By Mary Welch
Celtrix Pharmaceuticals Inc. reported positive preliminary results from a Phase II trial with SomatoKine, which is insulin-like growth factor-1 coupled with its natural binding protein.
The drug was tested for its effect on the immune systems of severely burned children.
"What happens is that after a severe burn, the body goes into a catabolic state, which is going toward a deteriorating instinct rather than a healing one," says Andreas Sommer, president and CEO of Santa Clara, Calif.-based Celtrix. " If we can substantially improve the catabolic state and change it into an anabolic one — or healing and a building mode — then the patient heals faster and there is less cost."
Study of SomatoKine continues in a Phase II clinical feasibility test and final findings should be ready by the end of the year. Barring any unforeseen problems, Phase III trials will start in 1999.
The Phase II trials are being conducted on 36 children at the Shriners Hospital for Children and the University of Texas' medical branch, both in Galveston, Texas. Early results show SomatoKine helped balance patients' immune systems, and the effect continues even after the treatment period.
According to the data, lymphocytes isolated from treated patients showed a 280 percent increase in the production of interleukin-2, and a 25 to 90 percent increase in the creation of interferon gamma, both key immune system modulators. Usually in burn patients the levels of interferon gamma and interleukin-2 drop substantially, while interleukin-4 and interleukin-10 rise.
The immune system imbalance further upsets the body's ability to produce normal immune responses. As a result, a patient has more susceptibility to serious infections, which can interfere with skin graft procedures and, in extreme cases, trigger multi-system organ failure and possibly death.
Research also is verifying that SomatoKine improves the healing time needed by healthy skin to recuperate in order to be used again in skin grafts. When a burn patient needs skin grafts to replace dead skin, an average of four to five procedures is required before the damaged skin is able to grow normally. The area from which healthy skin is taken also needs time to recover so it can be harvested again, and grafted onto the damaged skin. Recovery usually takes between five and nine days.
"If we can shorten that harvesting time by 20 to 25 percent, that means the patient recovers quicker and has a shorter hospital stay," Sommer said. "There's an economic argument as well as a healing one."
Tests on six severely burned children, ages two to 18, are encouraging, he added.
"Our initial studies show that it makes healthy skin grow back faster," Sommer said. "That will be one of the areas we want to study more thoroughly this year."
Celtrix also is evaluating SomatoKine is a Phase II study of its use in regenerating lost muscle, bone and other tissues.
The company's stock (NASDAQ:CTRX) closed Monday at $3.25, up $0.50. *