Inflamax Research Inc. today announced that it has been selected by Allergy Therapeutics (UK) Ltd. (ATL) (AGY:LSE), as the CRO to conduct ATL’s pivotal Phase III study for Grass MATAMPL product for US-FDA registration.
Toronto, ON (PRWEB) April 09, 2013
The study will involve the location of mobile EEC at centers in three metropolitan areas in the US Midwest, US North East and in Canada, with several investigative sites at each node contributing subjects to the study. The screening and dosing will take place at the investigator site and the subject will be sent to the mobile EEC, located close to the investigator site, for EEC related activities. Inflamax will operate the mEEC™ and manage the study as a full service offering including site management, monitoring, data management, statistics and medical writing. Inflamax Research will employ its innovative electronic diary system (ePDAT™) and Online Recruiting Update Platform and subject referral system (OCRUP™) in the study.
This study which involves over 600 subjects and with plans for a one year follow on study will not commence until ATL has finalized partnership discussions.
“We selected Inflamax because of their unique ability to conduct high quality multicenter studies utilizing the EEC technology. I particularly like the ability to have key opinion leaders in the US able to participate in our EEC clinical trials, which has not been possible with fixed single center EEC studies up to now. We also like the advanced technology that Inflamax employs in the study conduct such as ePDAT and OCRUP™” says Manuel Llobet, ATL’s CEO.
“We are pleased to have been chosen by ATL to conduct this important study of their novel ultrashort allergy vaccine using our mobile EEC system. Our leading edge technologies such as ePDAT™ and OCRUP™ will provide a seamless transparent process that gives detailed real-time data of high quality to ATL regarding every aspect of the study from recruiting to final visit. The ePDAT diary cards will collect electronic data that has been shown to be the most accurate mode of symptom collection in the industry” say Dr Piyush Patel, CEO of Inflamax Research. In separate discussions, the FDA has advised that EEC data will be accepted as part of pivotal registration trials. Inflamax has several studies in the planning stages which incorporate the mobile EEC technology in hybrid Field/EEC studies which incorporate EEC visits into the traditional allergy field study. Inflamax, on its own will begin the work immediately to set up an Investigator network to conduct the international study across three locations in the US and Canada using Inflamax’s proprietary mobile Environmental Exposure Chamber (mEEC™) system.
Inflamax Research’s mEEC™ system is a patent pending technology developed by Inflamax that allows the incorporation of EEC visits in any field allergic rhinitis study. Mobile EECs are designed such that an EEC site can be positioned at any location worldwide. Once a site is finalized the mobile EEC can be set up in as little as one week. Data collected in the EEC has been shown to be more discriminative, accurate, precise and less variable then data collected in traditional field seasonal or perennial rhinitis studies. Lower data variability also permits studies to have smaller sample sizes leading to cost and time efficiencies in drug development.
Inflamax is a full service Contract Research Organization (CRO) specializing in Proof of Concept as well as Phase I through IV studies in allergy, asthma, ocular and dermatology utilizing EEC technology. Inflamax conducts single and multi-center Environmental Exposure Chamber (EEC) and field studies. In addition to Inflamax Research’s Mobile EEC(TM) systems which can be positioned globally, Inflamax has 2 fixed EECs at Inflamax headquarters in Toronto, Canada. Inflamax’s EECs have been validated for the study of allergy to ragweed, grass and dry eye syndrome (utilizing low humidity EEC conditions). Validations are currently in process for cat and dust mite allergens and are expected to be completed in Q2’2013, thereby making the EECs suitable for clinical studies to test medications for perennial allergies.
About Dr Piyush Patel
Dr Piyush Patel, Inflamax’s CEO, is an industry veteran who has been in the forefront of development of EEC technology. Dr Patel is an author of several patents relating to EEC technology and was the owner of a CRO specializing in EECs called Allied Research International which he sold through a private equity financed buyout in 2007. Dr. Patel was named Entrepreneur of the Year in 2008 for his work in building that company.
About Allergy Therapeutics Ltd.
Allergy Therapeutics is a European-based specialty pharmaceutical company focused upon the treatment and prevention of allergy.