OctoPlus Proves Efficacy Of OP-145 In Phase II Ear Infection Study

Main Category: Ear, Nose and Throat
Also Included In: Clinical Trials / Drug Trials
Article Date: 29 Jul 2008 - 4:00 PDT

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OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO), the drug delivery and development company, announces today that efficacy of OP-145, a novel therapy for the treatment of chronic middle ear infection (otitis media), was demonstrated in an interim analysis of the Phase II study. As a result, OctoPlus will close the study because its goal has been achieved.

An independent Data and Safety Monitoring Board (DSMB) completed a formal interim analysis of safety and efficacy data from the Phase II study. This interim analysis shows that treatment with OP-145 is safe and effective, with statistically significant improvement of otoscopic scores. As a result, the DSMB advised OctoPlus to close the study because clinical endpoints were achieved. OctoPlus will follow the recommendation of the Board and close the study at this stage. Complete and final study results are expected to be available by the end of 2008.

Based on these positive results, OctoPlus will proceed with preparations for further development of OP-145 and continue to find commercial partners. In November 2006, OctoPlus granted Green Cross Corporation, a leading pharmaceutical company in the Republic of Korea, an exclusive license to develop and market OP-145 for the Korean market.

The double-blind Phase II clinical trial was started in 2006 and comprises a randomised placebo-controlled study in a maximum of 52 patients suffering from chronic suppurative otitis media, with the option to end the study if interim results were statistically significant. The clinical endpoints of the study were safety and efficacy measured by improvement of otoscopic scores. The interim evaluation was executed as planned in the study protocol, and is based on data from 30 patients, which represents more than half of the planned total patient study group.

"We are very pleased to have obtained proof of efficacy for OP-145," said Joost Holthuis, CEO of OctoPlus. "This further builds the product profile of OP-145 as a new approach in the treatment of infections and puts us in an excellent position to secure a global commercial partner for this product."

About OP-145

OP-145 is a novel peptide product that offers potential benefits to patients with chronic otitis media that do not respond to currently available antibiotics. In addition to chronic middle ear infection, OP-145 shows potential for other indications such as sinusitis and chronic bronchitis.

About OctoPlus

OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled-release versions of known protein therapeutics, other drugs, and vaccines.

Our pipeline consists of 5 products in pre-clinical and clinical development. Our lead product is Locteron, a controlled release formulation of interferon alfa for the treatment of chronic hepatitis C, which we are co-developing with Biolex Therapeutics. Locteron is currently in Phase II clinical studies. Furthermore, our pipeline comprises a product candidate for the treatment of chronic middle ear infection, which has completed Phase II clinical proof of concept testing, a pre-clinical GLP-1 analogue product candidate for the treatment of diabetes and two pre-clinical-stage single-shot vaccines.

In addition, OctoPlus is a European leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult to formulate active pharmaceutical ingredients. The earnings and expertise that we derive from rendering formulation and manufacturing services help to support our own drug development programs.

OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit our website http://www.octoplus.nl.

This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus N.V. and the industry in which it operates. These statements are based on OctoPlus N.V.'s current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", "will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.

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