ImmuLogic Pharmaceutical Corp. said Monday that results ofits Phase II Allervax Cat trial showed a statistically significantdose response. Results were reported at the AmericanAcademy of Allergy and Immunology meeting in Anaheim,Calif.
The double-blind, placebo-controlled trial studied 91 patientsin a controlled-antigen environment before and after receivingthe Allervax Cat therapeutic. Patients assessed their clinicalimprovement by rating themselves on 10 allergic symptoms.
One placebo group and three active groups were studied, withpatients receiving either placebo, 7.5 ug, 75 ug or 750 ug of thetherapeutic weekly for four weeks.
A statistically significant decrease in symptoms from baselinewas demonstrated when comparing the 75 ug or 750 ug withplacebo. T cell analyses did not reveal statistically significantchanges after six weeks.
"The results of this trial support our approach that thesubcutaneous administration of portions of a specific antigencan successfully reduce patients' immune-related symptoms,"said Malcolm Gefter, ImmuLogic's chairman and chief scientist."The statistically significant dose response observed in the trialgives us further confidence to proceed with the clinicaldevelopment of both Allervax Cat as well as AllervaxRagweed," he said.
Richard Bagley, ImmuLogic's president and chief executiveofficer, said the Phase II trial gives the initial informationneeded to design an effective Phase III trial to register thetherapeutic.
ImmuLogic (NASDAQ:IMUL) of Waltham, Mass., is in the middleof a second Phase II trial in which 72 patients are beingchallenged with the cat allergen administered directly into thebronchial airway. Other Phase I/II trials, conducted by MarionMerrell Dow Inc., are expected to begin this spring. If resultsare consistent with this trial, worldwide Phase III trials wouldbe expected to begin in early 1995, the company said.
In a separate matter, ImmuLogic said it has received a $5million license payment from Merrell Dow. An agreementsigned in 1992 relating to the joint development andcommercialization of the Allervax family of therapeuticsprovides for license and milestone payments of up to $42million. ImmuLogic has received $18 million so far.
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.