Associate

BioMS Medical Corp. said it received positive results from a Phase II trial of MBP8298 in a subgroup of multiple sclerosis patients and is planning to discuss a pivotal trial with regulatory authorities.

The four-year trial enrolled 32 patients with primary or secondary multiple sclerosis. However, a subset of 20 patients showed especially good results, the company said.

"We saw that there is a significant group of patients that have codes for HLA-DR2 or HLA-DR4 genes," BioMS President Kevin Giese said. "They respond very well to the drug."

BioMS, of Edmonton, Alberta, said that while the incidence of DR2 of DR4 genes is "relatively low" in the general population, in the estimated 2 million multiple sclerosis patients worldwide, about 75 percent of them have either the DR2 or DR4 gene. It is those patients who performed best in the trial.

The study was conducted in two phases: a two-year, double-blinded, placebo-controlled portion and a two-year, open-label phase. In the double-blinded phase, 20 of the 32 patients carried either the DR2 or DR4 gene - half of the 20 received MBP8289, the other half placebo. No patients receiving MBP8289 progressed, based on the expanded disability status scale, while six of 10 progressed in the placebo arm (p=0.0108).

Results after the open-label phase showed three of the 10 patients receiving the product had progressed. Results were valid for both primary and secondary progressive MS patients.

"You would assume that all patients not on the drug would have progressed," Giese told BioWorld Today.

Patients also had their anti-myelin basic protein (MBP) antibodies levels measured. Patients with the DR2/DR4 genes showed a significant and sustained reduction in antibodies, which was related to an absence of clinical progression (p=0.0108).

When looking at the trial through the eyes of the general population, half of the 32 patients received MBP8289 and half placebo. Five of the 16 patients receiving the drug progressed in terms of EDSS score, while nine of 16 progressed for the placebo group, a reduction in progression of 44 percent, although not statistically significant (p=0.29). The secondary endpoints of 22-meter timed walk and foot taps were not hit with statistical significance by either the general population or the DR2/DR4 subgroup, although both groups did score better than placebo, the company said.

The Phase II trial was conducted at the University of Alberta. The path ahead is not yet mapped, but BioMS plans to take care of that.

"We need a confirmatory pivotal trial, and that is what we are aiming for by the end of this year," Giese said. "We intend to speak to the regulators for the trial we have in mind."

The company would like to commercialize the product in Canada, the U.S. and the EU, but decisions on how that will be accomplished also will be topics of discussion with regulatory authorities.

MBP8298 is a synthetic peptide, Giese said. It was given intravenously twice a year in the trial. In MS patients, a relapse is associated with elevated levels of B-cell antibodies to the myelin basic protein. B-cell antibodies and T cells attack MBP amino acid positions 85 to 96, the company said. MBP8298, which contains MBP amino acids 85 to 96, is believed to clean up B-cell antibodies and down-regulate B-cell antibody production by inducing a positive immune response.

The company was founded in 1998 by Giese, along with his brother, Clifford. It was spun out of the University of Alberta specifically to advance the technology, although it also has an in-licensed technology called HYC750, which is designed to mobilize stem cells and neutrophils for treating cancer therapy side effects. It has been through one Phase I trial and another is expected in the next 12 months.

Publicly traded on the Toronto Stock Exchange, BioMS has raised C$40 million (US$29.1 million) to date - C$19 million through a private round and C$21 million publicly. Giese said the company has C$23 million in the bank, which should be sufficient for Canadian trials of MBP8289, although "we'd need additional funds for jurisdictions outside Canada," Giese said.

Those funds, he said, would either come from financings or partnerships. For now, however, BioMS and its 15 employees (plus another 10 at the university working on BioMS technology) are gunning for "getting [MBP8289] into a [pivotal] trial in the next year, and also getting a trial for HYC750 under way."

BioMS' stock (TSE:MS) rose C38 cents Friday, or 10.8 percent, to close at C$3.9.