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ApoCell Announces Delivery of First Prototypes of ApoStream Circulating Tumor Cell (CTC) Isolation Technology to National Cancer Institute

ApoCell, Inc. recently announced that the first prototypes of its ApoStream™ circulating tumor cell (CTC) isolation system have been delivered to select investigator sites including SAIC-Frederick Inc. (SAIC-F) in support of the National Cancer Institute (NCI). The delivery is part of a $2.9 million subcontract awarded to ApoCell in Q1-2011 by SAIC-F to develop a device capable of isolating live cancer cells from small volumes of blood. While ApoStream™ has been used in ApoCell’s laboratories since 2010; this first external placement of the technology is a significant milestone in the company’s plan to commercially offer the device as a vital tool in the development of targeted therapies for the prevention and treatment of cancer.

“The NCI research environment has provided an ideal first external placement for ApoStream™ and the performance of the device to date has been consistent with our own findings,” said Darren Davis , ApoCell president and CEO, adding that results were presented at the Molecular Medicine Triconference on February 15, 2013. ApoCell has shipped four ApoStream™ prototypes to NCI and will deliver a total of 12 by year end, Davis said.

ApoCell has incorporated ApoStream™ into a number of ongoing early and late stage clinical trials as part of the company’s service offering. The recent external placement of ApoStream™ prototypes enables the company to begin its beta-testing program for third party validation of the technology. ApoCell is now looking to place ApoStream™ prototypes at additional investigator sites around the world as part of the beta testing phase. The company plans to commercially launch the technology for research-use-only in 2014.

CTCs have long been known to exist in cancer patients’ blood and clinical correlations have been established between CTC counts and disease progression. These circulating cells represent an attractive target for clinicians seeking to assess a patient’s disease state; however the clinical promise of using CTCs to select appropriate treatments and monitor effectiveness has yet to be fully realized. One reason is that CTCs are extremely rare and difficult to isolate using the commercially available technologies, many of which rely on antibodies that attach to specific cancer cell antigens such as EpCAM.

ApoStream™ is antibody independent and utilizes a process known as dielectrophoresis (DEP) field-flow assist. The technology employs a non-uniform electrical field at specific frequencies to separate viable cancer cells from normal blood cells by relying on a cancer cell’s unique form and structure rather than surface antigen expression. ApoStream™ has been shown to detect significant quantities of intact CTCs from a wide range of cancer types, enabling more robust downstream analysis for greater understanding of each patient’s disease.

After the commercial launch of the research-use-only instrument, Davis said ApoCell plans to continue developing ApoStream™ technology for a clinical point-of-care device that would provide oncologists with more effective monitoring of targeted therapies for various cancer types. The company’s goal is to launch a clinical instrument in 2016.

“We believe ApoStream can play a significant role in the evolution of personalized cancer treatment,” Davis said.

Source: PR Newswire

CvergenX, Inc. Partners with National Cancer Institute to Develop New Test to Predict Radiation Therapy Success

A molecular signature index technology that can lead to better radiation therapy decisions for patients with cancer is being developed into a reliable radiosensitivity test by CvergenX, Inc., an advanced cancer diagnostics company. It is being done in conjunction with the National Cancer Institute’s Clinical Assay Development Program (CADP).

Research collaborations between CvergenX and Moffitt Cancer Center have preliminary data on the molecular signature’s efficacy in trials for patients with rectal, esophageal, head and neck cancers and, most recently, for patients with breast cancer. The NCI has selected the technology, called InterveneXRT ™, for further development and validation in a commercial collaboration agreement with CvergenX with the aim of making an assay that is ready for use in clinical trials and approval by the U.S. Food and Drug Administration.

To date, the technology has been developed and correlated with retrospective clinical outcomes over more than seven years of research and with the help of more than $2 million in funding primarily from the NCI.

“Developing a radiosensitivity predictive assay has been a goal of radiation biology for decades,” said Javier F. Torres-Roca, M.D., a member of the Radiation Oncology, Chemical Biology and Molecular Medicine Programs at Moffitt and co-founder and chief scientific officer of CvergenX. “This effort supports the emphasis on personalized medicine, where the goal is to use molecular signatures to guide therapeutic decisions.”

According to Torres-Roca, approximately 60 percent of all cancer patients receive radiotherapy during their treatment. Until now, no molecular diagnostic or biomarker for radiosensitivity had been developed to predict its benefit. Once the assay is fully developed, Intervene XRT ™ may reduce the need for radiation therapy when the assay shows which patients will or will not respond to treatment.

