Isotope Technologies Garching GmbH announces in-licensing of DOTA-Zoledronate for Bone Targeted Radionuclide Theranostics of Osseous Metastase

The ITM Group announced today that its subsidiary ITG GmbH has successfully in-licensed DOTA-Zoledronate, a next generation theranostic agent for Bone Targeted Radionuclide Therapy and Diagnostics in patients suffering from bone metastases. DOTA-Zoledronate specifically targets cancerous bone lesions and, when radiolabeled with therapeutic or diagnostic radioisotopes, has shown high potential for PET-Imaging and Endoradiotherapy. Due to its versatile properties for radiolabeling, DOTA-Zoledronate is a promising agent for the development of other future-oriented radionuclide therapy concepts for personalized nuclear oncology. Fundamental research into radiolabeled DOTA-Zoledronate conjugates has recently been conducted at the Johannes Gutenberg University Mainz led by the head of the Institute of Nuclear Chemistry, Prof. Frank Rösch.

About DOTA-Zoledronate

DOTA-Zoledronate is a DOTA-conjugated bisphosphonic acid indicated for the treatment of bone metastases in patients with serious cancers such as prostate or breast cancer. Its affinity for hydroxyapatite which is a major component of the mineral matrix of the bone makes it preferable for Bone Targeted Radionuclide Imaging and Therapy. In first studies DOTA-Zoledronate showed an outstanding target to background ratio and a fast clearance pathway. Moreover, the novel bone agent is attractive for tagging of various radionuclides like the generator derived PET-radionuclide Gallium-68, therapeutic beta-emitting no-carrier-added (n.c.a) Lutetium-177 as well as the ?-particle emitters Actinium-225 and Bismuth-213.

About therapeutic n.c.a. Lutetium-177

ITM Group’s lead product, n.c.a. Lutetium-177, is a superior therapeutic radionuclide currently undergoing Marketing Authorization procedure. Upon approval by the European Medicines Agency (EMA), which is expected in Q1 2016, the medicinal product will be launched under the brand name EndolucinBeta.

About Bone Metastases

Certain cancers such as breast, prostate, lung, thyroid, and kidney cancers are prone to spread to the bone. In breast and prostate cancer patients in particular, the bone is often the first distant site of cancer spread with more than 2 out of 3 patients developing this secondary disease in the late stage resulting in more than 1.5 Million cases of secondary cancer in bone worldwide. Metastatic spread of the cancer into the bones causes severe bone pain, spinal cord compression and even skeletal fractures thereby tremendously reducing patients’ quality of life.

About the ITM Group

The ITM Group is a privately held group of radiopharmaceutical companies dedicated to the development and proprietary production of novel radiopharmaceuticals and radiomedical devices. Today, more than 50 highly trained employees bring in their profound knowledge and experience of meanwhile more than a decade, focusing on next generation radioisotope sourcing and processing for the treatment of numerous serious oncological diseases. The company's main goal is to improve the wellbeing and quality of life of patients by bringing a new generation of targeted radiopharmaceuticals for theranostics to the market.

CONTACT:

Konstantin Zhernosekov

Head of Product Management & Marketing

phone: +49 89 3298986-32

e-mail: Konstantin.Zhernosekov@itg-garching.de

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Steffen Schuster

Chief Executive Officer (CEO)

phone: +49 89 3298986-22

e-mail: Steffen.Schuster@itm.ag

ITM Isotopen Technologien München AG

Aufsichtsratsvorsitzender - Udo J. Vetter, Vorstandsvorsitzender - Steffen Schuster, Sitz der Gesellschaft - Lichtenbergstr. 1, 85748 Garching - HG München - HRB 154944