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.