Inflamax Research Inc., today announces the successful completion of patient enrollment in first US Phase II multi-center mEEC™ dose-ranging study with Grass MATAMPL immunotherapy for patients suffering from seasonal grass allergy (ClinicalTrials.gov NCT02582073) for Allergy Therapeutics
TORONTO, ON (PRWEB) MARCH 04, 2016
This is a landmark clinical study and is the first allergy immunotherapy study to utilize the mEEC™ in the United States. Inflamax’s unique and world leading technology was used to recruit and study patients in two separate locations in Neptune, New Jersey and Cincinnati, Ohio. The unique challenge in enrolling before the start of the tree season in the Northeast US was met with the deployment of Inflamax’s unique Online Central Recruiting Update Platform (OCRUP™). The data from this study will be instrumental in the launch of the Phase III program prior to end of 2016 utilizing Inflamax’s mEEC™ system in several locations within the United States. We also wish to thank the 20 investigator sites in Ohio, Kentucky, New Jersey, New York and Pennsylvania.
“Allergy trials rely on mother nature to produce consistent pollen concentrations to elicit adequate levels of symptoms in order to prove dose-response or efficacy. Unfortunately, climate change and variability in patient exposure in their everyday lives can lead to large variabilities and recruitment delays should the environment, weather, and other factors, not produce consistently. The novel mEEC™ technology enables study designs and endpoints to be infinitely more robust and allows for studying allergen-specific therapies, such as immunotherapy. The mEEC™ model is designed to provide consistent allergen exposure, over time, significantly reducing data variability and compliance compared to traditional field studies”, commented Dr. Anne Marie Salapatek, Chief Scientific Officer at Inflamax Research Inc.
Allergy Therapeutics® is a specialty pharmaceutical company focused upon the development of treatments for allergy. Allergy Therapeutics has an existing sales base of approximately £40 million per annum, an MHRA-approved manufacturing capability, as well as an established sales and marketing infrastructure in several major European markets. In addition, the Company has a number of novel compounds which have already undergone initial clinical evaluation and, once registered, could potentially revolutionize the treatment of allergy.
Inflamax Research is a global full-service, CRO specializing in allergy, respiratory, ocular and dermatology Phase I-IV research, led by world-known, key-opinion leaders. Inflamax has a strong scientific capability and publishes extensively in peer-reviewed journals. Inflamax’s Clinical Trial Management group has experience in conducting large multi-center trials in these, and other, therapeutic areas. Inflamax offers full-service including study design/concept development, medical writing, site management, monitoring, data management, statistics, and CSR development.