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Phase 2 Trial of Infecton Initiated
This clinical trial is a single-dose, open-label, multi-center trial involving patients with signs and symptoms of bacterial osteomyelitis and will be conducted at designated centers in the United States. Enrollment will begin immediately and will continue into the beginning of 2005. The principle investigator is Dr. Christopher J. Palestro of the Long Island Jewish Medical Center.
"This additional Phase II study will allow us to examine the use of INFECTON(R) for molecular imaging in difficult cases of osteomyelitis, a serious and debilitating problem, that is currently very difficult to diagnose or follow," said Dr. Richard J. Flanagan, President of DRAXIMAGE Inc. "We believe that INFECTON(R) has the potential to replace several existing imaging procedures that are non-specific for infection, including white blood cell imaging, which is not only complex but also involves some risk in the handling of human blood. INFECTON(R) should also permit the long-term monitoring of the success of antibiotic therapy in osteomyelitis."
The three Phase II studies for INFECTON(R) now being conducted in Canada and the United States follow the successful completion of a Phase I safety and dosimetry trial in Canada in 2003. The Phase I study examined product safety, pharmacokinetic parameters and radiation dosimetry in normal healthy volunteers and INFECTON(R) was found to be safe and well tolerated by the subjects at the administered dosages. In addition, INFECTON(R) has previously been studied outside North America in a multi-centre clinical research project involving a series of 879 patients and co-ordinated by the International Atomic Energy Agency.
Osteomyelitis is an acute or chronic bone infection, usually caused by bacteria. The infection that causes osteomyelitis usually originates in another part of the body and spreads to the bone via the blood. Affected bone may have been predisposed to infection because of recent trauma. In children, the long bones are usually affected, while in adults, the vertebrae and the pelvis are the most commonly involved. Bone infection is most often caused by bacteria but can also be caused by fungi. Chronic osteomyelitis results when bone tissue dies as a result of the lost blood supply. Chronic infection can persist intermittently for years. The incidence of osteomyelitis is approximately 2 in 10,000 people.
INFECTON(R) is the proprietary combination of the widely used antibiotic, ciprofloxacin, with Technetium (99mTc), the most commonly used radioisotope in nuclear medical imaging. The INFECTON(R) kit for the preparation of 99mTc-ciprofloxacin is a diagnostic radiopharmaceutical that has the potential to selectively distinguish infection from inflammation by binding directly with an essential component of the bacterial DNA replication system.
It is anticipated that INFECTON(R) will be useful for the molecular imaging of infection in several serious medical conditions such as fever of unknown origin, osteomyelitis, pneumonia, tuberculosis, wound infection, abdominal abscess, equivocal appendicitis and opportunistic infections in immune compromised patients.
Source: DRAXIMAGE Inc.