News

EmboCept® a milestone in the development of DSM

DSM-TACE (Degradable Starch Microspheres) became part of the CIRSE treatment guidelines for Hepatic Transarterial Chemoembolisation!

This is a great success for the development of DSM over the past almost 40 years, a great success for PharmaCept and a breakthrough for the treatment of patients with liver cancer, especially with HCC.

Pharmacia (Sweden) was the first company to begin developing DSM. In the late 80s Spherex® was the first degradable starch microsphere product in the world to be registered. This was based on thorough pre-clinical testing, showing e.g. the significant increase of drug accumulation in liver and lung tumors in comparison to pure IA-administration — up to 1000 times higher than under IV (1)!

One of the most important achievements of this time was the understanding gained on the development of collateral tumor vessels under repeated ischemias for more than 3–4 hours, which could avoided by the use of DSM (2).

In addition to this, Spherex was also the first registered embolic material to be tested under randomized conditions against the IA-infusion of doxorubicin in HCC-patients. This was not only the first randomized study in TACE, but also the first (and only one until today) with a significantly improved response rate and (!) survival (3).

After the termination of production by the new owner of the Swedish company, PharmaCept started developing a new DSM – EmboCept® with an increased degradation time. Over the past few years, several pre-clinical and clinical studies were conducted and published. Colleagues from Homburg and Göttingen were able to show in an animal model that 2 hours of ischemia by DSM leads to the same necrosis rates as DEB and significant better necrosis rates than lipoiodol (4). A recently published study by a group of European scientists showed an excellent performance of our starch microspheres and a very good tolerability, which also enables out-patient therapy procedures (5).

Last, but not least, with EmboCept® S DSM 50 µm we can offer the best ever calibrated starch microspheres (95 % within 20–90 µm) with a dedicated half-life degradation time of 30–40 min and flexible in the combination with active drugs.

Degradable starch microspheres avoiding/reducing VEGF-release (6), reaching comparable necrosis rates like permanent materials, but with a much better tolerance level and high efficacy especially in late stage liver and lung cancer patients.

Finally, I would like to thank at least a few colleagues and friends personally for their support as representatives of a worldwide group of scientists who support and utilise the idea of DSM:

Thomas Vogl (Frankfurt), Christiane Kuhl (Aachen), Roberto Iezzi (Rome), Boris Guiu (Montpellier), Thierry de Baere (Paris), Katarina Malagari (Athens), Bora Peynircioglu (Ankara), Jafar Golzarian (Minneapolis), Alex Tang (Kuala Lumpur).

Dr. Jürgen Ebert
CEO PharmaCept

References:

• Pohlen, U. et al. Anticancer Res 31: 147–52 (2011) – concerns Spherex
• Persson, B.G. et al. World J Surg 11: 672–7 (1987) – concerns Spherex
• Taguchi, T. Reg Cancer Treat 3–4: 117–20 (1992) – concerns Spherex
• Ziemann, C. et al. BMC Cancer 19: 938 (2019) – concerns EmboCept® S
• Ludwig, J.M. et al. Cancers 13, 5122 (2021) – concerns EmboCept® S
• Schicho, A. et al. J of Clin and Transl Hepatology 4: 288–292 (2016) ) – concerns EmboCept® S

PharmaCept hosts an online sympoisum dealing with “Chemoembolisation with degradable starch microspheres (DSM): experience in liver and lung tumors” on Monday, September 14, 2020, from 13:00 — 14:00

Program

Safety and efficacy of DSM-TACE in unresectable HCC-patients: The Essen experience within a multicentre study
Speaker: Jens Theysohn, University Hospital Essen, Germany

DSM-TACE case reports: late HCC and ovarian metastases
Speaker: Roberto Iezzi, University Hospital Rome, Italy

DSM-TACE for the treatment of colorectal liver metastases
Speaker: Alex Tang, Subang Jaya Medical Centre (SJMC), Kuala Lumpur, Malaysia

DSM-TACE for transpulmonary chemoembolization in lung tumors
Speaker: Thomas Vogl, University Hospital Frankfurt, Germany