PARK CITY, Utah, Sept. 17, 2014 /PRNewswire/ -- NuView Life Sciences, Inc. (NuView) announced entry into an exclusive global licensing and collaboration agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to further develop and commercialize NuView's investigative genomic-based diagnostic biomarker to detect cancers of the breast and prostate. The agreement also includes all other future diagnostic-imaging applications. NuView retains all rights for the VPAC1 compound for in-vivo therapeutic delivery and in-vitro urine screen applications.
Under the terms of the agreement, Otsuka will provide funding for all future clinical trials and commercialization of the VPAC1 biomarker worldwide. Otsuka intends to utilize NuView's manufacturing subsidiary, US Radiopharmaceuticals, Inc., to meet requirements for clinical trials through future commercialization upon approval. The two companies anticipate initiating a Phase I trial in the U.S. in the coming months. The VPAC1 biomarker originated at Thomas Jefferson University (TJU) Philadelphia, PA.
When regulatory approval is received, the VPAC1 biomarker will be utilized as a target-specific radiopharmaceutical in diagnostic Positron Emission Tomography (PET) imaging procedures.
The NuView VPAC1 Biomarker
NuView's VPAC1 biomarker, developed at Thomas Jefferson University by Dr. Mathew Thakur, has demonstrated significant diagnostic accuracy and sensitivity in preliminary studies by successfully binding only to cells indicative of cancer. Absence of the biomarker binding to a suspected cell or tumor would indicate that a patient may have another medical condition that is not cancer-related. The compound is labeled with a low-level radioactive ingredient, which is detected by a specialized medical imaging camera only if cancer is evident.
Based on preliminary human studies at TJU, NuView's VPAC1 agent may promptly demonstrate and inform physicians whether patients have breast, prostate cancers or not, diminishing over-diagnosis and unnecessary surgical biopsies.
Breast Cancer Statistics
Breast cancer in the United States is the most common cancer in women of all races or ethnicities. For Hispanic women, breast cancer is the most common cause of death from cancer, and it is the second most common cause of death in the U.S. among white, black, Asian/Pacific Islander, American Indian and Alaska Native women.1
In 2011, approximately 220,000 women and 2,000 men in the U.S. were diagnosed with breast cancer and approximately 41,000 women and 440 men died from the disease.2 Estimated new cases and deaths from breast cancer in the United States in 2014 are comprised of approximately 232,000 (female) and 2,300 (male) new cases, with 40,000 (female) and 430 (male) deaths.3 Suspicious mammogram findings can result in over-diagnosis and referring a patient for needle or surgical biopsy. However, it is estimated that four out of five breast biopsies are negative for cancer.4
Prostate Cancer Statistics
Prostate cancer is one of the most common cancers among men in the U.S. and is also one of the leading causes of cancer death among men of all races and populations. In 2011, approximately 209,000 men in the U.S. were diagnosed with prostate cancer and approximately 28,000 men died from the disease.5 Estimated new cases and deaths from prostate cancer in the United States in 2014 are comprised of approximately 230,000 new cases with 29,000 deaths.6
An elevated PSA test often results in a patient referred for a biopsy, which leads to a high percentage of benign pathological findings, almost identical to the findings following a suspicious mammogram and subsequent needle or surgical breast biopsies.
About NuView Life Sciences, Inc.
NuView is a privately held Utah-based biopharmaceutical company whose mission has been to identify and develop innovative solutions for the detection and treatment of cancer. The VPAC1 receptor, a member of the vasoactive intestinal peptide receptors (VIPRs), is overexpressed in the most frequently occurring malignant tumors and plays a major role in the progression and angiogenesis of a number of malignancies. NuView and TJU developed a peptide that specifically binds to the VPAC1 receptor only on mutating cells. The NLS-VPAC1 biomarker is a platform technology, and has relevance for in-vivo diagnosis, in-vivo-therapeutics and in-vitro urine screening applications. NuView has also developed a cancer proliferation imaging biomarker that may be useful for personalized treatment planning. For additional information about NuView Life Sciences, Inc., visit http://www.nuviewinfo.com.
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures, markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
Otsuka Pharmaceutical Co., Ltd., which employees approximately 28,700 people worldwide, is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group that is headquartered in Tokyo, Japan. The Otsuka Group has business operations in 25 countries and regions around the world with consolidated sales of approximately USD 14.1 billion for the fiscal year ended March 31, 2014. Otsuka Pharmaceutical welcomes you to visit its global website at https://www.otsuka.co.jp/en.
About Thomas Jefferson University
Thomas Jefferson University (TJU), the largest freestanding academic medical center in Philadelphia, is nationally renowned for medical and health sciences education and innovative research. Founded in 1824, TJU includes Sidney Kimmel Medical College one of the largest private medical schools in the country and ranked among the nation's best medical schools by U.S. News & World Report, and the Jefferson Schools of Nursing, Pharmacy, Health Professions, Population Health and the Graduate School of Biomedical Sciences. Jefferson University Physicians is TJU's multi-specialty physician practice consisting of the full-time faculty of JMC. Thomas Jefferson University partners with its clinical affiliate, Thomas Jefferson University Hospitals.
1 Centers for Disease Control and Prevention
2 Centers for Disease Control and Prevention
3 National Cancer Institute at the National Institutes of Health
4 US Department of Health and Human Services
5 Centers for Disease Control and Prevention
6 National Cancer Institute at the National Institutes of Health http://www.cancer.gov/cancertopics/types/prostate
SOURCE NuView Life Sciences, Inc.