Apthera Announces Optimal Dose and Schedule of NeuVax for Phase III Clinical Trial in Breast Cancer
SCOTTSDALE, Ariz., Oct. 1, 2008--(BUSINESS WIRE)--Apthera, Inc. announced the optimized dose and schedule for its lead drug, NeuVax, in treating early-stage breast cancer patients to be used in Phase III clinical trials. Dr. George Peoples, Deputy Director, United States Military Cancer Center, co-authored a publication that appears on the cover of the October 1, 2008, issue of Cancer (Vol.113 Issue 7:1666-75) and details the Phase I/II clinical study results.
The proof-of-concept safety and efficacy trial utilized dose escalation with seven different dose groups evaluated in 99 breast cancer patients to determine the optimal biologic dose for NeuVax based on toxicity and immunologic response. The optimal dose and schedule of NeuVax was established as one milligram of E75 peptide combined with 250 micrograms of GM-CSF (Leukine®) given intradermally monthly for six months. Analysis of the treatment arm revealed that patients receiving the optimal dose regimen had significantly worse prognostic factors prior to treatment compared to patients given lower doses in the Phase I part of the trial, including larger tumors (percentage T2 or larger: 55% vs. 23%; p=.004) and more positive lymph nodes (percentage positive: 76% vs. 37%; p=.001). At a median follow-up of 30 months, the tumor recurrence rate for patients receiving the optimal dose of NeuVax was much lower than that of patients receiving suboptimal doses (3.4% vs. 12.9%). By reference, the control group in the trial receiving standard of care experienced a recurrence rate of 14.8% at 30 months. Immunologic monitoring post completion of the treatment series, that quantified E75-specific DTH reactivity, was predictive of the enhanced therapeutic response by the higher dose of E75.
“These results have allowed us to articulate the optimal dose and schedule for the upcoming Phase III clinical trial. Together with the recently published data on preferential activity of NeuVax in patients with low HER2/neu expression, Apthera has identified a patient population with an unmet medical need for NeuVax in the adjuvant therapy setting,” said Dr. William Gannon, Apthera’s Chief Medical Officer.
Apthera, Inc. is a privately held, Arizona-based biotechnology company developing a pipeline of peptide-based immunotherapies for cancers that express HER2, a well-validated and established oncology target. The Company’s lead product, NeuVax, has shown clinical activity in early-stage breast and prostate cancer. For more information about the Company visit www.apthera.com.
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.
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Posted: October 2008