Introgen Therapeutics updated its phase 2 trial evaluating Advexin combined with neoadjuvant chemotherapy and surgery in women with locally advanced breast cancer.

After 35 months of follow-up, 92 per cent of the treated patients are alive and 83 per cent have survived without evidence of disease recurrence. Objective clinical responses were seen following the combined therapy in all of the patients with a median of 80 per cent reduction in tumour size. Following tumour shrinkage, complete tumour removal by subsequent surgery was achieved in 100 per cent of the patients. The results of the therapy with the addition of Advexin are better than what would be expected from neoadjuvant chemotherapy treatment alone, claims a company release.

Neoadjuvant treatments are administered prior to surgery and represent a novel and increasingly applied approach to make surgical tumour resections either more complete improving outcomes or less invasive facilitating breast conservation.

Dr. Kerstin Menander, Introgen's vice president of clinical development said, "These data are very encouraging, and suggest that Advexin may be combined with neoadjuvant chemotherapy to improve patient outcomes by reducing tumour size thereby permitting complete surgical tumour removal. The results of this study indicate that ADVEXIN may enhance the clinical benefit of chemotherapies without increasing their toxicity and support clinical applications of Advexin in earlier phases of cancer treatment."

In a novel finding, activation of a local immune response at the site of the tumor was observed. Treated tumours were infiltrated with cells of the immune system that are associated with immune responses against tumours, which may be useful in controlling local disease as well as disease outside the breast.

Dr. Menander continued, "These results are entirely consistent with the known mechanism of action of p53 protein, the tumour suppressor protein delivered by Advexin. P53 normally controls the expression of hundreds of genes many of which have anti-tumour effects. The functions mediated by Advexin p53 therapy include the suppression of tumour growth, the induction of tumour cell death, inhibition of angiogenesis, and stimulation of anti-tumour immunity. Our preclinical and clinical studies have demonstrated these same mechanisms of action for Advexin. The ability of p53 to induce tumour cell death is increased in the presence of DNA damage caused by standard cancer chemotherapy and radiation treatments. A large body of preclinical and clinical data suggests that Advexin interacts synergistically with many standard anti-cancer therapies and we are not surprised that the combination of Advexin with chemotherapy in these patients is generating encouraging results."

There are two multi-national, multi-site phase 3 trials of Advexin therapy, currently underway in recurrent squamous cell cancer of the head and neck. Introgen has received FDA fast track designation for Advexin therapy and Advexin has been designated as an orphan drug for the treatment of head and neck cancer under the Orphan Drug Act.

Introgen Therapeutics Inc. is a biopharmaceutical company focused on the discovery, development and commercialisation of targeted molecular therapies for the treatment of cancer and other diseases.