By Kim Coghill
Corixa Corp. said Wednesday it will file a biologics license application with the FDA in the second quarter 2001 seeking regulatory approval of the Melacine melanoma vaccine.
The application will be based primarily on data collected from the Phase III study of the vaccine for the treatment of Stage II melanoma. The study dates back to 1992 and will include data from 2001. Steven Gillis, chairman and CEO of Seattle-based Corixa, said the most up-to-date data is necessary in order to show the impact on length of life.
The company's stock (NASDAQ:CRXA) gained $3.187 Wednesday to close at $49.437.
Full review of the BLA is expected to take about 12 months, Gillis said. The application will contain safety and clinical efficacy data from all other currently completed clinical studies of Melacine in Stage III and IV melanoma.
Corixa acquired Melacine a year ago through its $56.3 million stock and cash purchase of Hamilton, Mont.-based Ribi ImmunoChem Research Inc. Initially, Corixa was less than excited about the vaccine because the company historically viewed such products as Melacine cautiously. (See BioWorld Today, June 11, 1999, p. 1; and Oct. 8, 1999, p. 1.)
However, Gillis said the company's position has changed based on "new data from the Phase III Stage II trials. We are excited to be moving forward with Melacine."
The vaccine consists of lysed (broken) cells from two human melanoma cell lines combined with Corixa's proprietary Detox adjuvant. Detox adjuvant includes monophosphoryl lipid A (MPL) adjuvant and mycobacterial cell wall skeleton, both of which activate the human immune system in the context of vaccination.
The study examined the effects of Melacine vaccination vs. observation in a randomized, controlled trial of 689 Stage II melanoma patients. Patients in the study were randomized, following surgical excision of their primary tumor, to either observation, as per standard practice, or Melacine therapy, according to three predetermined stratification factors including sex and tumor thickness. Initial results were reported when a predefined number of events (death or disease recurrence) occurred.
According to a statement released by Corixa, analysis of the data in March 2000 revealed a statistically significant improvement in disease-free survival in patients treated with Melacine vaccine (p=0.04).
Malignant melanoma is the most common form of cancer found in women between the ages of 25-29. Malignant melanoma is a lethal form of skin cancer that accounts for only 4 percent of skin cancer cases, but 79 percent of skin cancer deaths.
Corixa continues discussions with Schering-Plough Corp., its worldwide marketing partner for Melacine, regarding regulatory strategies for the vaccine's approval in Europe. Melacine was approved for sale in Canada in November 1999.