Gets green light for Phase III trials
Tuesday, June 8, 2004
Globe and Mail
BioMS Medical Corp. of Edmonton cleared a key hurdle yesterday in the quest to market its flagship multiple sclerosis drug, and nobody was more thrilled than chairman Clifford Giese -- who founded the company to help his ailing wife.
"I keep telling people I'm dealing on inside information because I know it works," he said after Health Canada gave the go-ahead to BioMS to launch pivotal Phase III clinical trials of the drug, MBP8298, in patients with secondary progressive MS -- a debilitating form of the disease that has few treatment options.
Mr. Giese, who founded the Mr. Lube chain of auto service centres in Western Canada in the 1970s, said his 55-year-old wife Robin's symptoms have improved markedly since she went on the drug about seven years ago.
Although still confined to a wheelchair, she now has more energy, can travel extensively and enjoys playing with her grandchildren.
"Let me go back seven years. She was completely fatigued and had a hard time participating in life in general.
"The disease was taking her down," he said.
Judy Smith's improvement has been just as dramatic.
She used to rely on a walker to get around and needed a two-hour nap every afternoon just to get through the day.
"I received my first injection in 2000. They chose me because I was rapidly deteriorating," the 62-year-old said.
Now, she walks several kilometres using only a cane and regularly meets tenants in her job as a property manager.
"The walker is in storage. I tell you, I am starting my life over," said the resident of Barrhead, Alta., who was diagnosed with MS in 1978. "I haven't experienced this energy level in 30 years."
Shares of BioMS gained 26 cents or 7.7 per cent to close at $3.65 on the Toronto Stock Exchange yesterday on news that the drug is heading for Phase III trials, a milestone the vast majority of drugs never reach.
The Gieses were contacted several years ago by the University of Alberta, which was looking for funding to continue clinical testing of the drug.
Mr. Giese and his brother Kevin, BioMS's chief executive officer, worked their business and personal contacts to raise $19-million in less than two weeks.
About 250,000 people in North America suffer from the secondary progressive form of MS, which accounts for nearly half of all MS patients.
MS is a degenerative disease of the central nervous system characterized by symptoms including paralysis, blindness and cognitive impairment.
But making MBP8298 widely available could take several years and many millions of additional dollars, assuming the Phase III -- or final -- clinical trials produce significant results.
The double-blind, placebo-controlled study will include up to 553 patients -- including Ms. Giese and Ms. Smith -- who will receive injections every six month for two years.
BioMS has enough money to cover the Canadian portion of the trials, which will cost roughly $23-million. But it plans to raise another $10-million in the next 12 months to expand the study internationally, Kevin Giese said.
At some point during the trials, BioMS may raise money by licensing the drug to a pharmaceutical company, he said.
But the longer BioMS conducts trials on its own, the more potential upside there is for its shareholders, he added.
"We've put together a management team that's really experienced in developing clinical trials and moving them through, so we're comfortable doing that."
He expects trials to finish toward the end of 2007 and, if all goes as planned, the earliest that the drug could come to market would be 2008.
"It's fantastic," Clifford Giese said. "What [Health Canada's decision]
gives us is validation that we really have something."
Copyright © 2004, Bell Globemedia Publishing Inc.