Allergy Therapeutics was forced to halt its Phase III trial of its Pollinex Quattro ragweed vaccine, but researchers for the company say the data still demonstrates its effectiveness. The study had been halted by the FDA due to an adverse event reported in an earlier trial. A patient reported neurological side effects including numbness and weakness.
But researchers were able to gather the responses of 381 patients who had received all four vaccinations called for in the study. And that data met the trial's primary endpoint, demonstrating a statistically significant response. The company now plans to go ahead and pursue an approval in Canada.
"This trial provides us with back to back proof of the safety and efficacy of Pollinex Quattro and is truly a scientific breakthrough for allergic patients," said CEO Keith Carter. "Having successfully completed the largest ever allergy vaccine study with our grass product we are pleased to be able to announce the successful completion of the second largest ever study. There is no other allergy vaccine in development or on the market with this depth of proof. We look forward to utilizing this data to gain a Canadian registration for Pollinex Quattro ragweed and in support of efforts to continue to make available to patients a much more convenient and rapid treatment for their pollen allergies."
- check out the Allergy Therapeutics release