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New drug may hold answer to cancer

Posted on: 08/25/2002

Calgary Herald
Sunday August 18, 2002 Page A11

New drug may hold answer to cancer

Clinical trials of Reolysin show promise David Heyman, Calgary Herald

The calls come once … twice… up to six times a day. Occasionally, people even walk into the renovation-filled Kensington offices with its fresh paint on the walls and rolled-up carpet in the dusty corners.

These callers know the Clary based company is testing a new cancer treatment called Reolysin, which shows breathtaking promise in clinical trials. But they don't have time to wait for Health Canada's approval.

They are dying of cancer, or know someone who is, and they're desperate for a cure. Most are amateur cancer experts, as up to date on the latest research as many researchers thanks to the Internet, and they're naturally pulled by hope toward the light of a cure. Their questions are the same: When will Reolysin be available and can they join the clinical trials?

The answer they get is simple, hard but frank: Reolysin (pronounced REE-oh-LYE-sin) is unproven and years away from doctors' offices in any event. And unless you meet certain strict requirements, you can't join the trials.

On caller recently phoned Oncolytic' CEO Brad Thompson in tears, accusing him of killing his cancer-stricken mother because he wouldn't allow her to have and injection. When recalling the conversation, he just shrugs because there was nothing he could do.

"If you have cancer today, the fact we've got this product doesn't mean very much," say Thompson. "We're working for people who don't have cancer yet."

It's not that he's unsympathetic. Thompson himself had a melanoma removed from his right thigh in 1999, an event that not only changed his life but also his career. Oncolytics phoned him looking for a CEO that same year. He was busy at the time as CEO of Synsorb, another Biotech company, and didn't often take such calls. But the idea of running a company whose purpose was to win the battle against the deadly disease held a special attraction.

"If I didn't have cancer, I doubt very much I'd be talking to you today," says Thompson, who quickly convinced Synsorb to buy his pursuer. Soon after, he left his post to concentrate on Oncolytics, and now claims he's the third-lowest-paid CEO of a publicly traded biotech company in Canada (though he won't reveal his salary).

Yet Thompson says he's willing to put off compensation because Reolysin has shown tremendous, perhaps unprecedented, promise in initial studies. Reolysin is composed of the reovirus, a naturally occurring virus to which most people will have been exposed sometime in their lives. Thanks to research headed by Patrick Lee at the University of Calgary, it has been shown to kill cancer cells that have an active Ras pathway while leaving normal cells healthy.

The Ras protein is a key regulator of cell growth. In some cancer cells it mutates, causing uncontrolled growth and eventually cancer. Up to two-thirds of cancers depend on mutated or active Ras pathways. That means Reolysin could theoretically be used to treat up to two thirds of all human cancers.

In research published last year in the Journal of the National Cancer Institute, 20 of 23 mice given a single reovirus injection had their tumours disappear completely.

Results of a Phase I human study – to determine only if Reolysin is toxic – showed patients suffered no serious side-effects regardless of the size of the dosage. They also saw that, when injected into living humans, it can kill many kind of cancer cells including breast, prostate, pancreas and brain tumours.

Oncolytics has now started a Phase II prostate cancer study, with 45 patients across Canada, along with the Phase I and II recurrent brain caner study. Results for the brain cancer study will be released no later than July 2003.

Still, much more work need to be done, and Health Canada approval is years away.

The only people with access to Reolysin so far are those included in the clinical trials, like Joan Lisoway, 57, the world's first brain cancer patient to get the drug. The mother of two was diagnosed with recurrent malignant glioma, one of the most aggressive and deadly brain cancers, in February 1999. She was initially told few patients in her condition live more than five years, with many dying much sooner. And if word weren't enough, the MRI image of her tumour explained it clearly.

"We didn't know anything about MRIs, but we could tell it wasn't good." Says Lisoway's husband, Jim.

Five operations later, surgical assaults on her tumour have slowed her voice along with her mental acuity but her eyes sparkle and her smile charms those around her, as does the delicate strength with which she copes with he condition.

"You just have to accept it." Says Joan Lisoway, whose daughter, Deborah, is studying cellular biology at the University of Calgary and did a recent paper on the reovirus.

"You're thankful for the time you're given."

Jim, as effervescent as his wife, says he's grateful for life's small mercies. After working at Park's Canada for 33 years, he took a buy- out package in 1998, just a few months before his wife's first seizure. Although he initially had other ideas for filling his days, he suddenly had plenty of time to take on his new role as caregiver.

