美国商业资讯2006年12月14日圣安东尼奥消息——

医学博士COL George E. Peoples展示了HER2/neu疫苗二期临床试验取得的积极成果。这种疫苗的基础是一种名为E75的致免疫肽，是为了采取免疫疗法治疗乳腺癌和其它有HER2/neu表现的癌症而开发的。这条临床最新信息是马里兰州贝塞斯达的美国军队卫生服务大学（Uniformed Services University of the Health Sciences）癌症疫苗开发实验室主任Peoples博士在2006年圣安东尼奥乳腺癌研讨会上公布的。

COL Peoples目前担任圣安东尼奥布鲁克陆军医学中心（Brooke Army Medical Center）肿瘤外科主任。他从约翰?霍普金斯大学获得医学士学位，在哈佛大学布莱根妇女医院（Brigham & Women's Hospital）完成了外科住院医师实习，在德州大学安得森癌症中心（UTMDACC）完成研究工作。在就任现职之前，他多年担任Walter Reed陆军医学中心（Walter Reed Army Medical Center）肿瘤外科主任。他在基于肽的癌症疫苗研究领域广泛发表文章，刊登在《癌症》（Cancer）、《美国国家科学院院刊》（National Academy of Sciences）、《临床肿瘤学杂志》（Journal of Clinical Oncology）、《临床癌症研究》（Clinical Cancer Research）。他获得数百万美元的研究资助，在15项以上的疫苗和免疫疗法临床试验中担任研究负责人。

关于此次研究

E75是在德州大学安得森癌症中心发现的一种致免疫肽，从HER2/neu蛋白质衍生而来。这种蛋白质在许多乳腺癌（BC）患者中都出现了过度表达的现象。E75用作疫苗，采用GM-CSF（sargramostim或Leukine(R)）作为免疫佐剂，与这种肽混合；以月为单位皮下用药，持续治疗六个月。研究中安排了两组平行对照试验，分析E75预防乳腺癌复发的效果。淋巴结阳性（NP）乳腺癌患者参加一项考察疫苗安全性的研究；淋巴结阴性（NN）乳腺癌患者则参加另一项有关剂量优化的研究。所有患者均接受了标准的外科治疗和医学处理，参与研究之前无疾病。

免疫反应是采用体外功能分析和体内迟发型超敏（DTH）反应来监测的。对两组试验的临床复发率都进行紧密的跟踪。

迄今为止共有171名患者参加了这两组研究，其中90人参加淋巴结阳性组试验，81人参加淋巴结阴性组试验。试验开始后，对患者进行了HLA分型；A2和A3阳性患者分到疫苗组，其它HLA类型的患者分到观察组。共有90名患者接受了疫苗，另外81人则参加此次研究的观察小组。试验的毒性极其微弱，I级局部反应占86％，II级局部反应占14％。从系统毒性来看，只有16％为0级，70％为I级，13％为II级，1％为III级，主要由GM-CSF引起。接种了疫苗的患者免疫后均表现出体外免疫反应，也表现出体外DTH反应，不过有些不稳定。这时，接种了疫苗的患者，24个月的临床复发率为5.6％（5/90），而观察组（p=0.04）则为14.8％（12/81）。

未来发展

该产品已进入后期开发阶段，一期和二期试验取得了积极的结果，根据这一情况，Apthera, Inc.从德州大学安得森癌症中心（UTMDACC）和Henry M. Jackson军用医药发展促进基金会（HJF）获得E75的独家授权。美国军队卫生服务大学（USU）是美国国防部和马里兰州非盈利企业——HJF基金会下属的高等教育机构，管理“技术转让联合办公室”。此外，Apthera公司与HJF基金会/美国军队卫生服务大学签署了“合作研究开发协议”，与Peoples博士继续合作，进一步开发E75和其它有发展前景的疫苗。

关于Apthera, Inc.

Apthera, Inc.是一家私人公司，成立于2005年7月，旨在获得知名学术机构的授权，开发处于后期临床试验阶段的癌症免疫疗法，并进行商业推广。Apthera公司第一个业务重点是为E75（现称为NeuVax(TM)）融资，完成产品最后阶段的开发。Apthera公司经授权使用的技术的基本内容是，利用单独的免疫刺激肽（如E75）和肽化合物激活多个“杀手”T细胞克隆，应对多个肿瘤抗原表位。在微小残留疾病临床条件下，这种新型辅助治疗法能减少疾病的复发，提高长期癌症患者存活率。Apthera公司持有自然出现的人类白细胞抗原（HLA）肽、使用方法、成分、改进、工艺的相关专利，对其实行严密的专利保护。公司的主打产品NeuVax(TM)准备投入第三期研究，用于乳腺癌、前列腺癌以及其它出现HER2/neu表达的肿瘤的辅助治疗。根据临床试验初期取得的成功，公司现计划与美国食品药品管理局召开第二期临床试验期末会议，讨论“特别临床试验方案评估”（SPA），设计、组织大规模的乳腺癌适应症随机三期关键注册研究。如需了解Apthera公司详细情况，请访问：http://www.apthera.com 。

总裁的评价

Apthera公司总裁兼首席执行官Joseph Sinkule博士评价说，“Peoples博士展示了癌症疫苗和免疫疗法领域一项有积极意义的重大研究。这些受控研究所取得的综合成果真的让人很振奋。” NeuVax(TM)可以安全服用，毒性极小。体外功能分析和体内迟发型超敏（DTH）反应均显示了对该疫苗的持续免疫反应。看来，NeuVax(TM)能够显著降低采用传统方法治疗的乳腺癌患者的疾病复发率。“我们认为，这种疫苗可以用作新型安全有效的辅助治疗，协助现有标准疗法，降低乳腺癌复发率。我们在计划继续进行第三期临床试验，准备开展商业开发，将该产品用于乳腺癌及前列腺癌、卵巢癌、肺癌等其它癌症适应症，对目前的进展，我们感到很高兴。”

本新闻稿包含美国1995年《私人证券诉讼改革法案》界定的前瞻性表述。这些表述并非历史性事实，涉及风险和不确定性，这些因素可能造成实际结果以及某些事件发生的时间与本文表述或暗示的情况产生重大差异，其中包括但不限于，与临床开发、监管审批、产品商业化、知识产权索赔诉讼相关的风险，以及与公司提出的活动相关的风险。

联系方式：Apthera Inc. Gail Thurston，800-254-4841 或者 001-480-882-8841 business@apthera.com

(BW)(TX-APTHERA) Positive Phase II Clinical Trial Results with HER2/neu Vaccine

SAN ANTONIO--(BUSINESS WIRE)--Dec. 14, 2006--

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.

CONTACT: Apthera Inc. Gail Thurston, 800-254-4841 or 001-480-882-8841 business@apthera.com