SentoClone has obtained permission from the Swedish Medical Products Agency and the Ethics Committee to conduct a multi-centre, randomised, controlled Phase II study on 140 patients with advanced malignant melanoma.

There is currently no product on the market for advanced cell therapy treatment of cancer. The patented immunological method developed by SentoClone AB, could be the first approved treatment of its kind. Sweden's leading research centres on malignant melanoma will participate.

The approved clinical study is randomised, which means that patients will be selected at random to receive either SentoClone® or a standard treatment. Patients' progress will be followed in a structured manner throughout their lives.

"This is an important step for SentoClone AB. The result of the study is intended to form the basis for a Phase III study on malignant melanoma, and both studies will be included in an application to the European Medicines Agency (EMEA) for a marketing authorisation for the treatment method. With good results, SentoClone AB will recruit new staff to develop the product for new cancer forms. In the longer term, this will allow us to grow internationally and reach the global market", says Johan Järte, CEO of SentoClone AB.

"The randomised, multi-centre study on malignant melanoma that SentoClone AB will conduct is at the forefront of clinical research. Initially, mainly research centres in Sweden will take part, but we also hope to include patients outside Sweden," says Freddi Lewin, Medical Director of SentoClone AB.

Malignant melanoma, a cancer form that is increasing rapidly
Malignant melanoma is a tumour type that is fast-increasing in incidence and for which late discovery means a very poor prognosis, with a lack of effective treatment methods. In Sweden, approximately 2,200 new cases are diagnosed each year and about 10-15 percent of these are considered advanced at the time of diagnosis. Every year, approximately 15,000 people in the industrialised world are diagnosed with advanced malignant melanoma.

A patented treatment method
In short, treatment with SentoClone® means that the body's own immune system is activated and reinforced. The patient's white blood cells are multiplied and then reintroduced to the patient via a transfusion. Pilot results from around 100 patients with varying cancer diagnoses have been promising and without serious side effects.

Strict manufacturing requirements
As of 30 December 2008, a new European Regulation, (EC) No. 1394/2007, applies for medicinal products for advanced therapies. This means that the method SentoClone AB is developing for the immunological treatment of cancer is classed as a medicinal product. The company has invested SEK 20 million in a new laboratory to be able to meet current requirements for the manufacture of biological medicinal products. Following the Good Manufacturing Practice (GMP) inspection by the Swedish Medical Products Agency, encompassing premises, quality control systems and documentation, SentoClone AB obtained permission to manufacture medicinal products for clinical trials in May.

Financing
In May SentoClone AB received a grant from VINNOVA of SEK 4 million, which will contribute to faster execution of the planned clinical study. In addition to support from VINNOVA, SentoClone AB has to date been financed with venture capital.

For more information, please contact:

Johan Järte
VD
SentoClone AB
Mobil +46 70 652 45 32
johan.jarte@sentoclone.com

Vera Franzén
Registreringschef
SentoClone AB
Mobil +46 73 520 66 94
vera.franzen@sentoclone.com

Birgitta Plyhm
PR/Press
Mobil +46 70 777 12 90
birgitta@plyhm.se

SentoClone AB is a Swedish life science research company that develops a patented method whereby the body's immune defence system is activated and strengthened to fight cancer. The company was established in 2004, has 28 employees and is located in Sundbyberg, outside Stockholm. For further information, please visit www.sentoclone.com.