All in The Family

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By Kristine Archer

For Kevin Giese, president and CEO of Edmonton, Alta.-based BioMS Medical Corp., being a success isn’t just business — it’s personal.

After all, the company he has overseen since its inception was born largely out of a desire to help his sister-in-law overcome a crippling illness.

Family Ties
“My brother Cliff (co-founder and chairman of BioMS), his wife Robin has secondary progressive multiple sclerosis (MS),” Giese explains. BioMS began to take shape after Robin participated in a study at the University of Alberta (U of A) (Edmonton, AB), involving a synthetic peptide called MBP8298.

“There were a number of Phase I clinical trials conducted at the University of Alberta, and she happened to be one of those patients,” he says. “She’s been on this drug for nine years now, and has responded extremely well to it. Anecdotally, in her case, it has arrested the progression of the disease.”

Having seen the treatment’s potential firsthand, the Giese brothers were intrigued when the university came calling.

“They actually approached my brother and myself, recognizing that we had public company experience, (as well as) experience in building teams and raising finance,” Giese explains.

Now BioMS’s lead drug candidate, MBP8298 is comprised of 17 amino acids. It is designed to mimic a portion of human myelin basic protein that is the dominant site of autoimmune attack in MS patients with HLA haplotypes DR-2 or DR-4. MBP8298’s apparent mechanism of action is the induction or restoration of immunological tolerance with respect to ongoing immune attack at this molecular site. A Phase II clinical trial has shown a statistically significant clinical benefit of MBP8298 in patients with these HLA haplotypes.

Given the limited treatment options currently open to MS patients, taking a chance on a drug like MBP8298 could pay huge dividends, according to Giese.

“Success with MS drugs can be phenomenally big in terms of a public company,” he says. “Existing drugs in the market right now are doing about $4 billion US in sales on an annual basis, and they are in the relapsing/remitting form of the disease. We, in fact, are in clinical trials in secondary progressive — the only Phase III clinical trial in the world.

“(There are) very limited drugs out there for secondary progressive MS and there are about the same number of patients that have that form of the disease,” Giese continues. “So you have about at least a $4 billion US market potential in that area, and it’s basically wide open. So as a public company, in a couple of years’ time — if all things work out — you should be able to see a great boost.”

Growing Pains
While Giese realized the possibilities surrounding MBP8298, there were still challenges to overcome.

“When we brought this technology out of the university, it was sort of at an interim stage,” he explains. “Phase II was just completing and the technology needed a lot of manufacturing and toxicology work in order to prepare it for the next stage of clinical trials, so we were in a bit of a catch-up mode. That made it a challenge in terms of raising money, particularly with institutional players.”

Raising capital is always an issue for emerging biotech companies, even in the most fertile business environment. BioMS chose to go public to raise that much needed funding, and found that their environment both helped them and hurt them.

“It was almost completely in Edmonton,” Giese says of the funds raised during the initial public offering. “It was almost all (people) that knew Robin personally (and knew) what the drug had done for her. (It was) an unsolicited response in many cases, from people we didn’t even know, who heard about what we were . . . it was really exciting.
“In terms of getting investor support at an early stage, because of the local nature of this technology, it really was a good response.”

The disadvantage of operating out of a relatively small biotech market, “has been getting exposure in the big public markets in Toronto and Montreal, because we were this Alberta-based technology,” Giese says. “(It took) a lot of extra effort to tell our story — a lot of time on the plane to do that, and time away from our respective families.”

A Different World
This is just another in a series of uncommon turns Giese’s career has taken. He practiced law from 1984 to 1986, before becoming vice-president of franchise development with Mr. Lube Canada Inc. (Mississauga, ON), another business founded by his brother. Giese also served as president of Mr. Lube U.S. and held senior positions with NQL Drilling Tools (Nisku, AB) throughout the mid-1990s — not exactly the roadmap to a successful biotech career.

His lack of science background could be perceived as a disadvantage, but Giese says that his fresh perspective gave BioMS a competitive edge compared to traditional biotech start-ups.

“I think it was an advantage because we could approach it from a business perspective. I think a lot of universities have had negative experiences over the years with backing a researcher . . . (who) is more focused on primary research and not necessarily delivering a drug at the end of the day,” Giese explains. “In terms of our individual backgrounds, I think we bring a good business balance to what is otherwise a clinical team.”

Giese adds that while the service bays and drilling operations have been replaced by laboratories and clinical trials, commonalities exist across all the businesses he has been involved with.

“The development of your company is focused around milestones,” he says. “As you meet a milestone the value of your project and your company typically tends to increase.

“For example,” Giese continues, “if you’re going to do a drilling program and your first round of drilling (is) successful, typically that company is worth more money. (Then) you raise more money and you go on to the next stage of drilling, and eventually the full development of a field.

“You can liken it to biotech — it’s similar in that way. Your Phase I, Phase II and Phase III development programs come out, separated in time. If those are successful, you increase the value and the ability to raise money and move the project along.”

Giese acknowledges, however, that one of the challenges of the biotech industry is to accommodate for factors over which a traditional businessman has no control.

“One of the things that’s unique about the biotech world is the necessity to gain the acceptance of outside stakeholders, over which you have very little, limited influence,” he says. “For example, the medical community and the regulatory bodies all have a great say in the development of how your project moves along.”

One Day at a Time
Despite ongoing challenges and a hectic schedule, Giese says he has no trouble finding reasons to forge ahead, be they business or personal.

“Just seeing what it does for the MS patients is a great motivation,” he says. “(Robin’s) story is really mirrored by everybody else’s . . . they all talk about it changing their lives.”

And while some may balk at the idea of working with family, Giese says that, in his case, he wouldn’t have it any other way.

“I think in our particular circumstance it makes things easier,” he explains. “We have a very good working relationship that we’ve developed over the years and we really do work together as a close team.”

With his eyes on adding at least one more clinical stage technology to the BioMS pipeline — which includes the company’s HYC750 technology, designed to mobilize stem cells and generate neutrophils — Giese is looking forward to a fast-approaching future in which the full potential of MBP8298 can be realized.

“When you look at it from my investors’ perspective, we would expect that we’re going to see some data in just over two years’ time out of this Phase III clinical trial. Our interim data should be coming out in that time period, and that’s not very long to wait.

“It’s been great,” Giese continues. “All projects have their tougher days and their easier days. No matter what happens for us, we know in the back of our minds that this is a great drug and we really do believe in it.”