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Inflamax Research selected by the Immune Tolerance Network and the National Institutes of Health to conduct a landmark clinical study on the underlying mechanisms of allergic inflammation.

Inflamax Research today announces a collaboration with the Immune Tolerance Network (ITN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), to conduct clinical research into the underlying mechanisms of allergy.

Mississauga, Ontario (PRWEB) May 21, 2013

Inflamax scientists worked closely with internationally renowned expert scientists of the ITN to design the study, which will provide critical insight into the usefulness of two key clinical models used in the study of allergy treatments, the Environmental Exposure Chamber (EEC) and Nasal Allergen Challenge (NAC) models. Although both the models are well recognized and supported by numerous publications, to date no direct comparison between the allergic responses evoked by them has been performed.

The study involves allergen challenge by the two methods, followed by collection of nasal secretions and blood work to identify the sequence of biomarkers and inflammatory cells involved in the early and late phase of the allergic reaction. Dr. Stephen Durham from the Imperial College London developed the NAC model, and he will be the study’s coordinating investigator. The protocol is being developed by Inflamax and the team at ITN.

“We are pleased that ITN and its group of internationally renowned scientists and clinicians, after reviewing the other available EEC facilities, chose to collaborate with Inflamax on this project. This highlights the unique and very high caliber of scientific expertise and experience that we provide. Collaborations and projects like this underline our core vision and mission to develop and provide the best, scientifically validated models to our clients.” Says Dr Piyush Patel, MD, CEO of Inflamax Research. “Inflamax provides the best of client focused CRO services with scientific expertise which is unparalleled even in the top academic institutions”.

“Sponsor organizations wishing to conduct clinical trials utilizing allergen challenge models including the EEC, need to ensure that the study is properly designed. So doing this kind of basic research reinforces the confidence in data validity, and increases the likelihood that regulators around the world accept the data. The scientific staff at Inflamax have designed and conducted many mechanistic, proof of concept and pivotal studies utilizing multiple allergen challenge models, and are the experts in both scientific design and EEC trial methodology.” says Dr. Anne Marie Salapatek, President and CSO of Inflamax.

Inflamax is developing in-house capability to measure biomarkers and has the expertise to recommend specific biomarkers to assay in order to understand the underlying mechanism of action. Typical markers for consideration may include IL1, IL5, Eosinophil Cationic Protein (ECP), tryptase and Th2 cytokines, specific immunoglobulin (IgG, IgG4, IgA, IgE, and FAB), basophil activation and HLA assays.

About Inflamax

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 EECTM systems which can be positioned globally, Inflamax has 2 fixed EECs at Inflamax headquarters in Toronto, Canada. Inflamax’s EECs have been validated for study of allergy to ragweed, grass, cat and dust mite, as well as dry eye syndrome (utilizing low humidity EEC conditions).

About ITN

The Immune Tolerance Network (ITN) is an international clinical research consortium sponsored by NIAID, part of the National Institutes of Health.

Contact

  • Cynthia Day O’Brien, Senior Director, Business Development
    Inflamax Research
    (507) 252-1749

Inflamax Research Chosen to Conduct a Multicenter Environmental Exposure Chamber Phase 3 Study of Ultrashort Grass Allergy Vaccine by Allergy Therapeutics (UK) Ltd.

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.

About Inflamax

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.

Poster Presentations

Date: February 27, 2013 2:14pm EST

Inflamax Research recently presented three posters at an Allergy and Immunology conference. The topics of the posters were the following:

  1. Mobile Environmental Exposure Chamber (mEEC)
  2. Electronic Patient Data Acquisition Tool (ePDAT)
  3. Natural Exposure Chamber Unit (NEC)

 

All three posters are available for viewing in PDF format by clicking on the topic (above).

Inflamax Research Appoints Dr. Anne Marie Salapatek President & Chief Scientific Officer

Inflamax Research Inc., a specialty Clinical Research Organization focused on allergy and asthma research utilizing their Next Generation Environmental Exposure Chamber (EEC) technology, today announced the appointment of Dr. Anne Marie Salapatek as President & CSO.

