Customised DSM are currently used in commercial products for surgical hemostasis; for arterial occlusion in liver cancer therapy, and as an enzymatic test kit.
Characteristics
Through a precision-engineered process, the spherical microporous particles of DSM are produced from plant starch. Parameters like size, charge, porosity and in-vivo degradation times can be tailored to meet different therapeutic needs.
Mode of action
Magle's DSM-A material is capable of accelerating natural hemostasis. It is marketed by Medafor, Inc under the tradename Arista®. Creating an osmotic pressure, the particles concentrate platelets and other blood constituents on their surfaces and as the blood becomes
dehydrated, the hemostatic cascade kicks in. Magle's DSM-S is used as an adjuvant in the treatment of liver cancer. It is marketed in Japan by Pfizer/Yakult under the tradename Spherex® whereas Magle holds global rights outside Japan. Put to work, a sterile DSM-S suspension is co-injected with the cytostatic drug in the hepatic artery, where the microspheres cause a temporary arterial occlusion and a high local concentration of the drug. The degradation of the DSM-S particles (forming glucose) starts immediately and full resorption is reached within 60 minutes, completely restoring blood flow.
Therapeutic advantages
DSM is a based on plant starch material that is completely enzymatically degraded by the action of the body's amylases. This makes DSM a safe and versatile material, which is easy to register as a medical device or as a carrier of active agents.
Stage of development
DSM is commercially available for various clinical applications including hemostasis and chemoembolisation under the brand names Arista and Spherex respectively. Through development initiatives currently ongoing at our facility in Kristianstad, new ideas are being turned into tomorrow's DSM products. Information about these projects and partners is not disclosed.
Regulatory status
DSM in its currently available commercial forms are registered medical devices. Arista® is registered by the FDA, for CE mark in Europe and by the Japanese FDA.
Manufacturing
Pilot- and small scale production of finished DSM products is performed at our GMP and ISO 13485 approved facility in Kristianstad, Sweden.
Commercial scale DSM is manufactured under GMP conditions at our FDA approved sister company in Denmark.
Future development
Potential areas where DSM opportunities can be turned into commercial value are f.ex. for controlled release. Modifying degradation time, onset and duration can be adjusted from minutes to weeks. The material lends itself well to varying administration routes, such as nasal, buccal or parenteral. DSM has very good stability in wet and dry formulations and its resistant to degradation by heat or radiation.
Research and development ideas
We are always on the look-out for new partnerships to develop new products. We welcome unsolicited development ideas from the corporate and academic world and strive to build mutually beneficial long-term partnerships. Please feel free to contact us. Our R&D team comprises pharmacists, microbiologists and chemical engineers working with state of the art laboratory and process equipment.
