PARI Pharma Completes Successful Clinical Trials for Tobramycin 100 & Investigational eF...(d to see similar lung deposition and saf...),Health

Date:11/10/2008

d to see similar lung deposition and safety profiles while using a lower dose and volume of tobramycin," said Dr. Allan Coates, lead researcher from the Hospital for Sick Kids in Toronto, Canada. "Technology is really working on the side of the patient with this formulation and the resulting reductions in treatment times. Lack of patient adherence to recommended therapy is a major challenge in cystic fibrosis, especially in adolescents, with the length of treatment time given as the major excuse. With equivalent delivery but in a much shorter time, there are improved chances for greater adherence to prescribed therapy."

Based on the successful results of the Phase I and Phase II clinical trials, regulatory bodies in Europe welcomed the advantages and benefit of PARI Tobramycin 100 for CF patients and recommended moving forward with a Phase III study to demonstrate therapeutic efficacy and equivalence to TOBI.

PARI Pharma is currently in discussions with multinational pharmaceutical companies to evaluate the efficacy of PARI Tobramycin 100 in a Phase III clinical study and to ultimately make this next-generation treatment available to CF patients worldwide.

The Phase I clinical trial was a randomized, open label, crossover, single-dose deposition study of PARI Tobramycin 100 in an Investigational eFlow versus TOBI/LC PLUS in 16 cystic fibrosis patients, including 8 adults and 8 children. The study was conducted by Dr. Allan Coates at the Hospital for Sick Kids in Toronto, Canada. Tobramycin lung deposition for both applications was between 46mg and 47mg. There was also no difference in the ratio of peripheral to central lung deposition between both drug products and delivery systems. Results from the study were presented at the North American Cystic Fibrosis Conference in October.

The Phase II clinical trial, a randomized, open label, parallel group, non-inferiority, 28-day pharmacokinetic study evaluated the serum levels after twice daily
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