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RBCC to Drive Growth Through Personalized Medicine

As part of its mission to capture a share of the fast-growing, $232 billion personalized medicine market, Rainbow Coral Corp. (OTCBB: RBCC) is making plans to empower patients to demand better care through a potent combination of innovation and education.

By delivering new technologies in the sectors of the personalized medicine field poised for the most growth—including companion diagnostics—RBCC hopes to arm patients with more effective and efficient treatment options than ever before. But bringing new ideas and products to the marketplace is only one piece of the company’s strategy for expansion, says RBCC CEO Patrick Brown.

“Our ultimate goal is to help spur patient-driven demand for personalized medicine,” Brown said. “That requires not just delivering new innovations, but helping to educate patients on these promising new treatment options. That’s why we’re developing a comprehensive media and marketing strategy.”

The personalized medicine market in the U.S. is ripe for expansion, with PricewaterhouseCoopers predicting that the sector could grow to as much as $452 billion by 2015. One of the fastest-growing fields in the market is companion diagnostics, which could grow to as large as $42 billion by 2015, according to industry analysts TriMarkPublications.com.

RBCC has formed a biotech subsidiary, Rainbow BioSciences, to market and develop new medical and research technology innovations to compete alongside companies such as Bristol Myers Squibb Co. (NYSE: BMY), Biogen Idec Inc. (NASDAQ: BIIB), Abbott Laboratories (NYSE: ABT) and Amgen Inc. (NASDAQ: AMGN).

Source: Business Wire

Nektar Presents Target-Specific Biomarkers Being Assessed in Ongoing Phase 3 BEACON Study of Etirinotecan Pegol for the Treatment of Metastatic Breast Cancer at the 2013 American Society of Clinical Oncology Annual Meeting

Nektar Therapeutics (NASDAQ:NKTR) recently announced that it presented a series of target-specific biomarkers that are being evaluated in the development of etirinotecan pegol for the treatment of breast cancer. Etirinotecan pegol is a unique, next generation, targeted topoisomerase I inhibitor currently in Phase 3 clinical development as a potential treatment for patients with locally recurrent or metastatic breast cancer. The BEACON (BrEAst Cancer Outcomes with NKTR-102) Phase 3 Study is a randomized, open-label, international study that is evaluating single agent etirinotecan pegol in patients who have previously received an anthracycline, a taxane and capecitabine (ATC) versus a comparator arm consisting of an active single agent treatment of physician’s choice (TPC).

“One of our objectives in treating metastatic breast cancer is to prospectively identify patients that will respond to specific treatments so they can achieve the optimal individualized care,” said Hope Rugo, M.D., Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Comprehensive Cancer Center and Member of the BEACON Study investigator steering committee. “The goal of evaluating these important biomarkers in patients enrolled into the BEACON study is to help us understand which breast cancer patients might have the best clinical outcomes from treatment with etirinotecan pegol.”

A series of assays for target-specific pharmacodynamic biomarkers for etirinotecan pegol, including the molecular target topoisomerase I, have been established and are being measured in the Phase 3 BEACON study. The biomarkers were identified from Circulating Tumor Cell (CTC) samples which were collected prior to patient treatment. Additional CTC patient samples are being collected at regular intervals during treatment and at the end of treatment. Preliminary results from the initial pre-dose samples found CTCs in over 90% of patient samples, with a median of 200 CTCs per 7.5 mL blood draw. Patient participation in the CTC sub-set of the BEACON study is projected to be over 75%. Measurements of each biomarker expression over time will be analyzed in order to identify potential predictive biomarkers for clinical response to etirinotecan pegol.

“We are pleased to have identified several baseline pharmacodynamic biomarkers, which are target-specific such as topoisomerase 1, and which can be reliably measured over the patient’s treatment period,” said Robert Medve, M.D., Chief Medical Officer of Nektar Therapeutics. “The measurement of these biomarkers in the BEACON study will help us understand and shape the future treatment of patients with etirinotecan pegol. Enrollment in the BEACON study is well ahead of schedule and we expect to complete the target enrollment of 840 patients in the third quarter of 2013.”

Circulating Tumor Cells are cancer cells shed from either the primary tumor or its metastases that circulate in the peripheral blood. CTCs are emerging tumor biomarkers, collected through a minimally invasive blood draw, providing a “liquid” biopsy sample and allowing for post-treatment monitoring of the patient. CTCs provide well-defined targets for the understanding of tumor biology and tumor cell dissemination, which offers a unique approach to identify novel therapeutic targets and understand resistance to established therapies.

Source: Nektar Therapeutics

Alzheimer’s Markers Predict Start of Mental Decline

Scientists at Washington University School of Medicine in St. Louis have helped identify many of the biomarkers for Alzheimer’s disease that could potentially predict which patients will develop the disorder later in life. Now, studying spinal fluid samples and health data from 201 research participants at the Charles F. and Joanne Knight Alzheimer’s Disease Research Center, the researchers have shown the markers are accurate predictors of Alzheimer’s years before symptoms develop.

