SCOTTSDALE, AZ--(Marketwire - June 25, 2009) -
Apthera, Inc. today announced that it
reached an agreement with the U.S. Food and Drug Administration (FDA) under
a Special Protocol Assessment (SPA) for its planned Phase III clinical
trial of the Company's lead drug, NeuVax. The SPA is a written agreement
between the trial's sponsor and the FDA regarding the design, endpoints,
and planned statistical analysis of the Phase III trial to be used in
support of a Biologics License Application (BLA).
The SPA approval letter was received from the FDA on June 19, 2009,
concluding a 21-month reiterative process between Apthera, the breast
oncology community in the U.S. and the Agency.
Chief Medical Officer, William E. Gannon, M.D., said, "We would like to
thank FDA reviewers for their input and guidance during the SPA approval
process and are pleased that the Agency has indicated an agreement to
proceed with the Phase III protocol." The multicenter, double-blind,
randomized pivotal trial is expected to enroll 700 women diagnosed with
HER2/neu-expressing tumors and who have completed standard of care
consisting of surgery, chemotherapy and radiotherapy. Women must have a
common HLA haplotype (HLA-A2 or -A3) and must agree to be followed for 5-10
years. The primary endpoint of the study is disease-free survival (DFS) as
determined by disease recurrence or death from any cause, and the first
analysis of the data will occur after 70 recurrence events or approximately
3 years from the start of the study.
Alton C. Morgan, Ph.D., President and CEO, added, "The positive outcome of
the SPA process means Apthera has reached a major developmental milestone
for NeuVax. With regulatory approval of the design of the pivotal trial,
this achievement has created a value inflection milestone for both the
product and the Company."
Apthera, Inc. is a privately held, Arizona-based biotechnology company
developing a pipeline of peptide-based immunotherapies for cancers that
express HER2/neu, a well-validated and established oncology target. The
Company's lead product, NeuVax, contains the E75 peptide which is one of
the rare T-cell peptides that has been documented to elevate or boost
pre-existing anti-cancer immunity in cancer patients. High-level immune
responses in patients administered NeuVax are consistent with recall
responses of T-cells. NeuVax's initial indication is for early-stage breast
cancer patients who don't qualify for trastuzumab (Herceptin®) therapy.
For more information about the Company visit www.apthera.com.
This news release contains forward-looking statements. 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.