Avenue

Labour of Love

A city tycoon eager to relieve his wife’s multiple sclerosis found hope in a university of Alberta lab. He added his business savvy and funding to the researchers’ skills — now the world is on the verge of getting a breakthrough drug.

words by Jeff Holubitsky
photography by Ian Sheh

• print
• email

Robin Giese woke her husband early one morning in 1996 with a few words that would change their lives forever.

“Cliff, I feel different,” she said.

“Are you sick again?” he asked. “No, my head has cleared up,” she said. “It doesn’t feel fuzzy.”

Like a miracle, the sleepy, almost semi-comatose perception of the world caused by multiple sclerosis was gone. It was also the first break in a dark cloud of anxiety caused by not knowing when the potentially fatal disease she’d had for nearly 20 years might strike another devastating blow to her body, shutting her away from others and eroding her ever-diminishing quality of life.

By that morning, Robin was relying on a wheelchair. She and her husband had once loved travelling to warm places together, but Cliff Giese believed those days were completely over. The heat of Hawaii and California and the hassles of flying only seemed to exhaust his ailing wife and exacerbate the growing paralysis caused by MS. extreme fatigue made it tough for her to be involved in activities. Cliff also worried that life had become so difficult for Robin that she had mentally withdrawn. “When a person gets a disease like that, it affects everybody,” he says. “It’s like dropping a rock in water. It affects . . . the children, the husband, the parents, the grandparents, the aunts, the uncles, the friends.”

But an experimental new drug then being developed at the university of Alberta stopped Robin’s disease dead in its tracks. It didn’t reverse the nerve damage already done she is unlikely to walk again — but she did not get worse. And after a few more doses, the treatment also lifted her out of her mental funk. “She was alive again,” Cliff remembers, looking lovingly at the woman he remembers as the prettiest student at NAIT, and who he married 40 years ago this month.

Despite physical limitations that still require the use of a wheelchair, today Robin is as normal as any mother and grandmother could be. She has a busy weekly schedule of exercising at the university, and hosts Wednesday lunches with her five grandchildren. She spends summer weekends at Pigeon Lake and winters at homes in Palm desert, Calif., and Hawaii. She and Cliff go out for dinner almost every night. No longer is she a prisoner of the disease.

And no longer does Cliff — who on the day that Robin rallied was a semi-retired Edmonton business tycoon who founded the Mr. Lube oil-change chain — rue the knowledge that regardless of the many millions of dollars he controlled, he was powerless to help his ailing wife. Soon afterwards, he matched his tough business sense to the dedication and perseverance of a couple of University of Alberta researchers in an 11-year drug-development project that now promises to bring relief to millions of MS sufferers worldwide, not to mention a landmark deal worth half a billion dollars to an Edmonton company.

* * *

When Robin was diagnosed with MS at the age of 27, shortly after the birth of their second child, Cliff embarked on an obsessive search for anything that might improve her life. But despite trying different drug therapies to relieve the symptoms, homeopathic prescriptions and acupuncture, after changing her diet and removing mercury fillings, Robin steadily grew worse. “It always seems that it is not fair, but nobody guaranteed that everything has to be fair,” Cliff says. “In our case, we didn’t give up. We said ‘okay. We’ve got it but what do we do?’ I think we did everything short of going to the Philippines and getting a witch doctor to pull out some chicken parts.”

Then a local neurosurgeon and his colleague injected a synthetic string of 17 amino acids called MBP8298 into Robin’s bloodstream. “That was the start of it,” Giese says. “She has since had 21 shots.”

Ironically, Robin’s treatment also launched a new phase of Cliff’s storied career, one in which he helped develop the drug now known generically as dirucotide. A successful businessman before, he’s poised to grab the brass ring yet again.

A NAIT business graduate, Cliff worked briefly as a stockbroker before coming up with the idea of an outlet that specialized in fast oil changes. When he sold the chain in 1987, he had just opened his 47th store. “I founded not only a business, but an industry,” says Cliff, who looks strong and healthy for 61, and whose only affectation of wealth seems to be fine-looking wristwatches.

After Mr. Lube, Cliff spent a decade developing numerous other investments along with his lawyer/MBA brother Kevin, including a directional oil drilling company. But in December 2007, he scored perhaps his biggest business coup; he convinced the international drug manufacturer Eli Lilly and company to sign a $497-million deal with the intent of bringing the drug that changed Robin’s life to more than a million secondary progressive MS patients worldwide. It is believed to be the single largest pharmaceutical licensing agreement in Canadian history.

Phase 2 and 3 trials of the drug, involving thousands of patients, are currently underway in Canada, the United States and Europe. Lilly has already advanced $97 million to the Edmonton-based company, called BioMS medical, that Cliff, his brother Kevin and his son Ryan started in partnership with the U of A to develop and market the drug.

The latest advance of $10 million came in mid-august, when an interim decision by the data safety monitoring board, an independent international body, determined that trials involving 200 patients taking the drug for two years were both safe and effective enough to continue to Phase 3. “By the end of 2009, we’ll know if the trials are successful and, at that point, the shareholders will be rewarded,” Cliff says, convinced that the drug will easily pass all remaining tests. After that, Eli Lilly will take over the marketing and distribution, while BioMS will receive a royalty for the duration of the patents. “If the drug is successful, the potential market (of MS patients) for BioMS to participate in is in excess of $10 billion annually,” says Cliff.

