BASEL, Switzerland, Dec. 19, 2006 (PRIME NEWSWIRE) -- Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today the opening of two primary-treatment phase III clinical trials for isavuconazole (BAL8557) in patients with invasive systemic fungal infections caused by yeasts and molds. Isavuconazole is Basilea's third compound to enter phase III development.
The global trial program for isavuconazole (BAL8557) focuses on patients with invasive candidiasis including candidemia and patients with proven or probable aspergillosis. The program targets two very significant patient groups with high medical need -- hematological cancer patients requiring broad coverage for yeast and mold infections and patients in the intensive care unit setting needing effective treatment of primarily yeast infection. The ability to switch from an intravenous to an once daily oral dosage form provides clinicians with maximum flexibility in using isavuconazole to treat these seriously ill patients. Isavuconazole was granted fast-track designation by the U.S. Food and Drug Administration (FDA).
Isavuconazole is designed to treat invasive life-threatening fungal infections, and is the third of Basilea's development compounds to reach phase III pivotal trials. Basilea's two other investigational drugs currently in phase III are ceftobiprole, the anti-MRSA cephalosporin with broad-spectrum activity, and alitretinoin the first systemic treatment to be developed specifically for Chronic Hand Dermatitis.
"This phase III program consolidates our position in the biotechnology sector and gives us yet another opportunity to bring an important new drug to patients. We now have three compounds in phase III all of which will contribute to our goal of becoming a fully-integrated hospital and specialty company," commented Dr. Anthony Man, Basilea's CEO.
Clinical Trial Design
The first protocol is a phase III, double-blind, randomized study to evaluate the safety and efficacy of isavuconazole (BAL8557) versus voriconazole for the primary treatment of invasive fungal disease caused by aspergillus species or other filamentous fungi. This is the first prospective double-blind study in the primary treatment of aspergillosis ever performed.
The second protocol is a phase III, double-blind randomized study of isavuconazole versus a candin-based regimen in the treatment of candidemia and other invasive candida infections. This trial will also include mild to moderate renally impaired patients that currently have limited treatment options.
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 infection 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 therapy, most importantly the gaps in the antifungal spectrum, unwanted side effects, dosing flexibility as well as the development of resistance.
About Isavuconazole
Isavuconazole has a potent and broad spectrum of activity against both yeasts and molds. This new triazole is developed as a water-soluble pro-drug to allow safe and simple intravenous administration without contraindication in renally impaired patients. In addition, taken as convenient once daily or once weekly capsules, the prodrug results in rapid and almost complete absorption and distribution to infected tissues.
Basilea successfully completed its 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. Clinical drug interaction studies illustrated attractive pharmacokinetic features and the potential for less drug-drug interactions than a number of broad-spectrum antifungal drugs in current use.
About Basilea
Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX:BSLN). 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 and specialty care setting. The company owns a diversified product portfolio including three products in phase III clinical development for severe medical indications. Basilea is building a sustainable hospital and specialty biopharmaceutical business. The company is integrating commercialization into its organization, in a first step through co-promoting ceftobiprole.
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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