A new agent, undergoing advanced clinical research trials at the University of Utah Medical Center, could be approved for use by the federal Food and Drug Administration as early as 1990 for the treatment of brain cancer.
This is promising news to the more than 17,000 Americans who annually are diagnosed with primary brain cancer. Another 90,000 Americans a year show first-time evidence of metastatic brain cancer.Yet historically, patients with brain cancer have very poor survival rates - about 5 percent over five years.
Researchers are hopeful that ImuVert, an anti-cancer agent produced by Cell Technology in Boulder, Colo., can improve these statistics.
Company officials say the outlook is promising.
W. Terrance Schreier, Cell Technology president, told the Deseret News that initial trials have shown that ImuVert is the only non-chemotherapeutic agent that has shown a high level of efficacy with relatively few side effects for the treatment of cancer - particularly brain cancer.
ImuVert, he explained is not a drug. Rather it's a biological response modifier, a substance used to initiate and enhance a natural, sequential, multifaceted immune response to cancer.
Between 1985-86, the company completed three Phase I toxicity trials, in which ImuVert was given to a total of 88 cancer patients at various dosage levels. "These patients had been diagnosed with advanced cancer and virtually all had failed to respond to multiple conventional cancer treatments such as surgery, radiation and chemotherapy," Schreier said.
The agent, administered by injection, was well-tolerated at all dosages and schedules tested.
Schreier said that although temperature elevation and other flu-like symptoms commonly occurred after ImuVert treatment, there were no serious organ system toxicities experienced by patients participating in the trials.
In addition, the condition of 35 percent of the 88 patients evaluated improved.
Based on the safety results from these trials, the company focused its Phase II trial on brain cancer "primarily due to efficacy results observed with brain cancer patients during Phase I trials and the lack of any meaningful treatment commercially available for this lethal disease," Schreier said.
The advanced brain tumor trails are currently under way at the U. Medical Center, under the direction of Dr. Kurt Jaeckle, assistant professor of neurology.
"In the Phase II Utah brain cancer trial, ImuVert has shown a stunning 40 percent response rate in 17 patients with terminal brain tumors," Schreier said.
Patient responses included one complete response (no detectable tumor) in one patient after 36 weeks of treatment without recurrence at 48 weeks; one 93 percent reduction of tumor size after 24 weeks of treatment which has remained stable at 36 weeks.
Schreier said there were also two minor responses and two stable patients with no increase in tumor size. "Average survival for patients has been five months and three out of the 17 have survived to 11 months," he said.
Last month advanced Phase II/Phase III brain cancer trails also began at the U. ImuVert will be compared against various chemotherapeutic agents presently used in treating brain cancer.
If the results of these trials prove successful, the company may seek FDA approval in late 1989 to begin marketing ImuVert for the treatment of brain cancer as early as 1990.
The chief executive officer emphasizes the word "treatment."
"The company's tag line, `improving the quality of life,' simply sets up the notion that we are not in the business to cure cancer," he said. "There is no such thing as curing cancer."
ImuVert, he said, is just an alternative to the conventional cancer therapies - surgically removing the cancer, burning it out through radiation, or poisoning it with chemotherapeutic agents.