Can a synthetic product get the job done?
Biotechnology firms aim to find out
While Curative Health Services in East Setauket, NY, decided to produce an autologous compound comprising several growth factors, other biotechnology firms have pursued the development of recombinant growth factors synthesized entirely in the laboratory.Among the latter is the Genzyme company in Framingham, MA. Its topical wound care ointment, currently in clinical trials, contains the single growth factor TGF beta. Genzyme is conducting a 200-patient clinical study to test the effects of the growth factor.
Conducting growth
According to the company, TGF is involved in controlling the wound healing process in both hard and soft tissues. The substance is a protein that is prevalent in platelets, yet is manufactured by all cells in the body, says John McPherson, PhD, senior vice president of research and development at Genzyme.
"It appears to be important in orchestrating a number of cellular functions," McPherson says. "Some people have likened it to the conductor of an orchestra. It influences the production of a variety of other growth factors. One reason we’ve focused on it is that we believe it plays a central role in various aspects of healing."
McPherson adds that the timing and sequencing of growth factor administration also are important in obtaining an optimal response.
Minor improvement won’t be enough
Unless Genzyme’s growth factor has a major impact on wound healing in clinical trials, the company probably will not move ahead to commercialize it, McPherson says.
"In today’s reimbursement environment, me-too products that are just incrementally or slightly better than the standard of care are not going to be embraced, particularly if they are technically complicated to produce and are expensive," he says.
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