BASEL, Switzerland, Dec. 20, 2005 (PRIMEZONE) -- Basilea Pharmaceutica Ltd. (SWX:BSLN) presents positive phase II clinical trial data on its water-soluble azole BAL8557 in a late-breaker abstract at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington D.C. Six additional posters confirm its excellent potency against fluconazole-resistant yeasts and its promising activity against difficult-to-treat molds.
"Data presented at ICAAC clearly support our anti-fungal's potential to treat serious infections including those due to resistant yeasts and molds, an area of growing medical need," commented Dr. Rienk Pypstra, Chief Development Officer of Basilea.
In a late-breaker poster (LB2-32), Dr. Markus Heep of Basilea presents details of the positive phase II trial in patients with esophageal candidiasis with excellent and sustained clinical cure rates for both the once weekly and the daily dosing regimens. At all dosing regimens BAL8557 was well tolerated and appeared to have a good safety profile.
In addition to the clinical evidence of activity against mucosal Candida infections, Warn shows that Basilea's novel anti-fungal BAL8557 is highly effective in a mouse model of disseminated candidiasis (B-47). Warn (M-1620) and Mouton (M-1621) present the potent activity of this water-soluble azole against fluconazole-resistant Candida species. Impressive anti-fungal activity in a mouse model of a difficult-to-treat disseminated Aspergillus infection is also presented by Warn (B-48). Mouton (M-1622) and Ghannoum (M-1623) describe new evidence for the broad-spectrum activity of BAL8557. The compound demonstrates potent activity against fungi causing skin infections, including terbinafine-resistant T. rubrum isolates, and against difficult to treat zygomycetes.
"The posters at this year's conference highlight Basilea's position as a leader in anti-microbial research, generating drugs with strong competitive profiles," commented Prof. Jutta Heim, Chief Scientific Officer of Basilea.
The need for new anti-fungal 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 anti-fungal 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 anti-fungal spectrum, unwanted side effects, dosing flexibility as well as the development of resistance.
New scientific data on BAL8557 at ICAAC 2005
Friday, 16 December 2005
B-47
Dose Response Curves and Dose Fractionation Studies with BAL8557 in a Murine Model of Disseminated Candidiasis P. A. WARN, A. SHARP, D. W. DENNING; Univ. of Manchester, Manchester, United Kingdom.
B-48
In Vivo Efficacy of the Triazole BAL8557 (BAL) Compared to Voriconazole (VOR), Itraconazole (ITC) and Caspofungin (CAS) by a New qPCR and Quantitative Culture in Neutropenic Murine Model of Aspergillus flavus P. A. WARN, J. MOSQUERA, A. SHARP, D. W. DENNING; Univ. of Manchester, Manchester, United Kingdom.
Saturday, 17 December 2005
Late Breaker 2-32
Efficacy, Safety and Tolerability of Three Different Dosing Regimens of BAL8557 vs Fluconazole in a Double-Blind, Randomized, Multicenter Trial for the Treatment of Esophageal Candidiasis (EC) in Immunocompromised Adults J. VILJOEN1, I. MITHA2, M. HEEP3, M. GHANNOUM4; 1 Glenclin Corporation Bloemfontein RSA, 2 Benmed/ Pentagon Hospital, Benomi RSA, 3 Basilea Pharmaceutica, Basel, Switzerland, 4 Case Western Reserve Univ., Cleveland, OH.
Sunday, 18 December 2005
M-1620
In Vitro Activity of a New Triazole BAL4815 against Candida Isolates with Decreased Fluconazole Susceptibility P. WARN1, D. DENNING 1, M. HEEP 2, N. ISHAM 3, M. GHANNOUM 3; 1Univ. of Manchester, Hope Hosp., Manchester, United Kingdom, 2Basilea Pharmaceutica, Basel, Switzerland, 3Case Western Reserve Univ., Cleveland, OH.
M-1621
In Vitro Activity of the New Azole BAL4815 against Clinical Candida Isolates Comprising Resistant C. albicans and Less Susceptible Candida spp BREUKER 1, J. F. MEIS 1, P. E. VERWEIJ 2,3, J. W. MOUTON1; 1Canisius Wilhelmina Hosp., Nijmegen, The Netherlands, 2RUNMC, Nijmegen, The Netherlands, 3NUCI, Nijmegen, The Netherlands.
M-1622
In Vitro Activity of the New Azole BAL4815 against Clinical Dermatophyte Isolates BREUKER 1, J. F. MEIS 1, P. E. VERWEIJ 2,3, J. W. MOUTON1; 1Canisius Wilhelmina Hosp., Nijmegen, The Netherlands, 2RUMNC, Nijmegen, The Netherlands, 3NUCI, Nijmegen, The Netherlands.
M-1623
Antifungal Activity of BAL4815, a Novel Azole against Dermatophytes and Emerging Non-Dermatophyte Fungi Including Zygomycetes M. A. GHANNOUM, N. ISHAM; Case Western Reserve Univ., Cleveland, OH.
Positive BAL8557 Phase II Results
In September this year Basilea released positive phase II results on BAL8557. The phase II study compared three dosing regimens of BAL8557 to fluconazole in the treatment of esophageal candidiasis to demonstrate antifungal efficacy in patients. All three BAL8557 dosing regimens were highly effective for the stringent primary endpoint of endoscopically confirmed complete clinical cure. Endoscopically confirmed clinical cure at the end of therapy was achieved in 95%, 95% and 98% of patients treated with BAL8557 for the 100 mg daily, 50 mg daily and 400 mg weekly doses, respectively, and in 95% of patients treated with 100 mg fluconazole. Statistical non-inferiority to comparator was confirmed for all three BAL8557 dosing regimens. Excellent activity was also confirmed in secondary endpoints, including microbiological cure, therapeutic responses and follow-up assessments at two and four weeks. In the trial, BAL8557 was safe and well tolerated with an adverse event profile comparable to fluconazole. Planned phase III trials will target severe invasive yeast (Candida) and mold infections (including Aspergillus and Zygomycetes).
About Basilea
Basilea Pharmaceutica Ltd. (SWX:BSLN) is a biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea was founded in October 2000 to discover, develop and bring innovative medicines to the market. The company's fully integrated research and development operations are currently focused on new anti-bacterial and anti-fungal agents to fight drug resistance as well as on dermatology drugs.
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The press release can be downloaded from www.basilea.com