Positive Phase II Clinical Trial Results with HER2/neu Vaccine
COL George E. Peoples, M.D. presented positive clinical results
from a HER2/neu vaccine based on an immunogenic peptide called E75
developed for the immunotherapy of breast cancer and other
HER2/neu-expressing cancers. The clinical update was presented at the
2006 San Antonio Breast Cancer Symposium by Dr. Peoples, Director,
Cancer Vaccine Development Lab, Uniformed Services University of the
Health Sciences, Bethesda, Md. (USU).
COL Peoples, now Chief of Surgical Oncology at Brooke Army Medical
Center in San Antonio, received his medical degree from Johns Hopkins,
completed a surgical residency at Harvard's Brigham & Women's
Hospital, completed a fellowship at The University of Texas M. D.
Anderson Cancer Center (UTMDACC), and was Chief of Surgical Oncology
at Walter Reed Army Medical Center for several years prior to assuming
his current position. He is widely published in the area of
peptide-based cancer vaccines in journals that include Cancer,
Proceedings of the National Academy of Sciences, Journal of Clinical
Oncology, and Clinical Cancer Research. He has received several
million dollars in grants and has been the principal investigator in
more than 15 vaccine and immunotherapy clinical trials.
About the Study
E75 is an immunogenic peptide discovered at UTMDACC and derived
from the HER2/neu protein which is over-expressed in many breast
cancer (BCa) patients. E75 is administered as a vaccine consisting of
the peptide mixed with GM-CSF (sargramostim or Leukine(R)) as an
immunoadjuvant and administered intradermally on a monthly basis for
six months. Two parallel trials of E75 for the prevention of breast
cancer recurrence have been conducted. Patients with node positive
(NP) BCa have been enrolled in a study to determine vaccine safety,
while node negative (NN) patients have been enrolled in a study for
dose optimization. All patients underwent standard surgical and
medical treatment and are rendered disease-free prior to enrollment.
Immunologic response is monitored using in vitro functional assays as
well as in vivo DTH responses. Clinical recurrence rates in both
trials have been followed closely.
A total of 171 patients have been enrolled thus far in both
studies with 90 in the NP trial and 81 in the NN trial. Following
enrollment, patients are HLA typed; A2 and A3 positive patients are
then placed in the vaccine arm while all other HLA types are placed in
the observation arm. A total of 90 patients have received the vaccine
while 81 are in the observation arm of the study. Toxicity has been
minimal with local reactions being 86% Grade I and 14% Grade II.
Systemic toxicity has been only 16% Grade 0, 70% Grade I, 13% Grade
II, and 1% Grade III and mainly attributable to the GM-CSF. All
vaccinated patients have demonstrated in vivo immunologic responses as
well as in vivo DTH responses post-vaccination though variable. At
this point, clinical recurrence rates at 24 months are 5.6% (5/90) for
vaccinated patients versus 14.8% (12/81) for the observation group
(p=0.04).
Future Development
Based on the advanced development stage of this product and the
promising Phase I and Phase II results, Apthera, Inc. has exclusively
licensed E75 from UTMDACC and The Henry M. Jackson Foundation for the
Advancement of Military Medicine, Inc. (HJF). USU, an institution of
higher education within the United States Department of Defense and
HJF, a non-profit Maryland corporation, operate a Joint Office of
Technology Transfer. Additionally, Apthera is establishing a
Cooperative Research and Development Agreement with HJF/USU to
continue working with Dr. Peoples for the further development of E75
and other promising vaccines.
About Apthera, Inc.
Apthera, Inc. is a private company established in July 2005 to
develop and commercialize advanced-stage clinical programs in cancer
immunotherapy licensed from renowned academic institutions. Apthera's
initial focus is on funding and completing the final phases of
development of E75 (now called NeuVax(TM)). Apthera's licensed
technology is based on the use of single immunostimulatory peptides,
such as E75, and peptide combinations to activate multiple "killer"
T-cell clones against multiple tumor antigen epitopes. This new
adjunct therapy, in a clinical setting of minimal residual disease,
will result in less disease recurrence and improved long-term cancer
survival. Apthera has patents and strong proprietary protection on the
naturally presented human leukocyte antigen (HLA) peptides, methods of
use, compositions, modifications, and processes. The Company's lead
product, NeuVax(TM) is being readied for Phase III studies and
indicated for the adjuvant treatment of breast and prostate cancers,
and other HER2/neu-expressing tumors. Based upon the early success
achieved in the clinic, the company now plans an end-of-Phase II
meeting with FDA to discuss a Special Protocol Assessment (SPA) and
the design and conduct a large, randomized, pivotal Phase III
registration study for the breast cancer indication. To learn more
about Apthera, please visit http://www.apthera.com.
From the President
Dr. Joseph Sinkule, President and CEO of Apthera commented, "Dr.
Peoples has presented a positive, landmark study in the field of
cancer vaccines and immunotherapies. The combined results obtained in
these controlled studies are truly exciting." NeuVax(TM) can be
administered safely and with very minimal toxicity. Both in vitro
functional assays and in vivo DTH responses indicate a sustained
immunologic response to the vaccine. NeuVax(TM) appears to
significantly reduce the rate of recurrence in conventionally treated
breast cancer patients. "We believe that this vaccine may represent a
new, safe and useful adjunct to current standard therapy in reducing
the rate of breast cancer recurrence. We are pleased to be planning
the continuation of Phase III and commercial development of this
product for breast cancer and other cancer indications, such as
prostate cancer, ovarian cancer, and lung 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.