BERLIN, Oct. 25 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today reported results of a new clinical study demonstrating that its investigational antifungal agent NOXAFIL(R) (posaconazole) Oral Suspension, compared to fluconazole, significantly reduced the incidence of aspergillosis, a serious fungal infection associated with a high rate of mortality, as well as serious invasive fungal infections (IFIs) overall during treatment, in allogeneic hematopoietic stem cell transplant (HSCT) recipients(1) with graft-versus-host disease (GVHD)(2). In this patient population, NOXAFIL decreased deaths due to IFIs compared to fluconazole, while demonstrating a similar safety profile. Both drugs were well tolerated in this study.
The results of this study, the first randomized, double-blind, controlled long-term study of antifungal prophylaxis (preventive treatment) in HSCT recipients with severe GVHD, were presented for the first time at the Trends in Medical Mycology (TIMM 2005) meeting in Berlin.
In clinical studies, NOXAFIL has demonstrated broad-spectrum activity covering both yeasts (such as Candida) and moulds (such as Aspergillus) responsible for serious invasive fungal infections. Invasive fungal infections are a leading cause of death in HSCT recipients, with mortality rates varying between 60 and 90 percent(3).
"There is an urgent need to prevent serious invasive fungal infections in patients, including infections that are resistant to other therapies or caused by emerging pathogens that can be difficult to diagnose and treat," said lead study investigator Andrew J. Ullmann, M.D., attending physician for infectious diseases and hematology/oncology, Medical Hospital and Healthcare Center of Johannes Gutenberg University, Mainz, Germany. "The results of this study demonstrate that NOXAFIL may be an option for long-term preventive treatment, allowing these seriously ill patients to recover."
Allogeneic HSCT recipients are at high risk for IFIs for several reasons including sustained immunosuppressive therapy due to risk associated with donor compatibility and transplant complications that include prolonged neutropenia, graft failure and graft-versus-host disease (GVHD)(4). The incidence of IFIs in HSCT recipients is increasing, with aspergillosis becoming increasingly more common in these patients(5).
Clinical Study Results
In this large, prospective, double-blind, double-dummy, controlled study, a total of 600 patients from 90 centers worldwide were randomized to receive NOXAFIL Oral Suspension 200 mg three times daily (n=301) or fluconazole 400 mg capsules once daily (n=299) for a maximum of 112 days (16 weeks) or until a protocol specified endpoint was reached (breakthrough IFI, adverse event requiring discontinuation, or death due to underlying disease or GVHD). All patients were monitored for fungal infection during the 112-day treatment phase and were followed for two months after completing treatment or after prematurely discontinuing therapy. An independent data review committee adjudicated proven/probable IFIs using the EORTC/MSG(6) criteria(7).
In the study, NOXAFIL compared to fluconazole significantly reduced the incidence of aspergillosis (3 vs. 17, p=.001) as well as invasive fungal infections overall (7 vs. 22; p=.004) in patients while on treatment (defined as first dose to seven days after the last dose). NOXAFIL also significantly reduced the incidence of aspergillosis (7 vs. 21; p=.006) compared to fluconazole and was as effective as fluconazole in preventing IFIs overall (16 vs. 27; p=.074) during the 112-day study-specified primary time period. NOXAFIL significantly delayed the onset of IFIs in this patient population compared to fluconazole, as measured by mean days from first dose to onset of IFI while on treatment (102 vs. 88 days; p=.048). In the study, NOXAFIL reduced the number of deaths attributed to IFI compared to fluconazole (4 vs. 12; p=.041). The rate of all-cause mortality was similar in the two treatment groups.
The incidence of treatment-related and serious adverse events in the study were similar for both the NOXAFIL and fluconazole groups, with the overall rate of adverse events and the rate of patient discontinuations being similar. The most common adverse events in both treatment groups were gastrointestinal in nature.
NOXAFIL (posaconazole) Oral Suspension is a novel triazole agent that exhibits potent antifungal activity in vitro against a wide range of fungal pathogens, including both yeasts and moulds. It has been studied as treatment for serious invasive fungal infections in patients with refractory disease (failed prior therapy). Development of NOXAFIL is consistent with Schering- Plough's strategy to broaden its anti-infectives portfolio and is in line with its plans to build strength in its global franchises through both internal research and external licensing opportunities.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's Web site is http://www.schering-plough.com/ .
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the company's strategy and the development of NOXAFIL. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward- looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's second quarter 2005 10-Q.
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