OXO CHEMIE AG INITIATES MACROKINE PHASE 2 CLINICAL TRIALS.OXO OXO Også (Norwegian: as well, too) Chemie AG, South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , has initiated Phase 2 clinical trials of their macrophage-regulating drug, MACROKINE(R) (WF10), in patients with chronic active hepatitis chronic active hepatitis 1. Obsolete term. See Chronic hepatitis2. Chronic viral hepatitis C virus (HCV HCV
hepatitis C virus
HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. ) disease. To date, 22 of the planned 80 patients have been enrolled in the studies being conducted in Germany and Hong Kong prior to the initiation of international multicenter studies. MACROKINE(R) (WF10) is a proprietary chlorite-containing drug currently in Phase 3 studies of patients with advanced HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. disease in the U.S.
The objective of the HCV studies is to determine the effect of MACROKINE(R) (WF10) on liver enzymes, necroinflammatory changes assessed by histologic activity index (HAI) scores, and expression of inflammatory genes in chronic active hepatitis C adult patients who are unresponsive or intolerant to therapy with interferon-alpha (IFN-alpha) alone or in combination with ribavirin ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon . In pilot studies, MACROKINE(R) (WF10) has downregulated elevated levels of pro-inflammatory genes (i.e., TNF-alpha, IL-1 beta, MIP-1 alpha) in a dose-dependent fashion, which was associated with clinical benefit.
MACROKINE(R) (WF10) causes direct effects on the body's macrophages, immune cells that both directly fight bacterial and fungal infections as well as direct lymphocytes, such as T cells, to appropriately fight viral diseases. Earlier preclinical and clinical studies of MACROKINE(R) (WF10) in patients with HIV disease suggested that MACROKINE(R) (WF10) could be helpful in patients with other forms of virus-driven immune abnormalities, such as those seen in patients with HCV disease.
The hepatitis C virus
It includes amongst others:
OXO Chemie AG, in collaboration with Dr. Stefan Meuer, professor of Immunology and director of the Institute of Immunology at the University of Heidelberg, Germany and Dr. Michael McGrath, Professor of Laboratory Medicine at UCSF UCSF University of California at San Francisco and chairman of OXO Chemie's scientific advisory board, has developed a quantitative molecular technique that may allow monitoring of drug-associated immune system changes in peripheral blood. This technique employs polymerase chain reaction polymerase chain reaction (pŏl`ĭmərās') (PCR), laboratory process in which a particular DNA segment from a mixture of DNA chains is rapidly replicated, producing a large, readily analyzed sample of a piece of DNA; the process is (PCR PCR polymerase chain reaction.
polymerase chain reaction
Polymerase chain reaction (PCR) ) quantitation of immune activation/disease- associated genes from very small samples of blood obtained from patients.
The HCV Phase 2 trials will be the first to employ this new technology for evaluation of gene expression response in conjunction with clinical response to MACROKINE(R) (WF10). Dr. Meuer stated, "Through real-time evaluation of gene expression changes in response to MACROKINE(R) (WF10), we hope to develop a rationale for use of immune-active drugs in patients with diseases of chronic immunologic activation, such as HCV disease."
Dr. McGrath added, "The results of the MACROKINE(R) (WF10) trial in HCV disease are predicted by the balanced macrophage activation hypothesis. Interference with a cell function that is chronically driving a process leading to a pathogenic outcome should result in resolution of the problem. In the case of HCV disease, macrophage activation drives the chronic T cell activation that over time leads to destruction of the liver. The consistent effect of MACROKINE(R) (WF10) in vitro and in earlier in vivo studies suggests that MACROKINE(R) (WF10) blocks (downregulates) the macrophage-associated T cell activation stimulus, and this should lead to a resolution in part to disease of inappropriate immune activation, such as HCV disease."
OXO Chemie, one of the founding companies of the Heidelberg Technology Park, has offices in South San Francisco (California, USA), Fribourg (Switzerland) and Bangkok (Thailand). The company maintains production facilities in Wanzleben, Germany. OXO Chemie is a pioneer developer of chlorite-based drugs.
The company's lead drug, WF10, is approved for use in Thailand under the name IMMUNOKINE(TM), in patients with postradiation chronic inflammatory diseases including cystitis, proctitis Proctitis Definition
Proctitis is an inflammation of the rectum.
Proctitis affects mainly adolescents and adults. It is most common in men around age 30. Proctitis is caused by several different sexually transmitted diseases. and mucositis. A Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of WF10 is underway in the US and Canada in patients with advanced HIV disease; patient enrollment is nearing completion. The company also has ongoing trials in cancer and hepatitis C.
Additional information on OXO Chemie can be found on the World Wide Web at www.oxochemie.com. WARNING: The information contained herein this press release contains forward-looking statements. The company's activities and actual results may differ significantly from possible results. Based on current expectations, the company assumes no obligation to update this information.
For further information, call (650)246-2215.