Xcellerex Begins Phase I Clinical Trial Evaluating XRX-001

XRX-001 is an inactivated virus vaccine adsorbed to alum adjuvant. As it is inactivated and non-replicating, it is anticipated to reduce the risks of serious and fatal adverse events that are sometimes associated with the live yellow fever vaccine.

In addition, Xcellerex believes that the XRX-001 vaccine should not be subject to the precautions and contraindications of the currently marketed live vaccine.

The double-blind, controlled phase I trial is expected to enroll 60 healthy subjects divided into three groups. Two groups of volunteers will receive two different dose levels of XRX-001 and the third will receive placebo.

The primary objective of the trial is to evaluate the safety and tolerability of XRX-001 vaccine, and secondary objectives will assess the neutralising antibody response, an accepted correlate of protective immunity to yellow fever. In a second parallel trial, the company will compare the antibody response in those receiving XRX-001 to travelers receiving the currently-marketed vaccine.

Joseph Zakrzewski, president and CEO of Xcellerex, said: “The initiation of the Phase I clinical trial is a significant milestone for Xcellerex and is further validation of both our disposable manufacturing technology and business model.

“We have manufactured XRX-001 using our proprietary, disposable technology and believe that XRX-001, if approved, will offer patients a safer alternative than the existing live virus vaccine currently on the market. The XRX-001 pre-clinical data are very encouraging and we are excited about the opportunity to bring our first proprietary product into the clinic.”