The radiosensitivity molecular signature was originally developed based on gene expression for 10 specific genes and a linear regression algorithm. It was developed in 48 cancer cell lines using a systems-biology strategy focused on identifying biomarkers for cellular radiosensitivity.

The initial effort is focused on rectal cancer where preoperative radiotherapy is part of the standard of care for patients with stage 2 or 3 disease. However approximately 40 percent of patients do not experience a clinical response to pre-operative treatment. The CADP goal is to show whether this assay will “identify patients who will not benefit from preoperative chemoradiation (with 90 percent negative predictive value), enabling physicians to make informed decisions about the use of chemoradiation for these patients.”

The work will be done by the Clinical Assay Development Network, a nationwide network of CLIA certified labs (labs conforming to the Clinical Laboratory Improvements Amendments, 1988) who have placed a bid with the NCI to carry out the project. The NCI will provide the financing, expertise and labor for the assay development.

According to Mary Del Brady, chairman and CEO of CvergenX, the individualization of radiation therapy is an important component of personalized cancer treatment.

“We are the first commercial enterprise to develop a companion diagnostic to radiation therapy, joining a growing group of personalized medicine companies that are applying genomics-based analysis to clinical practice,” said Brady. “Our goal is to have a validated test with proven clinical utility in the marketplace within the next three years. The test will provide more information, and far greater accuracy, than oncologists have ever had, enabling them to adjust their clinical management for better outcomes for their patients.”

Source: Business Wire

Horizon Discovery Establishes Three New Centers of Excellence in Asia

Horizon Discovery (Horizon), a leading provider of research tools to support the development of personalized medicines, recently announced it has established three new Centers of Excellence (CoE’s) for gene editing in Asia. The new Centers are at Aichi Cancer Center, Japan, Seoul National University, South Korea, and the National Cancer Centre (NCC), Singapore. Horizon will support the three research centers in their application of its proprietary gene engineering technology, GENESIS™, to generate human isogenic cell lines harboring specific genes/mutations relating to cancer.

“We are delighted these three new institutes have joined our Centers of Excellence program,” said Dr Rob Howes, Principal Scientist, Horizon. “We are excited to continue expanding our rAAV genome editing network into Asia, and hope to add to this further through 2013.”

The Aichi Cancer Center is Horizon’s second CoE in Japan, and will focus on elucidation of the molecular mechanisms of viral proliferation and oncogenesis of Epstein Barr Virus, as part of the world-wide effort to combat virally-initiated cancers. The principal investigator for this program will be Dr. Takayuki Murata.

Seoul National University, Institute of Molecular Biology and Genetics, will work with Horizon to create isogenic cell lines to study the regulatory mechanisms of BubR1 spindle assembly checkpoint, in order to increase understanding of the basis of genetic instability of cancer. Associate Professor Hyunsook Lee will be leading the program for Seoul National University.

Dr Daniel SW Tan, PI at the NCC Singapore, Department of Medical Oncology, will use Horizon’s technology to study the effects on cell lines of cancer-causing EGFR mutations, which are implicated in a wide range of cancer types.

These centers become part of the larger Horizon Centers of Excellence network, which includes high profile Institutions such as Cambridge University, UCL, Yale University, Washington University in St Louis, the NCI in Bethesda, and the National Cancer Centre, Japan.

Source: Business Wire

Mesothelioma Drug Slows Disease Progression in Patients with an Inactive NF2 Gene

Preliminary findings from the first trial of a new drug for patients with mesothelioma show that it has some success in preventing the spread of the deadly disease in patients lacking an active tumour suppressor gene called NF2. The study is presented at the 24th EORTC-NCI-AACR [1] Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland, today (Friday) [2].

NextBio Teams With Emory University for Cancer Biomarker Discovery

NextBio recently announced a partnership with Emory University and its Winship Cancer Institute using genomic data to identify unique biomarkers and treatments for patients with multiple myeloma. The centerpiece of the partnership is a translational research study that will use NextBio Clinical to interpret molecular data from patients with multiple myeloma, with the ultimate goal of making new discoveries that will improve the care of patients with refractory and relapsed forms of myeloma. These forms of myeloma, a plasma cell cancer that constitutes about 1% of all cancers in the United States, have been particularly challenging to treat.