clinical
The biopharmaceutical industry standard is to employ costly outside contractors to manage clinical development of new candidate drugs. XBiotech keeps clinical operations in house, so it is able to quickly and efficiently execute clinical studies for a fraction of the cost of outside contractors.
CLINICAL Operations
XBiotech has performed clinical studies across the United States and Europe. Management of these complex programs—from protocol creation, IND filings, and FDA negotiations; to development of electronic data capture system, recruitment of vendors and clinical partners, through monitoring of clinical sites; to database lock and analysis—all is done in-house.
Clinical Studies
XBiotech has completed numerous studies across various indications.
For seventy-years oncology therapy has centered around the use of chemotherapy agents, that are essentially extremely potent poisons designed to kill tumors. Unfortunately, in thousands of clinical trials, these agents have proven in many cases to be only marginally effective against tumors and to exhibit brutal toxicities. XBiotech is taking a different approach. Inflammation is literally the life-blood of tumors. Inflammation stimulates the growth of new blood vessels that feed tumors, results in breakdown of tissue to allow growth and spread, and causes a host of other molecular and systemic events that enhance tumor growth and cancer-related illness, respectively.
Reperfusion of ischemic brain tissue is often associated with expansion of irreparably damaged brain tissue. After reperfusion, hypoperfused (hypoxic) brain tissue that appeared viable by both physical imaging and metabolic assessment is lost as an ischemic core. Increase in ischemic infarct core following reperfusion may result from an inflammatory insult from the return of blood flow. Our True Human™ antibodies precisely targets IL-1α to block activation of the Interlukin-1 (IL-1) pathway during reperfusion. This approach offers the potential to interrupt the sterile inflammatory insult that occurs as a result of reperfusion.
IL-1α has been implicated in having a role in the progression of Rheumatoid Arthritis. Arthritis patients positive for IL-1α antibodies have been shown to have milder disease manifestation, compared to those who are negative or have lower titers of IL-1α antibodies. Early experimental studies in mice with collagen induced arthritis have shown that the presence of IL1 antibodies ameliorates both early and full-blown arthritis. We hope to utilize our IL-1⍺ targeting True Human™ antibodies to similarly reduce the disease severity in a number of rheumatological conditions.
Our True Human™ antibodies are capable of targeting key components of immune evasion and virulence in a variety of pathogens allowing for augmentation of existing anti-infective therapies.
Modern medicine should help patients feel better, not worse. At XBiotech, we believe in the Hippocratic principle of "do no harm." We believe this is inherent to the innovative True Human™ antibody medicines we are developing. True Human™ antibodies move beyond the idea that effective medicines must come with toxicity or harmful side effects.
By utilizing the body’s natural immune system, XBiotech develops therapies that help you heal and feel better.