Liposomal Vaccine Shows Specific Immunotherapy In Stage III Disease.(non-small cell lung cancer)

2001 OCT 17 - (NewsRx.com & NewsRx.net) -- Biomira, Inc. reports that its liposomal candidate vaccine has shown specific immunotherapy in a Phase I study of non-small cell lung cancer.

The trial involved 16 evaluable patients with non-small cell lung cancer (NSCLC). The patients were randomized into two groups, one receiving a 20 mg dose and the other, a 200 mg dose of the vaccine. Both doses were well tolerated. Immunological assays revealed the generation of cytotoxic T-lymphocytes (CTLs) against MUC1 positive tumor cell lines in five of 12 patients. These patients did not have MUC1 specific CTLs prior to receiving the vaccine. This study formed the basis for moving forward with additional clinical studies with BLP25 vaccine.

The results from its Phase I study of BLP25 vaccine were published in the August 1, 2001 edition of the peer-reviewed journal Clinical Lung Cancer. Entitled "Phase I Study of the BLP25 (MUCI Peptide) Liposomal Vaccine for Active Specific Immunotherapy in Stage IIIb-IV NSCLC," the authors concluded that, "the vaccine was well tolerated and showed important signs of immunogenicity." The lead author of the paper was Dr. Martin Palmer of the Alberta Cancer Board, Cross Cancer Institute in Edmonton, Alberta and lead investigator of the BLP25 vaccine trials.

Following the Phase I trial, Biomira initiated a Phase II trial of BLP25 vaccine in August 1999 enrolling eight patients with Stage IIIB and Stage IV NSCLC. The Company increased the dose of BLP25 vaccine to 1,000 mg and increased the injection schedule to weekly injections over an eight-week period. The results showed that six of the eight patients enrolled mounted a notable T-cell proliferative response that was specific for MUC1.

In January 2000, based on preclinical data developed at Biomira, the Company initiated the second stage of its Phase II clinical trial program with BLP25 vaccine for advanced NSCLC. The overall purpose of this program was to determine if the addition of Liposomal IL-2 (L-IL-2) would further enhance the immune response to the vaccine in patients with NSCLC, while preserving a satisfactory safety profile. In this study of 18 patients, Biomira's proprietary immune enhancer L-IL-2 was added to the treatment program. Safety and immunogenicity were the study endpoints.

The first 10 patients enrolled received 500,000 international units (IU) of L-IL-2 per weekly injection and the next eight patients received 2 million IU of L-IL-2. Both doses of L-IL-2 used in combination with BLP25 vaccine showed ...