DRAXIS Initiates Phase II Trial of INFECTON'R' in the United States.MISSISSAUGA, Ontario -- FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approves additional study for molecular imaging in osteomyelitis osteomyelitis (ŏs'tēōmī'əlī`tĭs), infection of the bone and bone marrow. Direct infection of bone usually occurs through open fractures, penetrating wounds, or surgical operations. DRAXIMAGE Inc., the radiopharmaceutical subsidiary of DRAXIS Health Inc. (Nasdaq: DRAX) (TSX: DAX) has received approval from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA) to initiate a Phase II clinical study of INFECTON(R), a novel radiopharmaceutical molecular imaging agent for detecting and determining the location of difficult-to-diagnose infection in the body. This study will examine patients suffering from bacterial osteomyelitis, a chronic or acute infection of the bone. Two other trials with INFECTON(R) are currently being conducted in Canada, one involving diabetic patients suffering from bacterial infections of the foot and the other in patients with either known soft tissue infections or chronic inflammatory conditions. 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 Long Island Jewish Medical Center (LIJMC) shares the title of clinical and academic hub of the North Shore-Long Island Jewish Health System. It is an 827-bed voluntary, non-profit tertiary care teaching hospital serving the greater metropolitan New York area. . "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 de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction 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 The United States and Canada share a unique legal relationship. U.S. law looks northward with a mixture of optimism and cooperation, viewing Canada as an integral part of U.S. economic and environmental policy. 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 International Atomic Energy Agency: see Atomic Energy Agency, International. International Atomic Energy Agency (IAEA) International organization officially founded in 1957 to promote the peaceful use of nuclear energy. . 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 Vertebrae Bones in the cervical, thoracic, and lumbar regions of the body that make up the vertebral column. Vertebrae have a central foramen (hole), and their superposition makes up the vertebral canal that encloses the spinal cord. 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 technetium (tĕknē`shēəm) [Gr. technetos=artificial], artificially produced radioactive chemical element; symbol Tc; at. no. 43; mass no. of most stable isotope 98; m.p. 2,200°C;; b.p. 4,877°C;; sp. gr. 11. (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 Fever of Unknown Origin Definition Fever of unknown origin (FUO) refers to the presence of a documented fever for a specified time, for which a cause has not been found after a basic medical evaluation. , osteomyelitis, pneumonia, tuberculosis, wound infection, abdominal abscess, equivocal appendicitis Appendicitis Definition Appendicitis is an inflammation of the appendix, which is the worm-shaped pouch attached to the cecum, the beginning of the large intestine. The appendix has no known function in the body, but it can become diseased. and opportunistic infections in immune compromised patients. About DRAXMAGE Inc. DRAXIMAGE discovers, develops, manufactures and markets diagnostic imaging and therapeutic radiopharmaceuticals for the global marketplace. Products currently marketed by DRAXIMAGE include a line of lyophilized ly·oph·i·lize tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es To freeze-dry (blood plasma or other biological substances). [lyophil(ic) + -ize. technetium-99m kits used in nuclear imaging procedures, a line of imaging and therapeutic products labeled with a variety of isotopes including radioiodine radioiodine /ra·dio·io·dine/ (-i´o-din) any radioactive isotope of iodine, particularly 123I, 125I, and 131I; used in diagnosis and treatment of thyroid disease and in scintiscanning. , and BrachySeed(R), a next-generation brachytherapy implant for treating prostate cancer. DRAXIMAGE has several products in late-stage development, including two technetium-99m-based diagnostic imaging products: FIBRIMAGE(R) for imaging deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. currently in Phase III in Canada and INFECTON(R) for imaging infection currently in Phase II. About DRAXIS Health Inc. DRAXIS Health Inc. (www.draxis.com) is a specialty pharmaceutical company involved in the development, production, marketing and distribution of therapeutic and diagnostic radiopharmaceuticals through DRAXIMAGE Inc. and in the provision of pharmaceutical contract manufacturing services, specializing in liquid and freeze-dried injectables and other sterile products through DRAXIS Pharma Inc. DRAXIS Health employs over 450 staff and reported revenues in 2003 in excess of US$49 million. Except for historical information, this news release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 as amended, which involve risk and uncertainties that may cause actual results to differ materially from the statements made. Such factors include, but are not limited to, timely regulatory approval of the Company's products, the ability to obtain and enforce effective patents, the establishment and maintenance of new corporate alliances, compliance with appropriate governmental regulations, and other risks detailed from time-to-time in the Company's filings with the US Securities and Exchange Commission and Canadian securities authorities. The Company does not undertake to update such forward-looking statements to reflect new information, later events or developments. |
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