Toronto, Ontario (PRWEB) February 18, 2013

Inflamax Research Appoints new CSO, Dr. Anne Marie Salapatek

Dr. Anne Marie Salapatek

Dr. Salapatek is an internationally renowned scientist with expertise in allergy, asthma and EEC clinical trials. Previously she was the Principal Scientist at Cetero Research (formerly Allied Research International) where she was responsible for the development and validation of new Allergy and Asthma clinical models, advising clients on study designs including utilizing EEC technology for seasonal and perennial allergies, asthma, non-allergic rhinoconjunctivitis and COPD. Dr. Salapatek has worked with many clients to realize their drug development program goals by providing expert study design, regulatory strategy, and data analysis and interpretation. Dr Salapatek has presented her research at numerous international meetings including the FDA workshops and Advisory Panels on the utility of Environmental Exposure Chambers in pivotal, Phase 3 studies.

“I have worked with Anne Marie before and I am delighted that she has joined us at Inflamax Research, where her extensive experience in Environmental Exposure Chambers and drug development will prove invaluable to our clients,“ said Dr. Piyush Patel, Inflamax’s CEO. “Dr. Salapatek has close working relationships with numerous key opinion leaders and scientists in the pharmaceutical industry, as well, she has a proven track record in designing and overseeing complex Phase 1 to 4 clinical trials She brings a high caliber of scientific credibility, rigor and integrity which is at the core of Inflamax’s approach to clinical research. With the addition of Dr. Salapatek’s expertise to our science team, Inflamax now has unparalleled capability to design and perform complex large and small clinical trials using EEC technology.”

“I am excited to join Inflamax Research and look forward to helping to lead and shape a company that has as its core tenet: “Scientific Excellence in Clinical Research”.” said Dr. Salapatek. “ I am pleased to work with the high caliber staff at Inflamax who are extremely skilled and experienced in the field of EEC and allergy/asthma research. I look forward to working with our clients who are engaged in the development of future medications and who deserve the best service in these critically important endeavors.”

Dr. Anne Marie Salapatek has over 20 years’ research experience both in industry and academia. She is the author of over 100 publications including patent inventions in topics ranging from inflammatory mechanisms to clinical trial design, conduct and Environmental Exposure Chamber technology. Dr. Salapatek was awarded a Ph.D. in Pharmacology from McMaster University, MSc in Physiology and BSc in Biochemistry from University of Toronto, Canada. Dr. Salapatek was the recipient of Canadian Institute of Health Research’s Principal Investigator funding and appointed Assistant Professor in the Faculty of Medicine at the University of Toronto conducting well-funded research in the areas of respiratory, diabetes and gastroenterology. She was the recipient from the Lieutenant Governor of Ontario of the prestigious John Polanyi Prize (Nobel laureate) recognizing excellence in research in Canada. Dr. Salapatek brings to Inflamax Research a strong academic background coupled with extensive experience in clinical drug development in partnership with client Sponsors. She has advocated the use of the EEC model for allergy and dry eye research in regulatory and research forums demonstrating their benefit to improving the accuracy and precision of clinical research.

About Inflamax

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 disease 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™ systems which can be positioned globally, Inflamax has 2 fixed EECs at Inflamax headquarters in Toronto, Canada. Inflamax’s EECs have been validated for study of allergy to ragweed and grass and also for the study of 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 Q1’2013, thereby making the EECs suitable for clinical studies to test medications for perennial allergies.

Inflamax Research Introduces Electronic Patient Data Acquisition Tablet™ (ePDAT)™ for Real-Time PRO Data Collection

Inflamax Research today announced the introduction of its electronic Patient Data Acquisition Tablet™ (ePDAT)™ which not only facilitates, but also standardizes Patient Reported Outcomes (PRO) data collection across multi-center clinical trials. Pharmaceutical sponsors, clinical researchers and patients now have a significantly improved user experience, accuracy and quality in collecting patient reported data for clinical trials.

