Celtrix Pharmaceuticals Inc. said its SomatoKine therapy significantly improved cardiac function in burn trauma patients in a Phase II study.
"The issue concerning the heart in severely burned persons is similar to that of congestive heart failure," said Andreas Sommer, president and CEO of Santa Clara, Calif.-based Celtrix. "The data strongly show SomatoKine increases heart output and does it safely."
The drug is a recombinant complex of insulin-like growth factor-1 (IGF-1) and its binding protein, BP3. Studies have shown the drug has potential as a hormone replacement therapy, stimulating the production of bone and muscle mass. In effect, it is an anabolic agent that prevents tissue breakdown.
Six severely burned children receiving an intravenous infusion of SomatoKine for five days showed a 16 percent improvement in cardiac output and a 15 percent increase in stroke volume, as compared to saline-treated controls. Other patients given different dose levels showed a lesser response. No side effects were noted. In addition, the observed that improvements were not accompanied by undesirable increases in left ventricular wall thickness, or increased oxygen consumption by the heart muscle.
Following severe burn injury, functional changes occur, including a decrease in heart output. This deficiency can lead to inadequate blood supply going to other parts of the body, which can trigger tissue damage, organ failure, shock and ultimately death.
Some anabolic agents, such as IGF-1, have been known to attenuate cardiac dysfunction after severe burn trauma, but these agents have systemic side effects, such as hypoglycemia.
The study was conducted on 36 children at the Shriners Hospital for Children and the University of Texas' medical branch, both in Galveston. Early results showed SomatoKine helped balance patients' immune systems, an effect that continued even after the treatment period. Data also showed that SomatoKine improves the healing time needed by healthy skin to recuperate in order to be used again in skin grafts. (See BioWorld Today, May 5, 1998 p. 1.)
Celtrix will gather more data from the trials before seeking a corporate partner to help underwrite Phase III trials for the severe burn trauma indication, Sommer said.
SomatoKine also is in Phase II trials for the treatment of severe osteoporosis and diabetes. In the osteoporosis indication, the trial is finishing up and a presentation will be made next month at the American Society for Bone and Mineral Research conference, in San Francisco. The diabetes trial is about three-quarters finished, and the company expects to report results in early 1999, Sommer said. As with the burn trauma indication, Celtrix wants a corporate partner before entering Phase III studies.
Restructuring Slashes Burn Rate By 85 Percent
The company is better positioned to develop SomatoKine, following its September decision to end its manufacturing operation and cut 90 percent of its staff. Celtrix had enough SomatoKine in stock for the next two years. (See BioWorld Today, Sept. 21, 1998 p. 1.)
"We cut our burn rate from $13 million to $2 million, and today we closed on a $2 million private placement that was committed by investors in September," Sommer said. The private placement consisted of 4 million shares of common stock. In results for fiscal year 1999's second quarter, ended Sept. 30, Celtrix reported revenues of $23,000 and a net loss of $8.6 million, or $0.41 per share. In the second quarter of fiscal 1998, revenues were $55,000, and the net loss was $3.2 million, or $0.15 per share.
The company has enough funds to operate through the third calendar quarter of next year. The most recent Phase II data were disclosed at the American Heart Association conference in Dallas.
Celtrix's stock (NASDAQ:CTRX) closed Thursday at $1.25, up $0.187. n