Glioblastoma Multiforme (GBM)

Gliobastoma multiforme is the most frequent and aggressive brain tumour. The tumour cells have a high resistance to radiation and chemotherapy. They spread and infiltrate the neighbouring tissue so quickly that eradicative surgery is often rendered impossible. Because of the diffuse infiltration into brain tissue, recurrence is often experienced within months of the treatment. Moreover, tumour growth can cause cerebral oedema or an increase in brain pressure, which lead to death in most cases.

Approximately 28 000 new cases of malignant gliomas are diagnosed in the US and EU each year (Source: US National Cancer Registry). The current standard therapy focuses on surgery, radiotherapy and chemotherapy. The relative survival rate for adults diagnosed with GBM is less than 30% within one year of diagnosis. Only 3% of patients live longer than five years after suffering from GBM (Source: Central Brain Tumour Registry of the United States). There is a high unmet medical need for alternative treatments for Gliobastoma patients.

Acute Graft-versus-Host Disease (aGvHD)

Acute Graft-versus-Host-Disease is a common complication following hematopoietic stem cell transplantation or allogeneic bone marrow transplantation. In aGvHD, T lymphocytes of the transplant (“graft”) attack cells of the receiving organism (“host”), which the transplant treats as a “foreign body”. This disease predominantly affects the skin, liver, and gastrointestinal tract of the transplant recipient.

The risk of developing aGvHD after transplantation increases with the age of the patient along with the degree of variance in MHC- Proteins between donor and host, which significantly determines histocompatibility. (MHC: Major Histocompatibility Complex).

Approximately 18 000 patients in the US and EU undergo hematopoietic stem cell or allogeneic bone marrow transplantation each year (Source: European Bone Marrow Transplantation Survey 2006). On average, every second patient develops aGvHD. Despite prophylactic immunosuppressive therapy with corticosteroids, antimetabolites or antibodies, the mortality rate within the first three years after the transplantation is about 70%, depending on the MHC match.

In 2006 Apogenix was awarded Orphan-Drug Status in the EU for APG101 for the treatment of aGvHD.

Solid Tumours

Solid tumours are formed through the uncontrolled growth of somatic cells, leading to neoplasms (abnormal masses of tissue), which may develop into malignant cancer. Over 50% of neoplasms have defects in the apoptotic process, thus making them resistant to therapy, e.g., chemotherapy and radiation.

Cancer types are classified according to the specifically affected organ (e.g., lung cancer, breast cancer) and the tissue origin (e.g., carcinoma, sarcoma). Many cancer types are characterised by their highly invasive growth into surrounding, healthy tissue.

Cancer is the second leading cause of death in industrial nations. According to the World Health Organization (WHO), cancer is a leading cause of death. WHO notes that: “the number of global cancer deaths is projected to increase 45% from 2007 to 2030 (from 7 900 000 to 11 500 000 deaths)”, and that new cases of cancer are estimated to jump from
11 300 000 in 2007 to 15 500 000 in 2030. Existing cancer therapies can prolong survival, but rarely cure the disease.

In the U.S., about 560 000 people die of cancer each year, making it the second leading cause of death (23.1% of all deaths) after heart diseases (26%). It is estimated that there will be some 1 500 000 new cancer cases in 2009. The lifetime probability of an American male developing cancer is 1 in 2 (Source: American Cancer Society). In Germany, there are more than 400 000 new cases of cancer diagnosed every year, 200 000 women and 230 000 men. The median age of onset for this disease is 69 years (Source: Robert Koch Institute).