OVERLAND PARK, Kan.; August 2, 2023 – Dr. Vince Clinical Research (DVCR), a full-service CRO specializing in Phase I-II clinical trials, announced today the first subject was screened for Cessation Therapeutics’ CSX-1004 in a First-In-Human single ascending dose study in normal healthy volunteers. CSX-1004 is a human monoclonal antibody infusion that is being developed for the prevention of fentanyl overdose. The study is being conducted at DVCR’s world-class clinical pharmacology unit located in Overland Park, Kansas.
Currently, opioid-related overdose is the leading cause of death for Americans between the ages of 18 and 45, with over 200 deaths per day. Fentanyl and similar synthetic opioids are the main sources of the epidemic. Fentanyl can cause death within minutes of exposure to a lethal dose (more quickly than heroin or prescription opioids), which limits the effectiveness of current treatments. Thus, there is a need to develop new therapies which are aimed at preventing overdose. CSX-1004 potently binds to fentanyl and structurally related synthetic opioids, blocking them from entering the brain.
“Our company is privileged to be involved in the early clinical development of a first-in-class compound that could potentially provide a viable alternative to healthcare providers in their battle against the opioid epidemic, specifically with fentanyl,” says Brad Vince, D.O., CEO and Medical Director. “The team at Dr. Vince Clinical Research possesses deep industry experience in conducting First-in-Human trials with monoclonal antibodies as well as for drugs for substance abuse”
In addition to clinical conduct at its Phase I unit, DVCR will provide project management, data management, biostatistics, and monitoring services to Cessation. Their cGMP compliant pharmacy, featuring a team with over 50 years of combined clinical research experience, provided extensive guidance on the preparation of CSX-1004 for dosing and associated infusion supplies.
Cessation’s Chief Scientific Officer Andy Barrett, Ph.D., stated, “We are thrilled to partner with Dr. Vince Clinical Research on this critical First-In-Human study. Given the unit’s deep expertise in early phase studies, it was a logical choice to study a potentially paradigm-shifting therapy in the fight against fentanyl.”
DVCR looks forward to successfully completing this critical path study for Cessation’s potentially ground-breaking therapy and joining the effort to combat the fentanyl crisis in America.
About Dr. Vince Clinical Research
Dr. Vince Clinical Research (DVCR) is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and multiple therapeutic areas such as neuroscience, psychiatry, substance abuse, pain, cardiometabolic disorders, infectious diseases and others. CRO services include project management, data management, biostatistics, monitoring, PK/PD analysis, medical writing as well as site feasibility and management for multi-center trials. Additionally, DVCR operates one of the most innovative and technologically advanced clinical pharmacology units in the world with over 90 beds for overnight confinement, a cGMP compliant pharmacy as well as luxurious amenities to support diverse study participant recruitment and retention. By leveraging technology and one of the country’s most experienced leadership teams in early clinical development, DVCR provides Smarter Faster Data® to their biopharmaceutical clients.
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Zach Bader
Vice President, Business Development
(913) 333-3000
Dr. Vince Clinical Research
zbader@drvince.com