By Randall Osborne
With their merger pending shareholders' approval, AVI Biopharma Inc. and ImmunoTherapy Corp. said a Phase II/III trial of Avicine, their therapeutic vaccine for pancreatic cancer, will begin in two to three months.
"This isn't the licensing trial, the one [based upon which] you submit a new drug application," said Denis Burger, president and CEO of Portland, Ore.-based AVI. The Phase III licensing trial, in colorectal cancer, will begin later this year.
"It's not far off," Burger told BioWorld Today.
Formerly known as CTP-7, Avicine is a synthetic peptide conjugate vaccine designed to fight cancer by turning the immune system against cells that carry a hormone common to many tumor types: the human chorionic gonadotropin (hCG) hormone, which boosts growth and shields cells from immune system attack.
Produced naturally during pregnancy, hCG protects the growing fetus from immune system rejection. The hormone also guards against cancerous cells, and is found in highest concentration among the most aggressive cancers.
Gemzar, a chemotherapy drug developed by Indianapolis-based Eli Lilly and Co., will be used with Avicine in the 48-patient trial, which is expected to begin in two to three months. It will finish in about one year.
Designed to conform to U.S. and European regulatory approval requirements, the multi-center study will compare Avicine alone, Gemzar alone, and a combination of Avicine and Gemzar. Primary endpoints will be quality of life and incidence of survival. The trial will be conducted by Philadelphia-based Premier Research Worldwide, a contract research organization.
More than 125 cancer patients have been treated with Avicine, which completed Phase II clinical studies early this year for pancreatic cancer and metastatic colorectal cancer.
"We've completed five clinical trials, three Phase I and two Phase II," Burger said. "We call this one a Phase II/III because we've previously done a Phase II with pancreatic cancer."
The Phase III trial in colorectal cancer is pending manufacture of the vaccine by Peninsula Laboratories, of San Carlos, Calif.
"There are a few more hoops and hurdles to jump, when you're preparing it for a licensing trial," Burger said.
Late last year, AntiVirals Inc., of Portland, Ore., changed its name to AVI when it agreed to pay $24 million in stock to acquire Seattle-based vaccine specialist ImmunoTherapy.
The pair officially entered the deal in February of this year. (See BioWorld Today, Nov. 7, 1997, p. 1.)
"It's been filed with the Securities and Exchange Commission, and we're awaiting comment now," Burger said. "As soon as comment has returned, it will go to the shareholders — let's say in the next two months."
AVI's stock (NASDAQ:AVII) closed Wednesday at $6.75, unchanged. *