Biomira Completes Enrollment in Phase II Lung Cancer Trial; Follow-On Trial On Schedule For First Quarter 2000 Start Date
Monday December 20, 8:00 am Eastern Time
Company Press Release
SOURCE: Biomira Inc.
EDMONTON, Alberta, Dec. 20 /PRNewswire/ -- Biomira Inc. (Nasdaq: BIOM - news; Toronto: BRA - news) announced today that it has completed enrollment of a Phase II clinical trial of BLP25 vaccine for advanced non-small cell lung cancer (NSCLC). Results of a Phase I trial in the same indication were reported in March 1999.
``We are extremely encouraged by preliminary immunological data that suggest BLP25 can induce potent T-cell responses in patients with non small-cell lung cancer,' commented Michael Longenecker, PhD, Senior Vice President, Research and Development at Biomira. ``As we continue to gather more information about this novel compound, we are increasingly excited about the potential of BLP25 vaccine, not only in NSCLC, but also in treating other common cancers. We expect to begin the second stage of our Phase II studies early next year in NSCLC as planned, while continuing to collect data from our research so far.'
The primary purpose of this initial Phase II clinical trial is to determine whether a higher dose and more frequent administration of the vaccine will enhance its effect in patients with advanced non-small cell lung cancer. The trial involves seven patients and is being conducted at the Cross Cancer Institute in Edmonton, Alberta, and the Company intends to continue accepting patients into the current trial until the second stage of Phase II testing begins.
``We are encouraged by early trends that indicate an apparent therapeutic effect,' said Alex McPherson, MD, PhD, President and CEO of Biomira. ``We are excited about moving this second product candidate forward. Our lead product candidate, THERATOPE© vaccine, is now in Phase III clinical trials.'
The Company plans to start the second stage of the Phase II studies with BLP25 in the first quarter of 2000 to determine whether the addition of the immune enhancer Liposomal Interleukin-2 (L-IL2) will add to the potential therapeutic value of this product candidate. This portion of the clinical trial program will test BLP25 vaccine plus L-IL2 and will involve up to 20 patients.
Results of a Phase I trial of BLP25 revealed that the product was well tolerated and triggered a cytotoxic T-lymphocyte (CTL) immune response against cancer cells.
According to the American Cancer Society 1998 statistics, there are approximately 171,000 new cases in the U.S. of non-small cell lung cancer each year and 160,000 deaths in the U.S. each year, making it the number one cause of death among all cancers. Biomira estimates the market potential is 100,000 patients annually in the U.S. alone.
BLP25 is a therapeutic vaccine designed to induce an immune response to cancer cells. BLP25 vaccine incorporates a synthetic 25-amino acid sequence of the MUC-1 cancer mucin, encapsulated in a synthetic liposomal delivery system (a fat droplet smaller than a red blood cell). The liposome enhances recognition of the cancer antigen by the immune system and facilitates better delivery. |