Toronto, Ontario (PRWEB) January 30, 2013

PRO data is recognized by most regulatory authorities including the FDA and EMA as important and acceptable endpoints in clinical studies. PRO have historically been recorded on paper diaries requiring subsequent transcription which can introduce human error, data queries and time delays. Its electronic format (ePRO) offers many inherent benefits including increased quality and reduced time to database hard lock. Due to legacy software issues and logistics, this tablet-based technology has not been available from other vendors. Inflamax has devoted considerable time and resources to develop its ePDAT™ system to improve user experience, accuracy and quality, while ensuring compliance with FDA and EMA requirements for validated ePRO data collection tools. ePDAT™ is fully CFR21 part 11 compliant.

ePDAT Detailed ProspectusAttachment
ePDAT Detailed Prospectus

 

“Although ideal for any type of PRO data collection, the ePDAT™ is the first ePRO system specifically designed to meet the needs of allergy and asthma clinical trials as well as Environmental Exposure Chamber (EEC) studies. Data can be collected in the EEC and at home with ease. Our validation studies have shown an enormous preference to using this system versus the traditional paper diaries. We are excited to have this technology available for our upcoming EEC and field hybrid studies. This is the first ePRO system that is capable of next-generation e-data acquisition including geo-positioning, Intelligent Follow-on™ questions and Smart Compliance™ measures built into the base software.” says Dr. Piyush Patel, CEO of Inflamax.

Time point questions appear on the screen in multiple formats.

Time point questions appear on the screen in multiple formats.

The validated ePDAT™ system provides a graphical user interface via a touch screen tablet computer designed to provide a vastly improved user experience. PRO data can be collected by a number of methods which include on-screen questionnaires, visual analog scales (VAS), response time, coordination tasks, high resolution image capture and evaluator interview via video conferencing. Security features include unique password and free hand signatures. Improved software architecture allows patient data to be recorded in real-time directly via the tablet’s cellular wireless connection to our secure database servers. The data are also stored locally on the tablet as back-up. Hard locked data in any format required by the client is available as soon as the last subject is completed.

loginScreen

Users Login with unique User ID and Password

Inflamax’s Smart Compliance™ system incorporates built-in compliance feedback involving the Inflamax Compliance Team communicating real-time with enrolled subjects via push messages, text messages and video or audio links. Compliance enhancing initiatives including newsletters can be pushed to the tablet as needed. Studies have shown that such enhanced compliance measures significantly improve the compliance and quality of data collected in clinical

questionScreen

Questions can be pushed to the user at timed intervals

trials. Intelligent Follow-on™ allows for protocol-specific, pre-programmed and approved, follow-on questions to be posed based on previous responses for PRO and adverse event data collection.

The ePDAT™ system was developed in partnership with Logos Technologies, the leaders in early phase data acquisition technology. The Inflamax phase one unit already has ALPHADAS,

ePDAT Visual Analog Scale Interface

ePDAT Visual Analog Scale Interface

Logos Technologies’ pre-eminent eSource bedside EDC system, enabling paperless phase I studies that deliver real time ‘report ready’ data. ePDAT™ integrates with ALPHADAS to ensure seamless data delivery for Inflamax sponsors and partners.

 

 

 

About Inflamax

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™ systems which can be positioned globally, Inflamax has 2 fixed EECs at Inflamax headquarters in Toronto, Canada. Inflamax’s EECs have been validated for study of allergy to ragweed and grass and also for the study of 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 Q1’2013, 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 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.

Inflamax Research announces the launch of its Next Generation Mobile Environmental Exposure Chamber™ for conduct of Allergy & Asthma Trials

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.

Attachment
Mobile Environmental Exposure Chamber (EEC) Detailed Prospectus

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.

Inflamax Research's Mobile EEC

Inflamax Research’s Mobile EEC

“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.

About Inflamax

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
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