ProMetic says PBI-1402 for anemia still safe at higher dose

New York, Dec. 12 - ProMetic Life Sciences Inc. said that a phase 1 clinical trial of its PBI-1402 for anemia showed a good safety profile for the drug without any significant adverse effects even at a higher does.

"In addition to PBI-1402 continuing to display excellent reproducible safety, we are very pleased that we have now accumulated enough data to allow us to select a dose range for the oral administration of PBI-1402 in anemic patients," said Christopher Penney, vice-president of research and development and chief scientific officer for therapeutics, in a news release. "In fact, these latest results with PBI-1402 gave no indication that we are even approaching the maximum tolerated dose."

PBI-1402 was given to healthy volunteers at a higher dose than in the previous part of the phase 1 trial.

ProMetic said that research by Denis Claude Roy, hematologist and director of the cellular therapy laboratory at Hopital Maisonneuve-Rosemont and principal investigator of the latest study show PBI-1402 appears to operate by a different mechanism than the current drug of choice for the treatment of anemia, erythropoietin.

The results indicate PBI-1402 may be able to be used alone or with erythropoietin to treat anemia.

ProMetic, a Montreal-based biopharmaceutical company, plans to start a phase 2 clinical trial in cancer patients with anemia induced by chemotherapy treatment. Subject to regulatory approval, enrolment for the dose ranging study will begin in the first quarter of 2006.

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