Results of Phase III Trial Disappointing for MS Drug

07/28/2009

 From EdmontonJournal.com  
 
(Edmonton) - A new drug for treating multiple sclerosis developed by an Edmonton company has not done well in a key clinical trial.

BioMS Medical Corp.'s dirucotide did not significantly delay the progression of secondary progressive multiple sclerosis in a Phase III study, the company said Monday.

The two-year trial involving 612 patients in Canada and nine European countries also showed there were no statistically significant differences between the drug and placebo.

The disappointing results come after nine years of research and trials of dirucotide.

BioMS and par tner Eli Lilly said they would discontinue two other clinical trials of dirucotide and review the available data.

One trial is a follow-on to the one released Monday, while the other is a 510-patient U. S. Phase III that completed enrolment in August 2008.

The two companies signed one of the largest development deals in Canadian medical history last December when Eli Lilly agreed to pay$87 million up front, a further$410 million in development and sales milestones, and escalating royalties for worldwide rights to the drug.

A Phase II trial and long-term followup treatment of patients had shown dirucotide safely delayed median time to disease progression by five years.

"We are obviously very disappointed," BioMS CEO Kevin Giese said. "This represents a setback for everyone involved in the project over so many years, and some in a very personal way.

"We will be working closely with our clinical team to evaluate these data and the available data from (the other trials) to determine our next steps,"

BioMS is fortunate to have the resources to pursue whatever options emerge once they understand the results more fully, he said.

One of the noticeable differences in the results of the Phase II and Phase III studies was that the rate of disease progression in the placebo group was significantly less in the current trial.

It's something that's plagued similar MS trials, but researchers don't know why, Giese said.

Lilly Research Laboratories vice-president John Hayes said the study was well-designed and executed, "and we believe these data, while disappointing, are very instructive for us and for the larger MS community.

"We look forward to further conversations with BioMS Medical about this project."

Giese and brother Cliff formed the company as a University of Alberta spinoff after Cliff's wife Robin contracted the disease at 28. Cliff, who founded the Mr. Lube company, is chairman of the board.

"Robin has been on the drug for 12 years and it's totally changed her life," Kevin said after signing the deal with Eli Lilly last year.

As many as 2.5 million people worldwide, including about 75,000 in Canada, have MS. About 40 per cent of patients have the secondary progressive form of the disease.

There are limited treatment options for people with secondary progressive MS without relapses, and all have major side-effects.

It's been estimated U. S approval of safe new drug could lead to annual sales over $1 billion.

The trial results were released after markets closed Monday. BioMS shares closed at $2.80. There were as high as $4.10 in January.