January 17, 2013; Toronto, Ontario, Canada – Inflamax Research, announces the development and validation of a unique Next Generation Mobile Environmental Exposure ChamberTM (EEC) system, which enables the pharmaceutical industry to perform single or multi-center EEC clinical trials in any location worldwide.
EEC technology is a clinical model that greatly enhances the sensitivity and specificity of pivotal clinical studies required for FDA drug registration. The Next Generation Mobile EEC technology consists of transportable clinical facilities to perform controlled allergen exposure; allergic subjects sit in a validated environment room and are exposed to a controlled level of airborne allergen. Subjects exposed to allergen in this environment develop allergic symptoms in a known, predictable manner. The subjects are asked to record instantaneous symptoms on a diary card. The resulting data are far superior compared to traditional methods of evaluating anti-allergic drugs in development.
“Up to now EEC studies could only be performed in a single center setting within a fixed EEC site. This has limited the usefulness of this powerful technology to small, single center studies in one geographic location. There have been major challenges in recruiting specific types of subjects for these studies due to the limited volunteer pool locally, as well, the available volunteers have already been treated with immunomodulators which in some cases, excludes them from participation in future studies. With the Next Generation Mobile EEC system and expert clinical Investigator consortium, we can now go to geographic locations where the volunteers are. With the availability of Inflamax’s Next Generation Mobile EEC system, we have noticed a significant decline in the interest in conducting fixed single site EEC studies from our clients in favor of the multi-center EEC approach.” says Dr Piyush Patel, CEO of Inflamax.
Inflamax has developed a network of Investigators in North America and Europe who will participate as sites to recruit subjects in diverse geographic locations for multicenter EEC trials. These investigator sites can recruit specific populations from their databases. With the availability of the Mobile EEC system, the potential pool of subjects is vastly increased.
“Our Next Generation Mobile EEC system provides the ability to utilize identical EECs in multiple locations. FDA has indicated that such a standardized EEC system would be required for pivotal multi-center EEC trials. We are working with clients on several hybrid field-EEC study designs that incorporate EEC exposure with traditional field study design, the first of these studies is slated to start in the next few weeks” says Dr. Piyush Patel.
Headquartered in Toronto, ON, Inflamax is a full service Contract Research Organization (CRO) specializing in Proof of Concept, and Phase I to IV studies in allergy, asthma ocular studies and dermatology. Inflamax has unique electronic data collection tools for single and multi-center EEC and field studies which greatly improve the quality and speed of data collection in clinical trials. In addition to the Next Generation Mobile EECs, Inflamax has two Next Generation EECs fixed in place at Inflamax headquarters in Toronto, ON. These EECs are already validated for Ragweed, Grass and Dry Eye (low humidity). Validations are currently in process for cat and dust mite allergens.
About Dr Patel
Dr. Piyush Patel, Inflamax’s CEO is an industry veteran who has been in the forefront of development in EEC technology. Dr. Patel is an author of several patents relating to EEC technology and has been involved in the development of many mainstay anti-allergy drugs and immunotherapies currently on the market. He was the owner of Allied Research International; a CRO specializing in EECs, which was sold in 2007. Dr. Patel was also named Entrepreneur of the Year in 2008 for his work in building that company.
For more information contact:
David Selkirk / Karen Shields
Director, Clinical Trial Management / Senior Director, Operations