Dad Pleading for Unapproved Cancer Drug Dies

Nov. 25, 2013— -- Nick Auden, the 41-year-old Denver man who had been pleading with drug companies for one last chance to beat his terminal cancer, has died.

"He never stopped fighting and never stopped believing he would conquer this absolutely horrendous disease," Auden's wife, Amy Auden, said in a statement following his death on Nov. 22 at home.

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Auden, a father of three, was admitted into a clinical trial to get what he called a "wonder drug" to treat his stage 4 melanoma over the summer, but hours later, he suffered a complication and was immediately disqualified from the trial. What's more, the drug companies that make the drug wouldn't allow him to take it on his own.

So after lying awake at 3 a.m., Amy started "Save Locky's Dad," an online petition and campaign named for Auden's oldest son, 7-year-old Locky. The goal was to get the companies to him the drug under "compassionate use" or "expanded access" programs, which allow still unapproved drugs to be used outside clinical trials.

They gathered more than 520,000 Change.org signatures, but the drug companies wouldn't budge. Two drug companies -- Merck and Bristol-Myers Squibb -- make versions of the so-called anti-PD-1 drug, which teaches the immune system to attack cancer, but they both declined to provide it to Auden outside a clinical trial. Bristol-Myers Squibb cited safety concerns, and Merck said it just didn't have enough of the drug to give it to him.

Auden's story started in March 2010, when he had a cancerous mole removed. Although it put him at risk for more skin cancer, he continued to live an active life, running, biking and hiking.

But in September 2011, Auden said his doctors sat him down and told him the cancer had returned and had spread throughout his body. The official diagnosis was stage 4 melanoma.

"Some people survive, 90-odd percent don't," he said. "There's no doubt that was tough news. I had trouble not being emotional about it every time I thought of the concept of not being there to watch the kids grow up."

Auden's wife was pregnant with the couple's third child when doctors told her husband that his median life expectancy was between six and nine months. He survived more than two years with the help of radiation and other experimental treatments, but time was running out.

When he learned about the anti-PD-1 drugs and their ability to treat melanoma, he got excited. Studies of Merck's version of the drug found that 38 percent of participants in a clinical trial for patients with melanoma saw tumors shrink. Of those who took the highest doses of the drug, 52 percent experienced tumor shrinkage.

Dr. Jedd Wolchok, an oncologist who has not met or treated Auden but has corresponded with him through email, told ABCNews.com that immune cells typically don't attack cancer in a meaningful way because of a kind of natural brake function called PD-1. But the new anti-PD-1 drugs cancel out that brake and allow the immune cells to attack the cancer.

Although there are currently no anti-PD-1 drugs in "compassionate use" trials -- trials for individuals who don't qualify for clinical trials but still want the drug -- Wolchok said there was chance the drug could offer Auden long-term benefits.