OctoPlus reports first clinical proof of concept with OctoDEX(TM) , a novel controlled release platform for biopharmaceuticals

10-Feb-2004

Leiden. OctoPlus, a drug delivery and development company, presented the first results in humans of its proprietary OctoDEX(TM) delivery platform. In this study, it was shown that controlled release of recombinant human Growth Hormone (hGH) from OctoDEX? Microspheres can be achieved over a period of approximately two weeks while maintaining functional activity of the protein. The preliminary results were presented today at SMi's third annual Controlled Release Conference in London by Dr. Leo de Leede, Managing Director, OctoPlus Technologies B.V.

The clinical study was carried out in 18 male elderly volunteers. After a single injection of hGH in OctoDEX(TM), prolonged serum concentrations of the drug were achieved for two weeks. No burst release was observed at the time of injection. Functional activity of the protein was confirmed during the period of release by increasing levels of two well-established biomarkers for hGH activity (Insuline-like Growth Factor-1 and IGF-binding protein-3). Results from this human study showed strong correlation with data generated previously in animal studies and in laboratory experiments. Material for the human trial was produced in OctoPlus' cGMP manufacturing facility.

The OctoDEX(TM) technology is based on the formation of small particles, so-called microspheres, in which the biopharmaceutical drug is encapsulated in its natural form. After injection under the skin, the microspheres slowly degrade and the native biopharmaceutical is released at a controlled rate for a period of up to several weeks. The OctoDEX(TM) microspheres are composed of fully biodegradable building blocks. The technology is protected worldwide by a large number of issued and pending patents.

OctoDEX(TM) enables development of novel controlled release formulations for established and experimental biopharmaceutical drugs. Controlled release formulations reduce injection frequency and increase patient comfort and compliance. They can also improve safety and efficacy of a drug by avoiding peak concentrations and achieving prolonged high concentrations in target organs and tissues.

Development of a controlled release formulation of recombinant hGH is the first OctoDEX? application in development at OctoPlus. Other potential applications include well-established protein drugs such as granulocyte-colony stimulating factor, interferon alpha and interferon beta. The total market addressed by OctoDEX(TM) is currently well over US$ 20 billion and is rapidly expanding.

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