OR WAIT null SECS
, an early-stage contract research organization (CRO), announced achievements for its Environmental Exposure Chambers (EECs), or allergy models for recreating environmental conditions. Over the past nine years, Cetero has used these models in more than 40 clinical studies to help its pharmaceutical partners develop novel therapies for a wide range of anti-allergic small molecule drugs, immunotherapies, biologics, and therapeutic devices.
Cetero’s EECs can reliably reproduce peak allergy season year-round to test for seasonal allergies, including ragweed and grass and tree pollens, as well as perennial allergies including cat dander and dust mites. The allergy models can also be used for asthma and other conditions, such as conjunctival, nasal, and bronchial allergen challenges, and intracutaneous testing. The newest chamber can test for both non-allergic rhinoconjunctivitis and dry eye.
“We know how important it is to keep clinical trials on schedule. Waiting for ragweed season or a cold dry day can significantly delay a development program,” said Dr. Troy McCall, CEO of Cetero Research. “Our validated EEC models guarantee stable, reliable conditions for testing a range of conditions all year-round.”
With the EECs, subjects are continuously monitored within the custom-built facilities by highly-trained staff, which means maximum compliance in symptom recording. The resulting high-symptom scores and lower variability maximize the sensitivity of the allergy models, requiring fewer patients to be tested to discern treatment efficacy. Furthermore, as the subjects are confined at Cetero’s clinical facility, trained staff can accurately measure a number of objective ocular, nasal, and lung function variables and biomarkers, which is difficult to do when subjects rate their own symptoms from outside the controlled environment of Cetero’s site.
“Cetero’s allergy models, combined with our proven bioanalytical expertise and support from our Scientific Affairs team, offer incredible flexibility for our clients,” said Dr. Murray Ducharme, Chief Science Officer for Cetero Research. “We can conduct elements of the study, such as program development consultation, method validation, sample analysis, or proof-of-concept studies. We can also offer complete turnkey studies, if that is what our clients want.”
Cetero has six EECs developed and fully validated for Good Clinical Practice (GCP)-compliant studies. Data from these allergy models are accepted by the U.S. Food and Drug Administration (FDA), the Canadian Therapeutic Products Directorate (TPD), Medicines Control Agency (MCA) in the United Kingdom, and the European Medicines Agency (EMEA), which makes the testing even more valuable for companies looking to sell their products worldwide.
“We know that pharmaceutical and medical device manufacturers are looking for ways to improve efficiencies while maintaining the highest quality standards,” added Dr. Murray Ducharme. “The allergy model studies provide data from fewer patients in a more controlled setting that can be used in multiple jurisdictions. Importantly, Cetero can also provide hybrid studies that combine Phase I and proof-of-concept, offering even further efficiencies that can help companies manage timelines and bottom lines in clinical trials.”