LEIDEN, The Netherlands, March 7 /PRNewswire/ -- OctoPlus, the drug delivery and development company, announced today that it has successfully completed a safety and tolerability study with OP-145 in patients with chronic otitis media (chronic middle ear infection) and has commenced a Phase II clinical trial.
OP-145 is a novel peptide product that has a unique mechanism of action. It neutralizes the bacterial toxins that often keep chronic middle ear infections active. OP-145 offers potential benefits to patients with chronic otitis media that do not respond to currently available antibiotics and thereby require surgical intervention. Middle ear infections are a very common condition, especially in young children but also in adults, and cause a severe morbidity burden. In addition to chronic middle ear infection, OP-145 shows potential for other indications such as sinusitis and chronic bronchitis.
OP-145 is a co-development project between OctoPlus and Leiden University Medical Center.
Phase I results
The Phase I safety and tolerability study comprised a dose-ranging assessment in 16 therapy-resistant patients, which did not respond to antibiotic treatment and had an average disease duration of 17 years. Results show that the product is safe and was well tolerated. In addition, 12 out of 16 patients also showed either full recovery or significant improvement after the 2-week therapy, which gives a promising early indication of the efficacy of OP-145.
With the results of the Phase I study OctoPlus has gained approval to start a multicenter Phase II clinical trial.
Phase II design
The Phase II trial will comprise a double blind, placebo-controlled study in 52 patients, with the option to end the trial after treatment of 26 patients if interim results are statistically significant. The clinical endpoints of the study are safety and therapeutic efficacy. The Phase II study will be carried out in 3 clinical centers in the Netherlands.
Dr Joost Holthuis, Chief Executive Officer of OctoPlus, said:
“These are very encouraging results for OP-145 proving that our product is not only safe and well-tolerated but also showing extremely promising signs for its efficacy. These results have also allowed us to begin Phase II clinical trials immediately, enabling us to stay on track to complete the study in Q1 2007.”
About OctoPlus
OctoPlus is a product-oriented drug delivery company that focuses on the development of innovative drug delivery systems to build a pipeline of product candidates. OctoPlus is also an internationally established provider of pharmaceutical development services and GMP manufacturing for pharmaceutical and biotechnology companies. The company is located in Leiden, the Netherlands.
OctoPlus was founded in 1995 and currently employs more than 120 people. In January 2005 the company raised EUR 18 million in a second financing round from an international group of investors: Life Sciences Partners II B.V. (Amsterdam, the Netherlands), S.R. One, Ltd. (West Conshohocken, PA, USA), Innoven Partenaires (Paris, France), Fortis Private Equity (Brussels, Belgium) and SurModics, Inc. (Minneapolis, MN, USA).
Website: www.octoplus.nl
Octoplus BV
CONTACT: For further information please contact: OctoPlus, Dr. JoostHolthuis, Chief Executive Officer, Tel : +31-(0)-71-5244044, Email:octoplus@octoplus.nl, Financial Dynamics, Julia Philips, John Gilbert, Tel:+44-(0)-207-269-7169
