corp.

Cialis, a drug being developed by a partnership between ICOS and Eli Lilly and Co. to help men with erectile dysfunction, was effective in 81 percent of patients, company officials said.

"With each new data analysis, we continue to see consistent and robust scientific evidence that Cialis has an attractive profile," said Dr. Charles Beasley, medical director of Eli Lilly. "The many findings from these Phase III analyses suggest Cialis has the potential to be a valuable treatment for a large number of men who have ED, regardless of severity."

The results of the late-stage clinical trials were presented Tuesday at the Fourth Congress of the European Society for Sexual and Impotence Research in Rome.

The study involved 972 men, including 261 given a placebo.

Among the key findings reported by ICOS:

Absorbtion of the drug isn’t affected by age, food intake, kidney function and liver function, meaning prescribing the right dosage for people should be straightforward.

"These findings suggest that dosing for Cialis should be simple and uncomplicated, which is important from a health care professional standpoint," said Harmut Porst, associate professor of the urological department of the medical university in Bonn, Germany, and secretary general of the society. "From a patient’s point of view, it is the absence of food effect that I find most interesting. These data suggest that a man can have a normal, romantic dinner with his partner without diminishing the effect of Cialis."

Men with diabetes, typically difficult to treat, had improved erections in 76 percent of the cases

The drug works for up to 24 hours and as early as 16 minutes after ingestion. Most men responded within a half-hour.

"This period of responsiveness may be an important attribute for emerging ED (erectile dysfunction) treatments, as it may enable a man and his partner to have sex whenever they choose within a 24-hour period," Porst said.

The studies reported that Cialis was well tolerated, with generally mild to moderate side effects that diminished in frequency with continued treatment. The most commonly reported side effects throughout the Phase III trials were headache, upset stomach, backache, muscle aches, flushing and nasal congestion.

The drug has yet to win approval from U.S. or foreign regulators. It’s currently under review for marketing approval by the European Agency for the Evaluation of Medicinal Products and the U.S. Food and Drug Administration.

If approved, it would be the first drug to reach the market from the Bothell biotechnology company.