As The First Biopharmaceutical Company Worldwide, apceth Receives Approval For A Clinical Trial With Genetically …

apceth's first innovative cellular anti-cancer drug based on modified mesenchymal stem cells enters Phase I / II of clinical testing multicenter trial will start in Munich in Q2 2013 already broad international interest from industry and academia

Munich Germany /B3C newswire/ - As the first biopharmaceutical company worldwide, apceth GmbH & Co. KG with its headquarters and manufacturing sites in Munich and Ottobrunn (near Munich) has received approval to conduct a clinical cancer trial with its genetically modified, adult mesenchymal stem cells. This is an entirely new approach for the treatment of advanced types of cancer for which there is currently no effective treatment available.

The multicenter, open-label trial will recruit patients suffering from advanced adenocarcinomas of the gastrointestinal tract. This innovative therapy is based on mesenchymal stem cells harvested from the patient's own (autologous) bone marrow, which are processed, genetically modified and re-infused into the patient. The stem cells thus modified specifically target the tumor and the cytotoxic gene product is selectively activated at the site of the tumor or its metastases to increase local efficacy and to reduce systemic toxicity, one of the main problems of systemic chemotherapy. This unique principle is also applicable to other cancer types.

This clinical trial will be initiated at the University Hospital Grosshadern in Munich in the next few weeks in collaboration with experts from the National Center of Tumor Diseases (NCT) in Heidelberg and the Karolinska Institute in Stockholm.

There is already broad international interest in expanding this trial and further developing this innovative therapy option. John Marshall, Professor of Oncology and Director at the Lombardi Cancer Center of the Georgetown University in Washington, DC: "This is a very exciting new class of drugs based on adult stem cells delivering a true innovation for patients with advanced cancer. There is a clear unmet medical need for this and we are hopeful that we can begin testing in the US soon."

Also other leading cancer centers in the USA have already expressed their interest, such as the M.D. Anderson Cancer Center in Houston and the Fred Hutchinson Cancer Research Center in Seattle.

This to date unique and innovative approach in the treatment of cancer is part of apceth's corporate strategy of developing sustainable cell-based therapeutics. Other clinical trials are already testing the treatment of advanced vascular diseases, while other cellular drugs are under development.

Besides its own internal research and development programs, apceth also collaborates with international pharmaceutical and biotech companies, who are showing increasing interest in cell- and gene therapeutics as a next-generation treatment option and entering the emerging field of "regenerative medicine".

While apceth is already being supported by numerous national and international grants, the company has just concluded another round of financing of 22M from their existing investors. This will enable apceth to further develop its innovative cellular therapeutics right up to the clinical testing stage.

About apceth apceth is one of the leading European pioneers in the development, GMP manufacturing and clinical implementation of innovative (stem) cell-based therapies for the treatment of malignant and non-malignant diseases. apceth combines the principles of stem cell biology with groundbreaking technologies, applying the highest standards for GMP manufacturing, safety regulations and quality control according to the European Regulation for Advanced Therapy Medicinal Products (ATMPs). apceth provides novel cell therapy solutions for the treatment of clinical conditions for which no satisfactory treatment options are available to date. Its proven know-how in all aspects of ATMP pharmaceutical development and production (GMP manufacturing license in accordance with 13 and 20b AMG) also enable apceth to offer GMP/GCP-compliant contract manufacturing services for various ATMPs.

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As The First Biopharmaceutical Company Worldwide, apceth Receives Approval For A Clinical Trial With Genetically ...