By Kwame Mensah --
Earlier this month, Antisense Pharma, GmbH, a biopharmaceutical company located in Regensburg, Germany, announced the issuance of U.S. Patent No. 7,963,956, entitled "Portable equipment for administration of fluids into tissues and tumors by convection enhanced delivery technique," which is directed to Convection Enhanced Delivery (CED). CED is being touted as an application system for long-term and outpatient administration of therapeutic substances into brain tissue. The portable system was specially developed for the treatment of brain tumor patients using Antisense Pharma's drug Trabedersen. Patents in Europe, Canada, Japan, and India, with additional patents being pursed worldwide, also cover CED.
Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer of Antisense Pharma, stated that CED provides a solution to "[t]he difficulty of administering a therapeutic dose of a pharmacologically effective substance into the brain tissue due to the very small number of substances capable to pass the blood-brain barrier." Dr. Schlingensiepen further stated that this difficulty "is one of the main reasons for the currently very few therapy options we can offer to brain tumor patients." Antisense Pharma explains that CED uses a special infusion technology that provides a high and uniform concentration of active substances in the brain tissue -- even at a distance from the place of infusion. The company explains further, that the substance is administered directly into the tumor or the surrounding brain tissue using a permanent, pressure-supported infusion using a special catheter/pump system. It concludes that since CED builds up a pressure gradient, a clearly higher and more homogeneous penetration volume can be achieved compared to conventional diffusion.
Dr. Hubert Heinrichs, Chief Medical Officer at Antisense Pharma, explains that with the development of the first portable, and now patented CED application system, "[t]he option of a CED-based treatment using a portable application system over weeks and months could well stimulate the development of urgently required neurotherapeutics."
The CED consists of several harmonized components. After the catheter has been stereotactically placed in the tumor, the drug is administered via an infusion line using an external, programmable, portable pump. The implantation of the catheter is a neurosurgical intervention, which is geared to the placement of a shunt for hydrocephalus patients where excessive brain liquid is diverted into the blood circulation. The brain catheter is inserted through the skin to a port chamber, which is usually placed in the chest muscle. The chamber is then connected to an external infusion line, which in turn is connected to a small, portable infusion pump that can easily be attached to the belt. Dr. Schlingensiepen summarizes that:
Using this application system, we are able to administer highly effective drugs, by-passing the blood-brain barrier. At the same time, we allow patients to continue living their normal lives during the therapy: once the catheter system has been positioned, no extensive hospitalization is required. The total 5-month treatment using Trabedersen provides patients with maximum mobility and quality of life.
Key claims encompass the CED apparatus itself and a method of use for the apparatus to treat a number of cancer tumors.
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