Biomira, a speculative bio-tech company, is now marketing itself as “The Cancer Therapy People.” Why? The company currently has, among others drugs, a metastatic breast cancer therapy called Theratope which is in Phase III trials. Phase III is the Food and Drug Administrations final step prior to them either approving or denying a product under review. You should know that Theratope has passed Phases I & II with testing showing a high degree of efficacy.
While Theraptope is not a cure for breast cancer the therapy has been found, via Phases I & II tests, to significantly improve long-term management of the disease. And with zero side effects. These earlier Phase tests have shown to allow those with late stages of the disease to improve both their quality of life and length of survival. The Therotope vaccine works by inducing the body to mount an effective immune response against cancerous cells. The Phase III trial, the company says, follows earlier clinical studies(again, Phases I & II) suggesting significant survival benefits for patients with metastatic breast cancer. In one part of two parallel trials(Phase II), patients who received the vaccine had a median survival of 26.6 months compared with 9.2 months for matched patients in a retrospective control group.
The Phase III trial will ultimately involve 900 patients in approximately 75 sites worldwide. They expect to have all 900 patients logged(filled) and beginning the trial by next summer(year 2000). If all goes well then the first interim analysis of data comes out about six months after the trial fills. Based on Phase I & II results the bulls on this thread think this first interium analysis will vouchsafe earlier results, moving BIOM closer to FDA, and international, approvals for one of the first cancer vaccines by any bio-tech company in the industry.
Theratope, and another Biomira drug for lung cancer are part of a portfolio of synthetic therapies the company has under development. Hence their new company slogan, “The Cancer Therapy People”. |