Yet, however successful the business, Cliff doesn’t believe the money should be making the headlines. He says the attention should be going to the two humble researchers, a medical doctor and a laboratory scientist, who are on the verge of proving to the world the power of quiet dedication.

* * *

Dr. Ken Warren, a neurologist with a special interest in MS, was recruited by the U of A and university Hospital in 1978, and opened the hospital’s multiple sclerosis clinic that year. His partner, Ingrid Catz, a research scientist with specialties in biochemistry and immunology, began working with Warren on the groundbreaking but painstakingly slow project in 1981.

Much research had already been done into helping patients who have relapsing-remitting MS, the form in which the disease usually starts. So Catz and Warren decided to help secondary progressive MS sufferers, like Robin, whose symptoms are more debilitating.

With relapsing-remitting MS, patients suffer periodic bouts, with symptoms that range from numbness to paralysis. Some patients appear to improve, until they are hit with another round of symptoms. As time goes on, the disease progresses to what’s called secondary progressive MS, which Robin developed. For people like her, things get steadily worse and there are no remissions between attacks. Forty to 45 per cent of the world’s 2.5 million MS patients suffer from the secondary progressive form. “We did not look a lot at relapsing patients because those guys have the attention of every other drug,” says Catz. Researchers working with those drugs count the number of relapses per year and if they are reduced in number then the therapy is considered successful, she says. “With progressive patients, it is a lot of work and we went for the underdog.”

MS symptoms crop up when, for some unknown reason, the body’s natural immune system runs amok and antibodies begin attacking the myelin sheath that surrounds nerve bundles; the sheath is comparable to plastic insulation that protects electrical wire. The attacks cause “holes” in the sheath, which then create “short-circuits” in the nerves. Impulses fail to travel from a to b, and various symptoms occur, depending on where the myelin is attacked. Warren and Catz went in search of exactly which antibody damaged the myelin. They believed that if they could slow or stop the body from making that antibody, they could put patients in remission and maybe avoid the side effects (like nerve damage) that occur when MS patients are treated by other drugs.

Proving this, however, was neither easy nor cheap. For 20 years, they conducted their research at the U of A on a shoestring budget, collecting and examining thousands of samples of spinal fluid from MS patients, as well as from people who didn’t have the disease. “Ken worked as a doctor in the day for a living and I worked in the big lab at the university Hospital because we had no money,” says Catz. Then, for several hours before and after their day jobs, as well as on weekends, they toiled at their own research.

Collecting samples demanded that they travel throughout Alberta to test MS patients in their homes. Spinal taps can cause severe headaches and the patients needed to be able to rest in bed after each sample was taken. The project would not have been successful without these patients’ co-operation, stresses Catz. Meanwhile, the process took a different toll on the researchers and their families.

“We wore out two or three cars,” Catz says. “Many miles, many blizzards, from Wainwright to north of Fort Assiniboine. It was tough slogging, I’ll tell you.”

Studying those samples, the researchers noticed that patients with active MS appeared to have more of one particular antibody in their spinal fluid. Their “eureka” moment came in 1986, when they isolated the antibody and the exact portion of the myelin basic protein to which it attached. However, the excitement of the discovery soon gave way to the realization that they were only at the beginning of a new long phase of research.

They needed to determine how much MBP8298 to give patients, how to administer the therapy and how to confirm that it worked. By the mid-1990s, they had become casual friends with Cliff, who dropped into their lab from time to time to inquire about their research, which he hoped might someday benefit Robin. During these chatty visits, they discovered their new friend’s generosity.

One morning he heard that the lab’s freezers had broken down; by that afternoon he had replaced them.

In 1993, Catz and Warren started their first tests of mbP8298 on five patients. Robin was invited to take part in 1996. While the treatment doesn’t work for everybody as certain genetic codes react better than others, BioMS believes that two-thirds to three-quarters of all MS patients have the genes required. None of the test patients got worse as a result of the treatment, says Catz. “And the beauty of this compound is it has zero side effects,” she says. “Other drugs can make patients sick.”

By 1999, Catz and Warren didn’t have enough money to continue their work, so they called Cliff at his Palm desert home for help. He and his brother supported the trials for a year. To raise money for further research, Cliff held a meeting with a group of investors, then flew off to Hawaii for a holiday. He was recalled to Edmonton a week later because cheques totalling $19 million had already accumulated on his desk.

BioMS struck a deal with the university (which is the biggest shareholder in the company) so Cliff could take the business opportunity to pharmaceutical companies. But he realized that unless BioMS conducted larger trials, the companies wouldn’t contribute as much as he thought the project was worth. BioMS got to work and, with approval for trials in Canada and Europe in hand, it took a load of documents a metre high to the U.S. food and drug administration in Washington, D.C., seeking approval for testing in the United States. Cliff says because the work of Warren and Catz was so thorough and well-documented, BioMS received approval in an unheard-of 30 days.

In seven years, BioMS has raised $180 million from investors. Eli Lilly has since added $97 million. If the final trials are positive, the payments from Eli Lilly will take the total investment to $500 million. “Not bad for a company with 29 employees,” Cliff says. But the truly positive news will be when MS patients like Robin are able to awaken without fear or confusion. “Our goal is to help all the Robins in the world,” Cliff says. There’s always a chance that the last trial results on the drug will disappoint, but Cliff doesn’t think that will happen. “I have inside information,” he says. “I wake up beside it every morning.”