Low HER2 Expressing Breast Cancer Patients Respond Preferentially To Apthera's NeuVax

Main Category: Breast Cancer
Also Included In: Cancer / Oncology
Article Date: 16 Apr 2008 - 4:00 PDT

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Results were announced from analysis of a randomized safety and efficacy clinical trial studying NeuVax (E75) in the adjuvant treatment of early-stage (node-positive and high risk node-negative), HER2-positive breast cancer. Data presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego showed that patients with low-expressing HER2 tumors experienced decreased breast cancer recurrence and no mortality to-date following treatment (Abstract #2545, Monday, April 14, 2008, 3:40 p.m. PDT).

Dr. Alton Charles Morgan, President and CEO of Apthera stated, "These results are encouraging for HER2 low-expressing breast cancer patients who have few treatment options in the adjuvant setting and are not typically eligible for Herceptin® therapy."

The Cancer Vaccine Development Program (CVDP) at Brooke Army Medical Center in San Antonio, Texas conducted a subset analysis review of 163 patients with breast cancer enrolled in the NeuVax trial to determine whether the level of HER2 expression affected response. Of the patients assessed, 92 underwent treatment. Within the treatment group, 56 (66 percent) were defined as HER2 low-expressors. The control group included 44 (67 percent) low-expressors.

Low HER2 expressing patients maintained circulating, E75 peptide reactive T-cells after 1 year whereas patients with HER2 over-expressing tumors returned to pre-immunization levels. At a median follow-up of 30 months, disease recurrence was substantially reduced for treated patients with low HER2 expression. Low-expressors by IHC in the treatment arm of the study experienced 8 percent recurrence, compared with 21 percent for patients in the control arm. Furthermore, the mortality rate among low-expressors by IHC with recurrent disease was 0 percent among treated patients, versus 20 percent among controls (p=0.04).

Taken together these findings may be significant for the greater than 50 percent of breast cancer patients whose tumors fall into the HER2 low-expressing category and who are not typically eligible for Herceptin treatment.

About Apthera

Apthera, Inc. is developing a pipeline of peptide-based immunotherapies for cancers that express HER2/neu, a well-validated and established oncology target. Apthera is privately held with headquarters in Scottsdale, Arizona.

http://www.apthera.com

About NeuVax

NeuVax is a HER2/neu peptide-based T-cell immunotherapy aimed at preventing disease recurrence and prolonging survival in cancer patients that have tumors expressing the HER2/neu oncoprotein. To date, clinical study results have demonstrated that NeuVax significantly reduces the rate of cancer recurrence while showing minimal side effects.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are not historical facts and are subject to risks and uncertainties which could cause actual results and the timing of certain events to differ materially from those set forth in or implied herein including, without limitation, risks associated with clinical development, regulatory approvals, product commercialization, intellectual property claims litigation and other risks associated with the Company's proposed activities.

Apthera