Novel cancer compound targets EGFR pathway; demonstrates positive trial results.

2004 JUL 14 - (NewsRx.com & NewsRx.net) -- CancerVax Corp. (CNVX) announced data from phase I/II clinical trials of an investigational specific active immunotherapeutic product candidate (SAI-EGF) that targets the epidermal growth factor receptor (EGFR) signaling pathway were presented during the American Society of Clinical Oncology 2004 annual meeting in New Orleans, Louisiana.

CancerVax has signed nonbinding letters of intent with CIMAB, SA, a Cuban company, and YM Biosciences, Inc., a Canadian company, relating to the license of SAI-EGF and two other specific active immunotherapeutic product candidates targeting the EGFR signaling pathway for the treatment of cancer.

CancerVax has submitted a license application to the United States Department of Treasury's Office of Foreign Assets Control seeking approval to enter into definitive license agreements for this technology, and plans to execute the license agreements for this technology as soon as such approval is received. The company's license application is currently being reviewed, but there can be no assurance such a license will be granted.

Two posters were presented summarizing early-phase clinical data that indicate treatment with SAI-EGF was well-tolerated, resulted in measurable immune responses, and may increase survival in patients with advanced-stage non-small cell lung cancer.

The first poster, entitled "Vaccination with Epidermal Growth Factor (EGF) for Non Small Cell Lung Cancer (NSCLC) Therapy: Preliminary Results from a Randomized Phase II Clinical Trial," T. Crombet, et al., summarized preliminary results of a trial in which 50 advanced-stage NSCLC patients received first-line chemotherapy, and then were randomized to treatment with SAI-EGF or best supportive care.

At this phase of the study, the authors reported survival was significantly greater (p less than 0.05) in patients receiving SAI-EGF compared with randomized controls (mean: 19.54 vs. 13.35 months, respectively; median: 17.33 vs. 10.27 months, respectively). In addition, a significant survival benefit (p less than 0.006) was reported in patients with a good antibody response, defined as at least 1:4000 anti-EGF antibody titers and a 4-fold increase in anti-EGF antibody titers from baseline, compared with patients with a lesser antibody response (mean: 23.93 vs. 13.07 months, respectively; median: not reached vs. 10.53 months, respectively).

A second poster, entitled "Therapeutic Vaccination with Epidermal Growth Factor (EGF) in Advanced Lung Cancer: Analysis of Pooled Data from Three Clinical Trials," G. Gonzalez, et al., summarized data from 3 pilot phase I/II clinical studies evaluating a total of 75 patients with advanced-stage NSCLC who received SAI-EGF.