“Fred Hutch selected OriCol for this HIV prevention study after experiments testing and optimizing the device in control subjects,” Paul Weinberger, Origin Sciences' CEO told Outsourcing-Pharma.com.
“The main criteria for OriCol selection was the collection time is less when compared to our usual secretion collection methods while still obtaining a similar sample.”
Weinberger explained the device allows clinicians to take secretion samples in less time, adding that this “typically means increased participant comfort.”
The sampling device
UK-based Origin Sciences developed The OriCol™ Sampling Device to enable clinicians to collect a unique mucosal sample for detection and diagnosis of gastrointestinal diseases.
According to the company, samples can be used in a range of downstream analyses including investigation of DNA, proteins, antibodies and the microbiome.
The Phase I HIV study
As part of the study, mucosal samples will be collected from the rectum of the study subjects. The samples will then be measured for Immunoglobulin (IgG) levels to monitor patients’ responses to experimental treatment.
The Phase I study will test two experimental antibodies: VCR01 and VCR01LS, which Fred Hutch said can recognize and block many HIV forms. It has also shown an ability to block HIV infection in previous studies.
According to the company, the study’s aim is to evaluate the safety, pharmacokinetics, and antiviral activity of VRC01 and VRC01LS in the serum and mucosa of healthy, HIV-uninfected adults.