Latest News & Updates
First US Multi-Center Mobile EEC Study Fully Enrolled
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
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 can lead to....Read the whole story
Innovator displays habit of breaking new ground
In many ways, Dr. Piyush Patel, founder, CEO and medical director of Inflamax Research, a full-service clinical research organization, has come full circle. Patel built his first company, Allied Research International, into a world leader and Best Managed company in the clinical research space with 850 employees and operations in Toronto, Montreal, Miami and Delhi. He sold that company in 2007 and five years later he bought back the assets and launched Inflamax Research to continue the work coming out of the groundbreaking research model he had created at Allied Research.
That model is based on its unique environmental exposure chambers (EEC). A physician trained in allergy and respiratory diseases, he developed an innovative way to perform the studies necessary to develop vaccines for allergies and respiratory diseases. Clinical studies are undertaken in an EEC where allergens are dispersed at a level that ensures participants display symptoms. “Then we can look at how they respond to treatment,” says Patel. “It is controlled and far less variable than other models.” The result: better, faster, cheaper studies for clients that include the likes of the U.S. Department of Health’s National Institutes of Health as well as global biotech and pharmaceutical companies.
Since launching in 2012, Inflamax has grown from 20 employees to 350 and revenues in 2015 grew about 80 per cent from 2014. That growth is expected to continue. In early 2015, it launched its mobile EEC — the first of its kind. The company has set up a subsidiary in New Jersey and plans to launch in Japan and Europe.
Link to article on FinancialPost.com
Positive Results from a Phase IIa Allergic Conjunctivitis Trial
Inflamax Research Announces Today Positive Results from the Phase IIa Allergic Conjunctivitis Trial Testing a Novel Aldehyde Trap from Aldeyra Therapeutics
The study was conducted at Inflamax’s Toronto, Canada site and involved the use of the Conjunctival Allergen Provocation Test (CAPT) in patients with moderate to severe seasonal allergic conjunctivitis. The single-site study successfully randomized 100 subjects and used Inflamax’s innovative electronic diary system (ePDAT™) and electronic (paperless) data capture system (QDAQ™). The trial demonstrated statistically significance differences (p<0.05) between the NS2 treated group and the vehicle control group in ocular itching and tearing. NS2 was well-tolerated with no safety concerns. No serious adverse events were reported, and 98% of patients completed the trial.
“We are pleased to announce these positive and exciting results for Aldeyra’s NS2 ophthalmic solution and are impressed with this compound’s efficacy in allergic conjunctivitis,” said Dr. Holly Lorentz, Manager of Ocular Research at Inflamax Research....Read Full Story
Local Entrepreneur Completes Elite Ivey Program
Inflamax Research Inc. is pleased to announce today that Dr. Anne Marie Salapatek has completed QuantumShift, a unique leadership development program and network sponsored by Ivey, KPMG Enterprise, TD, and The Globe and Mail.
Boosting entrepreneurial talent is critical for our country’s future. Successful CEOs and business leaders from across Canada have just finished an intensive program at the Ivey Business School in London, Ontario. These entrepreneurs are on the way to taking their companies to the next level.
Helping private businesses grow and improve their productivity is essential to building a more competitive Canada. Ivey Business School and KPMG Enterprise realize this and for the 12th year they invited a select group of entrepreneurs to participate in QuantumShift, a rigorous...Read Full Story
Inflamax Research to Present Data Demonstrating Validation of Environmental Exposure Chambers for Pivotal Allergy Research at the Paul-Ehrlich Institute in Germany
Dr. Anne Marie Salapatek will be discussing the validation of environmental exposure chambers (EECs) for use in pivotal clinical trials and how this clinical approach should be examined rationally for its utility in pivotal immunotherapy testing for allergies.
Inflamax Research Inc., a full-service CRO, announced today that their Chief Scientific Officer, Dr. Anne Marie Salapatek, has been invited to speak at the 14th International Paul-Ehrlich Institute Seminar on Allergen Products for Diagnosis and Therapy: Regulation and Science, held in Bad Nauheim, Germany from October 29th to November 1st, 2014. The international seminar has been an expert forum and medium for discussion for scientists and regulators for approximately 30 years. This year’s event will address industry standardization and regulatory issues related to diagnostic and therapeutic allergen products.
Dr. Salapatek will review the validation methods utilized for EEC clinical trials, including the selection of ...Read Full Story
Dr. Anne Marie Salapatek, CSO at Inflamax Research, will be presenting clinical trial data demonstrating the utility of Environmental Exposure Chambers in asthma and allergic rhinitis research at upcoming 2014 European Respiratory Society conference in Munich, Germany, September 6-10.
Inflamax Research Inc., a full-service CRO, announced today that their Chief Science Officer, Dr. Anne Marie Salapatek, will be presenting clinical trial data demonstrating how Environmental Exposure Chambers (EECs) can be utilized for the development of clinical trial programs aimed at showing safety and efficacy without the need for costly, large scale field studies.
The data being presented, across three poster presentations, is a representation of study design types that demonstrates how baseline allergic rhinitis symptoms can be provoked consistently out of allergy season. Patients are treated with an investigational or already-approved product, and then provoked again post-treatment to determine...Read Full Story
Dr. Anne Marie Salapatek, President & Chief Scientific Officer of Inflamax Research, will be presenting results of a meta-analysis outlining statistically significant correlations between house dust mite symptoms in the traditional Field trial approach and those collected from patients in the Environmental Exposure Chamber (EEC). These findings support the use of EEC allergen challenge approach for pivotal testing.
Dr. Salapatek, an internationally renowned scientist with expertise in allergy, asthma and EEC clinical trials, is an invited speaker at the EAACI meeting. “This data shows that conducting studies in the EEC provides the best research option that reduces the variability seen in field trials whilst providing an accurate read of a therapy’s efficacy, and importantly also which well reflects that seen in the traditional field trial approach”, states Dr. Salapatek. These findings are to be presented at the 2014 The European Academy of Allergy and Clinical Immunology (EAACI) Congress in Copenhagen, Denmark on June 10th at 1:30 pm.
Dr. Salapatek will also be presenting a poster demonstrating that correlations between skin prick tests (SPT) and specific IgE levels in patients vary...Read Full Story
Read All News at Inflamax Research
Released October 24, 2013
The CDM team has experience with electronic data capture services, having built, released, and “locked” 375
databases since 2006 in multiple study designs and therapeutic areas. All team members are members of the
Society for Clinical Data Management (SCDM) and all have achieved their Certified Clinical Data Manager
The utilization of CDISC and CDASH standards provides the industry-standard data exchange
models which facilitates submission for FDA requirements. In addition to a full complement of data
management services, including web-based fully compliant 21 CFR Part 11 electronic data capture capability
via secure Internet access, Inflamax Research Inc. has integrated its e-Source data capture in the clinic
seamlessly into good data management practices...Read Full Story