Product innovations selenium in intensive care medicine
Keyhole Limpet Hemocyanin (KLH) Integrated concept
Interferon therapy D-Galactose

Successful development of Immunocyanin as therapeutic drug product for bladder carcinoma and as novel carrier protein for the development and manufacture of conjugate vaccines

 
Immunocyanin is biosyn’s lead innovative product from its research pipeline. This highly immunogenic protein consists of the purified and standardized subunits of keyhole limpet hemocyanin (KLH). Immunocyanin is prepared from the hemocyanin collected from the sea snails (giant keyhole limpet, Megathura crenulata) living off the California coast. The antigen, immunocyanin, formulated as a lyophilized drug product, IMMUCOTHEL® , is one of the strongest activators of cellular and humoral immunity and reduces the recurrence rate of superficial bladder carcinomas after transurethral resection.

The instillation of hemocyanin into the urinary bladder results in a marked immunostimulation of macrophages associated with the release of cytokines within the bladder mucosa. A specific immune response against remaining tumor cells may be induced by the similarity of the carbohydrate structures bound on the active substance like Thomsen-Friedenreich-antigen, which is frequently expressed on bladder carcinoma cells, too.

The first European country to grant a marketing authorization, in 1997, for IMMUCOTHEL®, was The Netherlands. Marketing application is either pending or is being made in other European countries including Germany, Austria, Italy and France. Marketing plans are being developed for North America, including the USA.

Another formulation of immunocyanin is VACMUNE®, a liquid product, dissolved in water. VACMUNE®, being highly immunogenic, is used as a carrier protein for specific tumor antigens to prepare vaccines.

Since there is an enormous interest in the development of novel immunotherapeutic treatments this product is expected to play an important role as novel therapeutic tool. Therapeutic and preventive vaccines under development in the USA, Canada and Europe are already in phase II and phase III clinical trials. These therapeutic vaccines with VACMUNE® as an active component are being used in patients even of all stages of tumors.

Patent information:
„Verwendung von Hämocyaninen und Arylphorinen zur Beeinflussung des Immunsystems und Behandlung von Tumoren“
  • European Patent-No: 0 320 528
    Granted: 08.09.1993
„Use of hemocyanins and arylphorins to influence the immune system and for the treatment of tumors“
  • Kanada No. 1,336,322
    Granted: 18.07.1995
  • Japan No. 270 91 11
    Granted: 17.10.1997
  • USA No. 5,231,081
    Granted: 27.07.1993
Hemocyanin Products