Apthera's NeuVax Produces Delays in Recurrence in High-Risk HER2-Positive Prostate Cancer PatientsSCOTTSDALE, Ariz.--(BUSINESS WIRE)--Jun 2, 2008 - NeuVax (E75) produces a delay in disease recurrence in high-risk, disease-free, HER2-positive prostate cancer patients, according to an analysis of the 5-year follow-up data from a Phase I/II clinical trial. Prostate cancer patients demonstrating various levels of HER2/neu expression were treated with NeuVax to determine the ability of the drug to decrease post-prostatectomy prostate-specific antigen (PSA) and clinical recurrences. Data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago showed that the median time to recurrence from prostatectomy was 14 months for the treatment group vs. 8.5 months for the control group. Patients with stable PSA throughout the treatment series exhibited a median time to recurrence of 42.7 months (Abstract #3067, Sunday, June 1, 2008, 2:00 p.m. CDT).
Dr. Joseph Sinkule, Chief Scientific Officer of Apthera, stated, "Though the patient numbers are small, the results are very promising for those prostate cancer patients at high risk for recurrence. This data is sufficient to now plan a larger, randomized Phase II efficacy study in this indication."
About the Clinical Study
40 HER2-positive prostate cancer patients at high risk for recurrence were prospectively identified using the validated Center for Prostate Disease Research (CPDR)/CaPSURE high-risk equation and enrolled in the trial. Patients were allocated to two arms; 21 treated and 19 followed as clinical controls. Patients in the treatment arm received escalating dose-levels of NeuVax and all patients were evaluated for clinico-pathologic factors, PSA recurrence (greater than 0.2 ng/ml), clinical recurrence and survival.
Patients were assigned to treatment or control group based on HLA haplotype. The median follow-up was 58.2 months. PSA recurrence was not different between the treatment (28%) and control (26%) groups. A retrospective analysis showed that at enrollment the treatment group in fact had larger tumors (greater than T3b-T3c: 35% vs. 18%), higher postop Gleason scores (8-9: 33% vs. 26%), more positive tumor margins (71% vs. 53%), and higher HER2/neu expression (IHC 3+: 35% vs. 19%). Of note, only 20% of the treated patients in this early trial received what is now considered the optimal dose of NeuVax, and none received a booster inoculation which has been shown subsequently to be beneficial.
BIO International Convention
Dr. Alton C. Morgan, President and CEO of Apthera, will present at the BIO Business Forum Thursday, June 19, from 2:00-2:15pm in Room 2. Dr. Morgan will discuss the NeuVax results in breast cancer and prostate cancer and future development plans for the product.
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 a privately held biopharmaceutical company with headquarters in Scottsdale, Arizona. For more information about the Company, visit www.apthera.com.
NeuVax is a HER2/neu-targeted peptide-based T-cell immunotherapy aimed at preventing disease recurrence and prolonging survival in cancer patients. Apthera licensed NeuVax from The University of Texas M. D. Anderson Cancer Center and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. Clinical studies conducted at Walter Reed Army Medical Center and Windber Medical Center have demonstrated that NeuVax reduces the rate of cancer recurrence while showing minimal side effects in early-stage breast cancer and prostate cancer. NeuVax is preferentially active in breast cancer patients with low expression of HER2, a patient population not served by Herceptin(R) therapy. NeuVax is being readied for evaluation in Phase III breast cancer.
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.
Posted: June 2008