Monthly Archives: March 2016

Inflamax Research Inc. Announces the Successful Completion of Enrollment for the First Multi-center, Mobile Environmental Exposure Chamber (mEEC™) Study

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.

Inflamax Research Announces Positive Results of a Phase IIa Allergic Conjunctivitis Trial Testing a Novel Aldehyde-Trapping Molecule from Aldeyra Therapeutics

Positive results from a single-centre, double-masked, randomized, vehicle-controlled Phase IIa study in allergic conjunctivitis patients treated with NS2 ophthalmic solution from Aldeyra Therapeutics, Inc.

TORONTO, ON (PRWEB) MARCH 03, 2016

Inflamax Research Inc., a global full-service CRO specializing in inflammatory disease, announced positive results from a single-centre, double-masked, randomized, vehicle-controlled Phase IIa study in allergic conjunctivitis patients treated with NS2 ophthalmic solution from Aldeyra Therapeutics, Inc. (NASDAQ:ALDX). 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.

Dr. Anne Marie Salapatek, President and Chief Scientific Officer at Inflamax Research, commented, “As a CRO with expertise in testing putative treatments for a variety of inflammatory diseases, Aldeyra’s unique aldehyde-trapping approach appears promising in ocular inflammatory diseases such as allergic conjunctivitis, and we look forward to continuing to work with Aldeyra on the clinical advancement of this novel aldehyde trap program.”

Allergic conjunctivitis is experienced by approximately 40% of the population and is thought to be mediated in part by pro-inflammatory aldehydes and leads to inflammation of various parts of the eye and eyelids, with corresponding symptoms of that often include itching, burning, tearing, sensitivity to light, redness, swelling, and mucus discharge.

Inflamax Research is a full-service, global CRO specializing in allergy, ocular and respiratory diseases, led by world-known, key-opinion leaders. Inflamax has a strong academic background and publishes extensively in peer-reviewed journals. Inflamax is experienced in the conduct of large single and multi-centre trials using their innovative fixed and mobile Environmental Exposure Chambers and direct instillation models from a study’s concept to protocol writing, site management, data management, and medical writing. Inflamax’s scientists and clinicians are well known to regulatory authorities and regularly participate in an advisory role.