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Two drugs for a hitherto fatal brain cancer are giving patients a new lease on life.

Posted on: 10/28/2004

Two drugs for a hitherto fatal brain cancer are giving patients a new lease on life.

Forbes Magazine
Taking on a Monster
Thursday October 28, 4:05 pm ET
By Mary Ellen Egan

David Herbert didn't think much about the slight headache he'd been having for a week and a half. It was November of 2000, and the then-58-year-old newly retired airline pilot was on jury duty. He attributed the headache to the stress of the trial. But the day the verdict was reached, Herbert noticed that he was having trouble reading the newspaper, and he felt like he might be coming down with the flu.

The next day his doctor told him to get a CAT scan immediately. There, on the right side of his brain, was a tumor the size of a tennis ball. Herbert had the tumor removed two days later and it was sent to the lab for biopsy. One month later Herbert was told to get his affairs in order. He had a glioblastoma multiforme and six months to live.

Three and a half years later Herbert is alive and tumor free. In June of 2001 Herbert received IL-13, one of two experimental drugs that destroy glioblastomas while leaving healthy brain cells intact. Though Herbert's survival is rare in its length, and it's too soon to know if these drugs are a cure, the compounds are at the very least slowing the progression of this monstrous disease. The biotech firms that make them, Neopharm in Lake Forest, Ill., and Xenova, in Slough, England, which makes a drug called Transmid, are moving as fast as they can into late-stage trials and hope to file for Food & Drug Administration approval in 2006 and 2007, respectively.

"It's exciting to have a race," says Dr. Tom Mikkelsen, codirector of the Hermelin Brain Tumor Center at the Henry Ford Hospital in Detroit. "I can count on one hand the number of drugs that have made it to (late-stage) trials in the last 20 years."

Each year 10,000 Americans are diagnosed with glioblastoma multiformes. The median survival time after detection is 12 months. The usual treatment is surgery, followed by radiation and anticancer chemicals. But unlike solid-mass tumors, glioblastomas have tiny tentacles that spread into the brain, making it impossible for a surgeon to remove every bit of the tumor. The tumor grows back, usually within six months, and is, for the most part, unresponsive to the drugs.

The most widely used drugs, accounting for a $500 million market, are Guilford Pharmaceuticals' Gliadel and Schering-Plough's Temodar. Gliadel extends the median survival by six weeks, and then only for patients hardy enough to have withstood a second surgery. Temodar is being used off-label to treat newly diagnosed patients, and extends the survival rate by eight weeks.

The preliminary results for IL-13 and Transmid are far more encouraging. Of the 44 patients with inoperable tumors who were treated with Transmid, 35% saw their tumors shrink in half or disappear; the median survival increased from 26 to 37 weeks. "There were a number of patients whose tumors completely disappeared. This is extremely unusual for this population," says David Oxlade, Xenova's chief executive.

The median survival rate for 97 patients on IL-13 almost doubled from 26 weeks to 44 weeks--and counting. Several patients have survived for more than three years, and the FDA has granted IL-13 rare fast-track designation to accelerate its approval. Neopharm and Xenova are currently enrolling at least 300 patients each in the U.S. and Europe for their late-stage trials.

Both IL-13 and Transmid take a Trojan horse approach. Brain tumor cells--especially glioblastoma cells--have large numbers of IL-13 receptors. (The IL stands for interleukin, a protein that instructs immune cells to divide or differentiate. The best known interleukin, IL-2, is used in treating AIDS.) Neopharm's compound docks in the IL-13 receptor site and introduces a toxic agent that interferes with protein production, causing the cell to die. The toxin is harmless to healthy brain cells, which lack IL-13 receptors.

Xenova's Transmid is a modified diphtheria toxin tied to transferrin--a plasma protein that transports iron through the blood. Transferrin receptors are particularly prevalent on rapidly dividing cells, such as tumor cells. The transferrin binds to its corresponding receptor, allowing the diphtheria toxin to enter into the cancer cell and kill it. Like IL-13, Transmid spares healthy cells.

Since both the IL-13 and Transmid molecules are too big to get into the brain via the bloodstream, doctors administer the drugs using two to four catheters inserted into the brain. The drugs are slowly infused into the tumor site during a three- to five-day hospital stay. Patients are awake and are able to walk around the hospital with the drug on a rolling IV stand. Side effects are minimal, and may include headache or dizziness.

Someday soon Herbert, the retired airline pilot, may no longer be such an exception to the rule. "I always said that I was going to buy myself a new Corvette when I turned 60, but for a while there it didn't look like I was going to make it," he says. Two years ago he picked up a metal-gray 'Vette in Kentucky and spent 14 days cruising across the country. Last month he drove from his hometown in northern California to San Diego to attend a reunion of his old pilot buddies.

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