"The good Lord looks after us sometimes, he says, adding the couple's Christian faith has only strengthened over the years.

Ironically, the don't go often to St. Stephen's Anglican Church where they were married 36 years ago because so many people want to help.

"If Joan was to walk in on a Sunday she'd be swamped by little old ladies who have known her for years," says Jim.

Instead, the couple prefers to spend their days more quietly in the backyard under the wooden gazebo reading the newspaper of gardening, although they venture out at least once a day for coffee or a meal.

They also try their best to share their optimism with others in the same situation. While waiting for their next appointment in the Tom Baker Cancer Centre, they often take a moment to cheer up others in the waiting room, telling them they're in good hands.

"These people are the best of the best," Jim says of the doctors in Calgary.

Since Joan had the three injections of Reolysin into her brain tumour June 27, hardly a week has done by without some kind of visit to a doctor for an examination and blood test.

Doctors are fascinated to know how the treatment – based on the action of the reovirus that seeks out and kills cancer cells while leaving healthy ones alone – will work in humans.

In Joan, it appears to be working well so far, but few details are available. Oncolytics is looking to have up to 37 other patients like her try the treatment.

The question of how well Reolysin will work is still open, but doctors involved in the trials are delighted to have a new tool in the fight, especially for brain cancer.

For the last 30 to 40 years, improvements in conventional treatments for brain cancer have utterly failed to extend patients' lives for very long, says Dr. Peter Forsyth, a Calgary neurosurgeon who is directing the clinical trials. Surgery, chemotherapy and radiation remain comparatively ineffective for brain cancer compared with diseases like leukemia, whose victims are usually cured.

"The reality is the majority of patients with glioblastoma die within a year," says Forsyth.

Not only are current treatments often unable to help, they can do tremendous damage by themselves.

Radiation, for example, is extremely toxic. "We do it because it's the best we have," says Forsyth. "You balance something that's incredibly toxic with something that's lethal."

Mark Hamilton, a neurosurgeon and head of pediatric neurosurgery at the Children's Hospital, is the man who actually inject the Reolysin into patients. He is virtually despondent with the range of options he has available, especially when it comes to children.

"If you put radiation into a child under the age of three, you're basically taking 30 IQ points away form them," he says. "It can be devastating."

None of the current treatments really get the entire tumour, he says.

Hamilton has even done hemispherectomies – removal of half of someone's brain – but the fast spreading disease still comes back.

"You can't take it all out," he says. "If you leave one cell, it comes back."

Reolysin is at the very least, a new idea. It gives people in Hamilton's position a chance to tell patients science is working on a solution.

"We're moving into a new box," he says.

With the reovirus, it seems to track down and kill cancer cells through the body in up to two-thirds of all cancers.

"It's extremely promising in test-tube animals," says Forsyth, who worked with Lee in the lab to develop Reolysin.

"We're able to cure the animals we treat and the animals remain healthy," says Forsyth. "To have something that works without a single side-effect is astonishing. On the other hand, it's easier to cure cancer in mice."

Other treatments have succeeded in mice, but failed in humans because they've been proven to be too harmful, too ineffective or otherwise useless, says Forsyth. Reolysin appears to work equally well, so far.

The bonus is, unlike other viruses being tested for the same purpose, such as herpes or the common cold, it doesn't have apparent side- effects and need not be altered before injection.

The reovirus, by contrast, is naturally harmless to humans. It was this quality which led to its original use at the University of Calgary, says Coffey. It can be studied by scientific novices in detail but if it is accidentally spilled or inhaled, on need only bring out a mop and pail rather than a biohazard suit. "It doesn't kill grad students," he quips.

Coffey, on of the three names on the original reovirus patent, is now employed by Oncolytics as vice president. His job is to talk with doctors to help them understand the product. A native of Medicine Hat, he moved to Calgary in 1989 and got his BSc in cell biology at the University of Calgary. He did his doctoral thesis on the reovirus.

Coffey and his colleagues are pushing for Reolysin's approval as hard as they can. In fact, they've chosen brain cancer for their Phase I and II trials because it usually kills quickly, so the effectiveness will be noticeable comparatively quickly. And, with its active Ras pathway, it's theoretically highly susceptible to Reolysin.

"We're doing it quickly. We all want it to go quicker," says Coffey. "The product's potential is so huge."

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