“We wanted to see if one marker was better than the other in predicting which of our participants would get cognitive impairment and when they would get it,” said Catherine Roe, PhD, research assistant professor of neurology. “We found no differences in the accuracy of the biomarkers.”

The study, supported in part by the National Institute on Aging, appears in Neurology.

The researchers evaluated markers such as the buildup of amyloid plaques in the brain, newly visible thanks to an imaging agent developed in the last decade; levels of various proteins in the cerebrospinal fluid, such as the amyloid fragments that are the principal ingredient of brain plaques; and the ratios of one protein to another in the cerebrospinal fluid, such as different forms of the brain cell structural protein tau.

The markers were studied in volunteers whose ages ranged from 45 to 88. On average, the data available on study participants spanned four years, with the longest recorded over 7.5 years.

The researchers found that all of the markers were equally good at identifying subjects who were likely to develop cognitive problems and at predicting how soon they would become noticeably impaired.

Next, the scientists paired the biomarkers data with demographic information, testing to see if sex, age, race, education and other factors could improve their predictions.

“Sex, age and race all helped to predict who would develop cognitive impairment,” Roe said. “Older participants, men and African Americans were more likely to become cognitively impaired than those who were younger, female and Caucasian.”

Roe described the findings as providing more evidence that scientists can detect Alzheimer’s disease years before memory loss and cognitive decline become apparent.

“We can better predict future cognitive impairment when we combine biomarkers with patient characteristics,” she said. “Knowing how accurate biomarkers are is important if we are going to some day be able to treat Alzheimer’s before symptoms and slow or prevent the disease.”

Clinical trials are already underway at Washington University and elsewhere to determine if treatments prior to symptoms can prevent or delay inherited forms of Alzheimer’s disease. Reliable biomarkers for Alzheimer’s should one day make it possible to test the most successful treatments in the much more common sporadic forms of Alzheimer’s.

Study: Amyloid imaging and CSF biomarkers in predicting cognitive impairment up to 7.5 years later

Source: EurekAlert!

Matrix-Bio Signs Metabolomics Biomarker Licensing Agreement with Quest Diagnostics for Development of Breast Cancer Recurrence Test

Matrix-Bio Inc., a diagnostics company that uses metabolite profiling to detect cancer and other diseases, recently signed an exclusive global licensing and marketing agreement for metabolomic biomarkers with Quest Diagnostics (NYSE: DGX).

CellHealth Institute Launches with Support from Influential Investors

CellHealth™ Institute (CHI), a new biotechnology company that provides breakthrough products, services and lifestyle education in the emerging category of personalized cell health recently launched with the backing of key investors. John Malone Ph.D., chairman of Liberty Media Corporation (NASDAQ: LMCA) has invested $2 million in CellHealth Institute.

CellHealth Institute offers fully integrated and individualized health programs, paired with scientific biomarker evaluations, medical-grade supplements and informed advice for its clients and social community on healthy lifestyle choices to improve cell health. CellHealth Institute also provides advanced adult stem cell services, and has its own cell technology IP portfolio.

“The development of adult stem cell research and technology and the exciting progress in the world of cell health and regenerative medicine are the things that motivated me to invest in CellHealth Institute,” said John Malone . “We know unequivocally that damage to human cells is at the core of most disease. We have a duty to research, develop and deliver to the doors of people across the United States and worldwide the products and services that can increase and enrich their quality of life. I believe that CellHealth Institute and the work of its team will lead us into the new frontier of preventative care and I’m excited to be a part of the progress that is being made.”

The support of investors, including Mr. Malone, will enable CellHealth Institute to grow its research and product development plans as well as its consumer-facing strategy. CellHealth Institute, which is led by cell health expert and Chief Medical Officer Dr. Vincent Giampapa, the world’s first board-certified anti-aging physician, will also continue to collaborate with top-tier universities and publicly traded companies in its research of advanced adult stem cell treatments.

“It is extremely gratifying to have John Malone , someone well recognized as having extraordinary business acumen with continuing success in many industries, so committed to our movement and the things we’re trying to achieve,” said David Saloff , chief executive officer of CellHealth Institute. “The concept of cell health is a new one to most people, but we want to ensure that it becomes widely understood and fast. The presence of exceptional visionaries like John Malone can only help us achieve our outreach with excellence.”

Mr. Malone is joined in support of CellHealth Institute by Ed Bosarge , founder and CEO of Capital Technologies Inc. Dr. Bosarge, through the Bosarge Family Office, has funded CellHealth Institute’s latest clinical study into reprogramming aging adult stem cells at the University of Medicine and Dentistry New Jersey (UMDNJ).

Source: PR Newswire