Ipsat Therapies commences patient recruitment in Phase IIb
(firmenpresse) - Helsinki, 4 December 2006: Ipsat Therapies Ltd ('Ipsat') today
announces that it has recruited its first patient in a Phase IIb clinical study of its lead product P1A. The study, which is multi-centre, randomized, placebo controlled and double blinded, will further evaluate the safety and efficacy of P1A administered in combination with Ampicillin in preventing the damage to the intestinal microflora caused by the residual beta-lactam antibiotic in hospitalized patients with upper- and lower respiratory tract infections. In the previous studies performed, P1A prevented the emergence of bacterial antibiotic resistance and depletion of healthy intestinal microflora, side effects commonly associated with antibiotic treatment. An excellent safety profile was also demonstrated in all patients treated with P1A.
In this study, the overgrowth of the intestinal microflora with pathogens as a consequence of microflora disturbance by administration of Ampicillin will be monitored.
About two million patients a year become infected while being treated for another illness or injury and over 90 000 die because of these infections. According to the CDC (Center for Disease Control and Prevention), 1.8 million of the infections occur in hospitals, almost 100 000 occur in long-term care centers and about 340 000 occur in home health care. Only the hospital costs of treating hospital infections is estimated to exceed 35 billion USD.
The study will be carried out in 10 centers in Russia and the Ukraine. It is comprised of 2 arms with 50 patients each, one receiving the beta-lactam antibiotic alone, the other receiving the beta-lactam antibiotic and Ipsat P1A. Ipsat expects that the clinical treatment phase of this trial will be completed by end of May 2007.
For further details please contact:
Nora Kaarela, CEO
Ipsat Therapies Ltd
Viikinkaari 4
FIN-00790 Helsinki
Finland
Tel: +358 400 897 020(mobile)
Tel: +358 9 319 36 500 (office)
www.ipsat-ther.com
Notes to editors:
Ipsat Therapies
Ipsat Therapies Ltd is a private company focusing on the development of products in the anti-infective field. Ipsat´s focus is primarily on the development of products for the prevention of antibiotic resistance, antibiotic-associated diarrhea and hospital associated infections. The Company became operational in 1999 and has raised €22 million in funding to date. For more information please visit http://www.ipsat-ther.com.
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Datum: 06.12.2006 - 05:50 Uhr
Sprache: Deutsch
News-ID 87
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contact information:
Contact person: Nora Kaarela
Town:
Helsinki
Phone: +358 9 319 36 500
Kategorie:
Pharmaceuticals & Biotech
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