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Breast cancer is the most common type of cancer in women accounting for26% of female cancers. One in every eight women will develop breast cancer intheir lifetime, placing the lifetime risk at 13%. More than 200,000 new casesof breast cancer will be diagnosed in the United States in 2007 and upwards of2 million women are currently breast cancer survivors. Five-year survivalrates for breast cancer are 98% for localized disease, 83% for regionallyspread and 26% for distantly spread cancer. However, 25% of all metastasesoccur more than 5 years after the initial diagnosis and thus survival ratesdecrease as time goes out to 10 years due to disease recurrence. Methods todetect initial presentation of breast cancer as well as recurrence rely onimaging modalities, including mammography and MRI. No serum biomarkers havebeen approved for either primary breast cancer screening or monitoring fordisease recurrence primarily due to relatively low specificities andsensitivities. In asymptomatic women in remission from breast cancer theguidelines of the major oncologic organizations only suggest annualmammography for detection of new tumors.
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BC Detect(SM) measures levels of human aspartyl (asparaginyl) beta-hydroxylase (HAAH), a cancer molecular marker, in blood. HAAH has beendetected by immunohistochemical staining (IHC) in a broad range of cancersincluding breast cancer. In addition, HAAH protein levels in serum have beendemonstrated to be highly sensitive and specific for cancer in hundreds ofpatients with a range of cancer types, including breast cancer. Increasedlevels of HAAH have been found in the serum of 96% of women with breast cancer(n=157). In women not known to have cancer, HAAH was essentially undetectablein serum (n=32, specificity = 91%). HAAH was elevated in serum from womenwith all stages of breast cancer; mean serum HAAH levels for stages I - IVwere 19, 13, 21 and 15 ng/ml, respectively. In addition, serum from womencurrently in remission (n=35) following treatment for breast cancer were alsoanalyzed and found to be negative for HAAH.
"Measurement of serum HAAH levels using BC Detect(SM) has great promise asa diagnostic tool to monitor women with a history of breast cancer for diseaserecurrence", commented Pamela Jo Harris, MD, Vice President, Medical andClinical Affairs at Panacea. "BC Detect(SM), in conjunction with routinefollow-up imaging modalities should facilitate earlier identification ofrecurrent disease and prompt initiation of appropriate therapy."
About Panacea's Oncology Platform
In addition to BC Detect(SM), Panacea offers, PC Detect(SM), a diagnostictest used in conjunction with PSA and digital rectal exam to identify patientswith prostate cancer, LC Detect(SM), a diagnostic test to aide in thedetection of patients with lung cancer, and TK Sensesm, which determineswhether white blood cells from patients with chronic myelogenous leukemia(CML) are sensitive or resistant to imatinib, the therapy of first choice forCML patients, prior to initiation of therapy.
The HAAH serum assay will be further developed as a diagnostic test forother types of cancer. Panacea is also pursuing the development of antibodiesdirected against HAAH as novel agents for the treatment of cancer with liverc
