BioMS founder's wife a participant in tests of medication seeking regulatory approval
Monday, April 22, 2002
Robin Giese is a walking advertisement for BioMS Medical Corp.
The wife of company chairman and founder Clifford Giese was diagnosed with multiple sclerosis in 1977 and received her first injection of the company's experimental drug in 1996.
She's been in remission ever since.
"This project is very dear to my heart," said Mr. Giese, who co-founded the Mr. Lube oil change franchise in Western Canada in the mid-1970s and has been on a quest to find a treatment for his wife ever since.
The Gieses were contacted several years ago by the University of Alberta, which was conducting research into a new MS drug called MBP 8298 and looking for money to continue clinical testing of the drug.
"We raised $19-million privately in 12 days from friends and relatives," he recalls. Last year, his newly launched BioMS licensed the technology from the university and went public.
While Mrs. Giese, who is 53, still uses a wheelchair, "she gets up in the morning and can function within her disability," her husband said. "She's not afraid now that when she gets a cold, her MS is going to get worse. It's given us peace of mind."
But Mrs. Giese's apparent improvement and testimonials from other patients who suffer from the chronic-progressive version of the central nervous system disease will not guarantee that the company's MBP drug will be cleared by regulators for general use until a rigorous clinical testing program has been completed. There are about 250,000 people in North America who suffer from the chronic-progressive version MS. A similar number of people suffer from relapsing-remitting MS, which attacks men and women between the ages of 20 and 40 with a wide variety of symptoms caused by an interrupted flow of nerve impulses along nerve fibres, but then goes into remission.
Since 1995, four medications have been approved for the treatment of relapsing-remitting MS, a $2.2-billion (U.S.) annual market, including the gold standard Avonex, which is sold by Biogen Inc.
For chronic-progressive MS, Immunex Inc. sells the only treatment, Novantrone.
The cause of MS remains a mystery. Research now suggests that genetic predisposition and environmental factors are at the root of the disease, resulting in an immune system attack against the myelin sheath that surrounds nerves in the body.
Two University of Alberta scientists, Kenneth Warren, a professor of medicine, and his research associate Ingrid Catz, discovered that chronic-progressive MS patients have higher levels of antibodies against "myelin basic protein" in the spinal fluid. They also found that immune system cells target a specific part of the protein: an amino acid sequence, or peptide, in MBP. By synthetically replicating that peptide, MBP 8298, and injecting it into patients, the researchers found that in certain circumstances, it lowered the level of antibodies and turned off the immune system attack.
The university has obtained 18 patents in 14 countries for the use of MBP 8298 to treat MS, with patents pending in 17 countries.
"Ken Warren's work on a synthetic form of myelin basic protein makes a lot of sense," said William McIlroy, national medical adviser for the Multiple Sclerosis Society of Canada.
But one biotech source, who reviewed the university's technology but decided against a licensing deal, isn't so sure.
"The fact that you can precipitate out [reduce] the antibody against myelin basic protein did not strike me as the cause of the disease but rather as one of the markers of the disease," he said.
In an initial test with 41 patients at the university that included Mrs. Giese, drug treatments put 61 per cent of participants into remission over a two-year period as measured by normal levels of MBP antibodies in the spinal fluid.
A 42-month Phase II trial with 32 patients was completed in May 2001 but only preliminary results have been released. They confirm the results of the Phase I trial, and some patients also demonstrated "clinical stabilization" in motor function tests.
Citing the company's arrangement with the university, BioMS president Kevin Giese, Clifford's brother, said complete results will be released by the third quarter this year.
In the meantime, BioMS is designing a pivotal final trial to begin in early 2003. Rather than license the drug to a pharmaceutical company, Kevin Giese said the company is leaning toward doing the big Phase III trial on its own in conjunction with a contract research organization.
BioMS has $25-million (Canadian) available for the phase III trial but
Kevin Giese figures the global trial could cost as much as $50-million.
© 2002 Bell Globemedia Interactive Inc.