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Columbia University Medical Center Sponsors Clinical Study Using Biocept’s Liquid Biopsy Platform to Evaluate Cerebrospinal Fluid of Breast Cancer Patients for Metastatic Biomarkers

Biocept, Inc., a leading commercial provider of clinically actionable liquid biopsy tests designed to improve the outcomes of cancer patients, announces that Columbia University Medical Center will conduct a study to evaluate the clinical utility of the Company’s Target Selector™ platform to diagnose leptomeningeal metastases (LM) in patients with breast cancer.  LM occurs when tumor cells gain access to cerebrospinal fluid (CSF) pathways and regrow in distant sites within the spinal cord and brain leading to neurological complications. Biocept’s liquid biopsy platform will be used to test the CSF of breast cancer patients and will be compared to standard methods for confirming the diagnosis of LM.

Oncodesign has Entered into a Services Agreement with Eisai to Develop a New Personalized Medicine Program in Earlier Line Metastatic Breast Cancer Treatment

ONCODESIGN (FR0011766229 – ALONC), a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, recently announced the signing of an agreement with Eisai Inc. Oncodesign will conduct in vivo pharmacology studies and Eisai will provide gene expression profiling analysis using Oncodesign’s patient-derived xenograft models (PDX) to investigate the potential of eribulin mesylate (“eribulin”) in earlier line treatment of metastatic breast cancer.

bioTheranostics Signs Agreement with National PPO Network Prime Health Services

bioTheranostics, Inc., the leading genomic solutions provider for cancer diagnosis, recently signed a contract with Prime Health Services, Inc., a national preferred provider organization network, to cover the company’s genomic tests for breast cancer patients and patients with metastatic disease.

FDA Grants Genentech’s Perjeta Accelerated Approval for Use Before Surgery in People With HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin® (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

FDA Advisory Committee Recommends Accelerated Approval of Genentech’s Perjeta for Neoadjuvant Use in HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. The FDA will make a decision on whether or not to approve Perjeta for this use by October 31, 2013. If approved, the Perjeta regimen will be the first neoadjuvant breast cancer treatment approved in the United States and the first treatment approved based on pathological complete response (pCR) data, meaning there is no tumor tissue detectable at the time of surgery.

Perjeta is already approved in a number of countries including the United States for people with HER2-positive metastatic breast cancer (an advanced form of the disease in which the cancer has spread to other parts of the body).

The Perjeta application for neoadjuvant use follows a proposed new FDA pathway designed to more quickly bring promising medicines to people with earlier stages of breast cancer, where treatment may have a greater impact.

“More than 6,000 people in the United States die of HER2-positive breast cancer each year,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “The ODAC’s recommendation is a step toward bringing Perjeta to people with HER2-positive early stage breast cancer, where treatment can potentially prevent the disease from returning and spreading.”

Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working and may also reduce a tumor’s size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early stage breast cancer.

The ODAC recommendation was based on a review of results from NEOSPHERE and TRYPHAENA, two Phase II studies of Perjeta in high-risk, HER2-positive early stage breast cancer, as well as on longer-term safety data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer.

The ongoing Phase III APHINITY study will further evaluate Perjeta in the adjuvant setting (after surgery) and compares Perjeta, Herceptin® (trastuzumab) and chemotherapy with Herceptin and chemotherapy in people with HER2-positive early stage breast cancer. The study has completed enrollment with approximately 4,800 people, and the primary endpoint is invasive disease-free survival (IDFS). Genentech has proposed this study as a confirmatory study to the FDA. Data are expected in 2016.

Source: Genentech