This year, this award has been given to Dr Nicolaas Duneas and Dr Nuno Pires of Altis Biologics in conjunction with the Tshwane University of Technology (TUT) in Pretoria for the development of innovative products for the treatment of bone injuries and voids.
Altis Biologics is a regenerative medicine company focused on developing and bringing new biomaterials and regenerative biological products to the international market, with a particular emphasis on orthopaedic and dental tissue regeneration.
In 2004 Altis invited TUT and Bone SA, an organisation incorporated not for gain, to form a consortium that was later awarded an Innovation Fund grant totalling R14,8-million to advance Altis’s intellectual property related to porcine bone morphogenetic protein complex as a human bone regeneration biomaterial through clinical trials.
Bone grafting is used to treat patients needing bone replacement and regeneration as a result of a non-healing fracture, voids — where a piece of bone is missing — and bone degradation due to diseases such as osteoporosis.
The standard way to regenerate bone in the case of serious trauma injuries is to take bone from the patient’s own hip (referred to as an autograft) or from deceased donors to use in a graft (an allograft).
“An autograft is a very invasive procedure, requiring additional expensive and painful surgery, which may later lead to other complications such as gait disturbance, to remove the donor material from a patient already requiring surgery to repair a bone injury,” says Duneas.
“An implant is also preferred by many surgeons versus tissue-banked bone from deceased donors as it overcomes the risks associated with the possible transmission of viruses and overcomes many of the inconsistent healing characteristics of individual allografts,” says Pires.
The need to find a viable alternative to the traditional method of harvesting bone material spurred Duneas and Pires to create a graft substitute known as osteogenic bone matrix, or OBM. Essentially an implant, this performs the same function as bone grafts in that it causes new bone to form when implanted into the patient.
With products spanning the pre-clinical, clinical development and commercial green-light stages, Altis’s main focus is on the commercialisation of naturally derived bone morphogenetic protein (BMP) based products, and collagenous matrices intended for the treatment of bone injuries and bone voids. These matrices are the “foundations” on which bone regeneration is built.
OBM has undergone preclinical (animal) studies as well as early phase human clinical studies and has recently received permission from the health department to be marketed as a medical device in South Africa The technology underlying Altis OBM are the BMPs.
“This is a family of growth factors capable of rapidly inducing new bone formation,” says Pires.
Altis’s focus is on developing and taking to market regenerative products derived from pigs, says Duneas. “The company has also developed an injectable delivery system based entirely on bone matrix and specialises in the purification of type I collagen from porcine bone matrix, which is used as the delivery system for porcine BMP complex.”
Duneas says the choice of porcine material for the development of OBM was made because of its convenience and availability.
“We had already proved the power of our BMP technology having successfully completed human clinical trials using human donor bone, and licensed the use of our intellectual property to our partners Bone SA and the Centre for Tissue Engineering, a human tissue bank located at the TUT. But to make the technology commercially feasible we knew we had to have a slaughterhouse mammal, so the questions became which of these was most compatible with humans, and would be the safest to use. Because pig material is already used in medicine, with porcine heart valves, for example, being used in human transplants, we took the decision to use this for our research, which has given us Altis OBM.”
“This is a porcine BMP complex and collagen combination, and is undergoing human clinical testing. OBM has to date been proven safe and effective in animal and early stage human studies,” says Duneas.
This area of biotechnology has huge potential, says Pires. However, private sector biotech funding in South Africa is close to non-existent, especially for the “bench to bedside” development of products such as OBM.
“There is some government funding available, but we would like to see private sector funding made available for the development of products like ours, and more opportunity to partner with other research and development scientists as there are limitless possibilities for the use of Altis’ technology platforms that could lead to many new technologies with synergistic potential,” says Pires.