SOURCE: Arbor Vita Corporation

September 19, 2011 07:30 ET

Arbor Vita Corporation Announces Promising Clinical Study Results Demonstrating High Specificity of First Available Human Papillomavirus (HPV) E6 Protein Diagnostic Test for Cervical Cancer and Precancerous Lesions

Large Study Evaluating Screening Tests Including HPV E6 Test for Cervical Cancer Screening; Interim Findings Presented at 27th International Papillomavirus Conference in Berlin, Germany

FREMONT, CA--(Marketwire - Sep 19, 2011) - Arbor Vita Corporation, a privately held company developing protein-based diagnostics and therapeutics focused on global diseases, announced today the presentation of interim clinical study results for the Company's HPV E6 Test for cervical cancer and precancerous lesions. Results from 3,179 out of 7,500 women enrolled in a clinical study in China validated the utility of using Arbor Vita Corporation's HPV E6 Test to detect the cancer-causing E6 protein, a biomarker for cervical cancer and precancerous lesions. The E6 oncoprotein is expressed at elevated levels in cervical swab samples only when HPV-infected cervical cells undergo precancerous and cancerous changes. By differentiating from HPV-infected cells not transitioning to cancer, the test can help focus scarce treatment resources on the women who need them most.

The START-UP (Screening Technologies to Advance Rapid Testing for Cervical Cancer Prevention - Utility and Program Planning) clinical study is funded by PATH, and is being conducted by the Chinese Academy of Medical Sciences (CICAMS). The study findings were presented at the 27th International Papillomavirus Conference (IPV) in Berlin, Germany by Fang-Hui Zhao, M.D., Ph.D., of the Cancer Institute and Hospital at CICAMS, Peking Union Medical College. Interim results and conclusions highlighted by Dr. Zhao included:

  • Arbor Vita Corporation's HPV E6 Test detected all the cancers in the study to date and, importantly, showed 99.0% specificity and 69.6% sensitivity as a primary test for CIN3+ (cervical intraepithelial neoplasia grade III or higher) precancerous lesions. This is an improvement over Visual Inspection with Acetic acid (VIA), which resulted in 94.1% specificity and 47.8% sensitivity in the same population. Pap smears historically have shown ~ 50% sensitivity for CIN3+.(1)
  • The HPV E6 Test demonstrated a 9-fold reduction in the referral rate for women requiring follow-up and/or treatment as compared to the Hybrid Capture 2 (HC2) HPV DNA Test. The HPV E6 Test referral rate was 1.5% vs. 14.3% for the HC2 HPV DNA Test.
  • The presentation concluded that Arbor Vita Corporation's HPV E6 Test could be viable for primary screening in low-resource settings or as triage in combination with established screening programs to minimize unnecessary procedures for follow-up and treatment.

Jose A. Jeronimo, M.D., Director of the START-UP Project at PATH, commented, "Arbor Vita Corporation's HPV E6 Test is unique. Its high specificity and ease of use make it potentially better than non-molecular screening tests such as VIA and Pap smears. The study findings suggest that the HPV E6 Test has applications in diverse settings. Importantly, it has the potential to increase access to screening for women worldwide and to reduce global deaths due to cervical cancer."

Dr. Jeronimo continued, "This is very exciting to us at PATH as the test comes closer to introduction. The START-UP program demonstrates our continued commitment to bringing affordable technologies to low-resource countries. News of our progress is timely in light of the recently announced partnership of the George W. Bush Institute, Komen Foundation, UNAIDS and others to reduce cervical cancer deaths worldwide."

Peter Lu, M.D., Arbor Vita Corporation's CEO, stated, "PATH's partnership with Arbor Vita Corporation represents an important model of collaboration to bring new technology and innovation to the market. It can overcome a persistent threat to women's health. As we anticipate final data from the clinical study, we will continue to reach out to potential partners to develop and commercialize the HPV E6 Test globally."

About the HPV E6 Test
Arbor Vita Corporation's HPV E6 Test detects the cancer-causing E6 protein, a biomarker for cervical cancer and precancerous lesions which is expressed at elevated levels in cervical swab samples only when HPV-infected cervical cells undergo precancerous and cancerous changes. The HPV E6 Test is in a non-invasive, easy-to-use "dipstick" format, requiring minimal infrastructure and technician training. It has low start-up costs, and test results are available in approximately 2-½ hours.

About 275,000 women die every year worldwide from cervical cancer, with approximately 80% of deaths in developing countries. Cervical cancer can be treated successfully when detected early. Introducing affordable screening programs with minimal infrastructure and training requirements will be the key to reducing mortality worldwide.

Initiated in 2008, the START-UP project is focused on the development of simple, rapid, portable, and robust biochemical tests that are inexpensive, acceptable to women and healthcare providers, safe, accurate, and appropriate for use in low-resource settings. The START-UP clinical study is enrolling a total of 7,500 women, aged 25-65, in three sites in China. The study is designed to compare specificity and sensitivity across multiple screening regimens, including VIA, Arbor Vita Corporation's HPV E6 Test and the HC2 HPV DNA Test. In addition, all individuals with a positive test will receive a one-year follow-up. Initial study results on all 7,500 women are expected by the end of 2011, with follow-up analysis in 2012.

PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH's work improves global health and well-being.

About Arbor Vita Corporation
Arbor Vita Corporation is a privately held company located in Fremont, California that was founded in 1998 to focus on the discovery, development and commercialization of a novel class of proteomic-based diagnostics and therapeutics. The Company's proprietary PDZ protein technology platform continues to produce groundbreaking solutions to complex health challenges, including infectious disease, cancer and neurological and cardiovascular disorders such as stroke.

(1) Nanda K, McCrory D, Myers E, Bastian L, Hasselblad V, Hickey J, et al. Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review. Ann Intern Med 2000;132(10):810-9.

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