Senior Staff Writer

Following last week's American Society of Clinical Oncology meeting, at which it learned of toxicities in its Phase II GD0039 renal cancer trials, GlycoDesign Inc. said it is shelving the product.

"In the North American and [French] trials for renal cancer, this past week at ASCO we found out that we are seeing toxicity," said Sheri Zernentsch, investor relations manager at GlycoDesign. "Part of that toxicity was confusion and severe fatigue. Both ethically and as a drug development company, management had to decide, Do we go further or do we stop enrollment now?'"

The Toronto-based company decided to stop enrollment. After seeing adverse events in about 10 percent of patients in the Phase II trials, as well as seeing neurocognitive defects in others, a successful Phase III trial, in which neurocognitive defects would be measured, seemed unlikely, Zernentsch said.

Thirty-five patients have been enrolled in the trial, with five currently in the eight-week regimen. For those still receiving the drug, the option for further treatment is there.

"If [the patients] decide to continue, they can," Zernentsch said. "But we are not enrolling anyone else."

GlycoDesign was conducting preclinical work with GD0039 for combination therapy with approved drugs, and that work has been stopped, too. Although the company may revisit the compound in cancer "down the road," Zernentsch said, GlycoDesign is "in a position that, should we look at the drug in another area, we would have to look at that very closely."

GD0039 is a carbohydrate-processing inhibitor - a small-molecule, orally administered inhibitor of the Golgi enzyme amannosidase II. In cancer, carbohydrate-processing inhibitors are designed to inhibit enzymes responsible for the synthesis of abnormal carbohydrates on cancer cells.

With the GD0039 decision behind it, GlycoDesign is focusing its efforts on other programs. It has GH9001, an antithrombotic designed to be more effective than low-molecular-weight heparin in treating diseases and conditions where that agent has limited efficacy. The product is in Phase I studies in the UK and is partnered with Leo Pharmaceutical Products Ltd., of Denmark. Possible indications are the prevention of deep-vein thrombosis, treatment of deep-vein thrombosis and prevention of pulmonary embolism.

"We should have results from that study at about the end of July," Zernentsch said. GlycoDesign is looking to partner GH9001 with a pharmaceutical company for Phase II and Phase III trials. The agreement with Leo ends after Phase I work, although Leo has an option to be part of further development.

Its Core 2 enzyme inhibitors program for the treatment of inflammatory diseases is partnered with Seikagaku Corp., of Tokyo. The companies' work is still in the discovery and animal stage. There are three compounds being evaluated, and Seikagaku has an option to develop one of the compounds.

Although the GH9001 and Core 2 inhibitor programs will receive most of GlycoDesign's attention now, it has other early stage programs in the cardiovascular or thrombosis area and also leukemia and stem cell therapy.

The company is at the proverbial crossroads.

"Our new President and CEO [Michael Thomas] started on April 1," Zernentsch said. "One of his promises was, over the next 90 days, to restructure the company to have a very focused scientific program. And this is one step in doing that. At the end of the three months, we will have a good idea of which programs we will accelerate very quickly and which ones will be the second wave."

GlycoDesign's stock (TSX:GD) on the Toronto Stock Exchange fell C83 cents Friday, or 28.8 percent, to close at C$2.05.