BASEL, Switzerland, Sept. 29, 2006 (PRIMEZONE) -- Data presented at ICAAC further support phase III development program scheduled to start by year-end in invasive candida (yeast) and aspergillus (mold) infections.
The positive phase II and drug-drug interaction study results released earlier showed the potential of BAL8557 for more convenient dosing schedules and less drug-drug interactions than a number of antifungal drugs in current use. "Data presented at ICAAC further support BAL8557's clinical development in severe invasive candida and aspergillus infections. Phase III is scheduled to start by year-end," stated Rienk Pypstra, MD, Chief Development Officer at Basilea. BAL8557 was recently granted fast-track designation by the U.S. Food and Drug Administration (FDA).
At this year's Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) conference in San Francisco, CA, several posters addressed the favourable activity profile of Basilea's azole antifungal agent BAL8557 compared to other broad-spectrum antifungals.
Potent in vitro activity of BAL4815, the active principle of BAL8557, was shown against Candida blood-stream isolates including fluconazole-resistant strains (M-1589). BAL4815 showed the lowest minimal inhibitory concentrations (MIC50 and MIC90) and therefore the highest potency of all tested azoles in a representative clinical sample of about 300 candida blood stream isolates.
Exophiala dermatitidis, an opportunistic pathogen known to cause brain abscesses, was susceptible to newer azoles including BAL4815 (M-1588). Cryptococcus neoformans, a candin-resistant pathogenic yeast also proved highly susceptible to BAL4815 (M-1587).
Quality control strains of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) were evaluated in a pilot study. Test results of BAL4815 for yeasts and molds confirmed the good aspergillus activity, were highly reproducible and provide for a good basis for developing standardized susceptibility testing (M-1571). In a new mouse model of systemic Aspergillus fumigatus infection -- the most relevant agent of invasive aspergillosis in man -- BAL8557 was highly effective in reducing the kidney burden in mice with disseminated disease (A-1120).
About BAL8557
BAL8557 is a pro-drug suitable for simple intravenous administration and its excellent oral absorption allows a convenient once daily or even once weekly dosing, supporting patient-tailored treatment schemes. Basilea successfully completed its key phase II trial with both high clinical cures rates and a safety profile comparable to gold standard therapy but with potentially a more flexible dosing schedule. A series of clinical drug interaction studies presented at the International Society for Human and Animal Mycology (ISHAM) meeting earlier this year illustrated the attractive pharmacokinetic features and the potential for less drug-drug interactions of BAL8557. Phase III studies for the treatment of invasive candidemia and aspergillosis including rare molds are scheduled to start by year-end.
The Need for New Antifungal Therapies
The expansion of the immunocompromised patient population including cancer patients with chemotherapy induced neutropenia, transplant recipients receiving immunosuppressive therapy and HIV infected patients has led to an increased incidence of invasive fungal infections. In major markets alone, an estimated nine million patients are at risk for invasive fungal infections with more than two million patients treated.
Currently available antifungal drugs are reported to fail in more than 50% of patients with acute invasive aspergillosis and in 20-30% of patients with candidemia. There is a high medical need to address the limitations of current therapies, most importantly the gaps in the antifungal spectrum, unwanted side effects, early adequate dosing as well as the development of resistance.
About Basilea
Basilea Pharmaceutica Ltd. (SWX:BSLN) is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea's fully integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance and on the development of dermatology drugs. Basilea's products are targeted to satisfy high medical and patient needs in the hospital setting. The company owns a diversified product portfolio including three products for severe medical indications in late stages of clinical development.
Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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