 |
 |
 |
 |
 |
 |
 |
Pipeline The lead compound C-Cure 709 – a potential breakthrough in cancer treatment
C-Cure 709 is a clonal, continuous T-lymphocyte. The product is a potential breakthrough in the treatment of metastatic malignant melanoma (birthmark cancer).
TCR-directed tumor cell killing
Click on the image to enlarge
Malignant melanoma arises in the pigmented melanocytes that are most frequently found in human skin, but also in many other organs, e.g. the eye and mucous membranes. The first symptom of malignant melanoma is usually the appearance of a new pigmented naevus (commonly known as “birthmarks”) or the growth or change of colour of an existing naevus.
Around 80% of the patients have clinically localised disease at the time of diagnosis. The standard treatment for skin melanoma is surgical removal.
After surgery, the most common sites of initial relapse are the skin, subcutaneous tissue, and lymph nodes. Distant metastases are most often seen in the lungs followed by the brain, liver, gastrointestinal tract and bone. Recurrences are surgically removed when technically feasible.
When surgical removal is impossible the prognosis is grim. Currently the most widely used single agent chemotherapy (decarbazine) in the treatment of metastatic malignant melanoma shows overall response rates of 10-20%, but survival time is not improved. Combination chemotherapy has been tested in large phase III trials, but without any obvious advantage over dacarbazine alone.
C-709’s dual mechanism of action C-Cure 709 is a human T-lymphocyte genetically engineered to recognise and kill melanoma cells. C-Cure 709 cells are injected into the tumour and kills large numbers of malignant melanoma cells. This activates the patient’s own immune system to participate in the tumour eradication process. Once activated by C-Cure 709, the patient’s own immune system may find and destroy tumour cells at other sites than those injected with C-Cure 709 (i.e. unrecognised micro-metastases, or sites that are non-accessible for injection).
The market Approximately 20% of patients with malignant melanoma develop metastatic disease. Based on data from the International Agency for Research on Cancer (www.iarc.fr) the incidence of metastatic malignant melanoma in EU, USA, Canada, Australia, New Zealand and South Africa is over 20,000 cases per year. Half of those patients have the tissue type required for treatment with C-Cure 709. Hence C-Cure 709 targets a patient population in excess of 10,000 per year. The incidence is on the rise in all the regions / countries mentioned, mainly as a result of recreative sunlight exposure and the ageing western populations.
Development and registration status C-Cure 709 has completed a phase I study. The product has was granted Orphan Drug status by the European Medicine Agency (EMEA) in May 2004. A phase II study is currently under preparation for subsequent execution in the second half of 2006.
Intellectual property The unique and proprietary technology of CellCure allows the company to produce unlimited amounts of gene-transduced T-cells outside the human body. CellCure has filed two families of patent applications and its lead compound (C-Cure 709) is expected to be covered by patent protection until 2021 in major western countries. The above mentioned European orphan drug destination furthermore guarantees C-Cure 709 a market exclusivity of ten years from first year of launch in EU.
Other potential applications of CellCure’s cell growth technology C-Cure 709 is only one of several possible applications of the cell growth technology developed by CellCure. The company possesses several continuous T-cell lines which may be engineered to recognise other tumour types than malignant melanoma. As a result, the company is endowed with an exciting “hidden upside” that has yet to be fully unveiled through its future R&D work. |
