The South African Cancer Association (Cansa) estimates that at least 100 000 people are diagnosed with cancer in the country each year. This equates to a lifetime risk of one in six persons being diagnosed.

Cansa head of health Professor Michael Herbst says the 2004 data from the National Cancer Registry shows that 55 772 people were diagnosed officially with cancer each year, but that many diagnoses from the private health sector are not included in this figure.

Statistics from the Medical Research Council, which were last updated in 2010, show that lung cancer is responsible for the most deaths in both males and females, with breast cancer second. Other cancers that have been responsible for significant numbers of deaths in the country include oesophageal, cervical, liver, colorectal, prostate, stomach and pancreatic cancers, and leukemia.

However, compared with other countries, South Africa’s cancer diagnosis rate is still fairly low, with the highest cancer rate for men and women found in Denmark. In 2008, about 326 people in 100 000 were diagnosed in that country, compared with South Africa’s 202 in 100 000 for the same year.

Fighting Back
Globally, the search for cures has been frustratingly slow. In addition, because cancer is a class of diseases, some believe it is unlikely that there will ever be a single remedy. The search for a so-called ‘silver bullet’ is, thus, increasingly being displaced by more complex treatment regimes.

Nevertheless, South African biopharma-ceuticals manufacturing company Genius Biotherapeutics is hoping to play a role in dealing with the cancer scourge by researching and developing new treatment methods.

Speaking to Engineering News, Genius Biotherapeutics CEO Ismet Amod explains that currently the treatment of cancers requires cytostatic chemotherapy, whereby chemical-based drugs target rapidly dividing cells, including tumour cells and rapidly dividing cells, such as hair follicles and cells in bone marrow and the digestive tract. “As a result, patients undergoing chemotherapy suffer significant side effects and a poor quality of life,” he notes.

The company, which is 49.5%-owned by black-owned and black-controlled investment holding company Sekunjalo, has, through research, proven that the use of dendritic cell vaccines may offer a viable alternative through the use of the patient’s own immune cells, which would have been primed to target specific cancers.

“Through the use of the patient’s own dendritic cells, the rejection of cells is eliminated and the cells are programmed and activated to target the tumour in a more effective and safer manner than current techniques. This also translates into fewer side effects as opposed to radiation or chemotherapy,” Amod says.

The treatment therapy is already being used by a number of companies. “For example, the treatment is already used by Nasdaq-listed biotechnology company Dendreon for the treatment of prostate cancer,” he points out.

Dendreon has managed to successfully register its technology for the treatment of prostate cancer with the US Food and Drug Administration. “Being a novel and cutting-edge therapy that is ‘designed’ for each patient’s need, there are many trials in progress globally on a number of cancers,” Amod adds.

How It Works
Amod explains that, with each patient, dendritic cells are harvested from the patient’s own blood or bone marrow. The immature dendritic cells are then exposed in vitro to an antigen or a foreign protein, whereafter it will grow, producing mature antigen-presenting dendritic cells in vitro.

The antigen may be a cancer antigen, for example a tumour-associated antigen, and may alternatively be an antigen from a human parasite, virus or microorganism. “Once matured, a vast number of them are injected back into the body with the cancer. The dendritic cells, once reintroduced into the body, then act as an ‘alarm’, alerting the body’s immune responses.

“These are specialised cells, called T-cells, or ‘killer’ cells, that become cytotoxic, or cell destroyers. An army of T-cells is then released from the lymph nodes, looking for, and binding to, the surface of any cell that has the same protein combination, resulting in the cancer taking a serious hit,” Amod adds.

Going Global
In April this year, the company was the first in years to gain permission from Finance Minister Pravin Gordhan and the South African Reserve Bank to list on an overseas stock exchange. A primary offshore listing for a local company has not been permitted since 2000 and the company is in discussions about listing on a foreign stock exchange, possibly in North America and Europe.

Sekunjalo chairperson Dr Iqbal Survé argues that it is difficult to find financing for the research on the South African investment market, as it is considered almost too futuristic. The overseas listings will assist Genius Biotherapeutics in securing the capital to develop the technology even further.

Genius Biotherapeutics will now, with the capital investments from the listings, be able to run expensive overseas clinical trials, which it needs to commercialise its 23 patents in South Africa. It is estimated that the US clinical trials will cost about $30-million.

Each patent covers different novel technologies for dendritic cells and retroinverse peptides in many different countries of the world. While Amod cannot confirm as yet where all the trials for the patents will take place, he points out that the majority would most probably take place in South Africa.

When the trials have proven successful and funding has been secured, the company plans to roll out all the patents in South Africa first. “We want to make the technology and treatment available to everybody,” Amod notes.

The initial stages of the research and development were done in collaboration with the University of Cardiff, in Wales, and locally with the University of Pretoria. “We will be continuing with the collabor-ations and, in fact, seeking more partnerships, such as with the University of Cape Town, where the company already hosts an immunology unit.

“The unit performs complex bioassays, used as release criteria for our final filled and formulated product, Repotin,” Amod says.

Other Technologies
Genius Biotherapeutics is also involved with the production of other cost-effective and modern biotechnology products for human pharmaceutical use, such as Repotin.

Repotin ampoules contain the active ingredient recombinant human erythropoietin (r-HuEPO), which is manufactured in the cGMP, or current good manufacturing practice, cell culture facility in Centurion, near Pretoria.

Human erythropoietin is a potent hormone produced mainly in the kidney. The hormone regulates the production of erythrocytes in the bone marrow and thus the circulating erythrocyte mass and oxygen-carrying capacity of the blood. The production of erythropoietin by the kidney is, in turn, regulated by tissue oxygenation in the kidney and erythropoietin is the hormone responsible for adjusting the red cell mass in altitude changes.

Recombinant human erythropoietin has had a major impact on the treatment of the anaemia of chronic renal failure and is used widely to treat erythropoietin-responsive anaemias.

Erythropoietin is the largest modern biotechnology product in the world by sales volume.

Genius Biotherapeutics subsidiary, Ribotech, which is a state-of-the-art pilot production facility, is also, currently, developing granulocyte colony-stimulating factor used in the treatment of neutropaenia, a granulocyte disorder in cancer patients undergoing chemotherapy. The facility is located in Goodwood, Cape Town.

There is little question, though, that a breakthrough in the cancer area could be a game changer for the company and for the South African biotechnology sector as a whole.