Biomarker News and Research

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A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting.

14 Jun 2010

Olfactory function tests could help in treating patient in early stages of PD

A fast, simple and non invasive test of the ability to smell may be an important tool to screen people who are likely to develop Parkinson's disease, in which motor symptoms only become evident at a later stage of the disease, a German scientist will tell the annual conference of the European Society of Human Genetics today (Saturday).

14 Jun 2010

New guideline to improve IHC testing for expression status of ER and PgR in breast cancer issued

The College of American Pathologists and the American Society of Clinical Oncology today issued a joint guideline aimed at improving the accuracy of immunohistochemistry testing for the expression status of estrogen and progesterone receptors in breast cancer. The two groups conducted a systematic review of medical research literature in partnership with Cancer Care Ontario to develop the recommendations.

14 Jun 2010

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced data from a subgroup analysis of a Phase 2 randomized discontinuation trial showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell renal cell carcinoma (RCC) who had undergone a prior nephrectomy was 14.8 months.

11 Jun 2010

WaferGen announces microRNA, oncology gene panels for SmartChip Real-Time PCR System

WaferGen Biosystems, Inc., a leading developer of state-of-the-art genetic analysis systems, today announced the availability of two gene expression profiling panels for the SmartChip Real-Time PCR System that will enable microRNA and cancer pathway profiling capability.

10 Jun 2010

NanoString Technologies launches new solution to detect CNVs in human genomic samples

NanoString Technologies, Inc., a privately held life sciences company marketing a complete solution for detecting and counting large sets of target molecules in biological samples, today announced the launch of its early access program for a unique new solution that detects copy number variation in human genomic samples. The program was announced in conjunction with the company's participation in the European Human Genetics Conference in Gothenburg, Sweden.

From NanoString Technologies 10 Jun 2010

MicroConstants adds second Waters Xevo TQ MS system

MicroConstants, Inc., a bioanalytical and pharmacokinetic-specialty Contract Research Organization (CRO) in San Diego, California, announces the continued expansion of its bioanalytical capacity through the addition of a second Waters Xevo TQ MS system. The CRO has also appointed a new East Coast business development manager to actively pursue new business opportunities in that region.

10 Jun 2010

Protagen, Bayer Schering Pharma close cooperation contract for biomarker discovery in Endometriosis

Protagen AG, a specialist for in-vitro diagnostics and GMP-compliant protein analysis, and Bayer Schering Pharma AG, a global leading specialty pharmaceuticals company, announced today the closing of a cooperation contract for discovery of novel biomarkers in Endometriosis.

10 Jun 2010

Veracyte announces completion of Series B round

Veracyte, Inc. announced today the successful completion of its Series B round, a key milestone toward the company's first product launch later this year. The South San Francisco biotechnology company is committed to pioneering molecular cytology diagnostics to improve patient care and lower health care costs. This round was led by Domain Associates with significant participation from Veracyte's founding investors including Kleiner Perkins Caufield & Byers (KPCB), TPG Biotech (TPG), and Versant Ventures.

10 Jun 2010

Clinical Data raises $27.8 million through common stock public offering

Clinical Data, Inc. today announced that it has raised gross proceeds of approximately $27.8 million through the public offering of 1,945,576 newly issued shares of its common stock at a price of $14.30 per share. All of the shares are being offered by Clinical Data, Inc., which exhausts all remaining shares on its existing shelf registration statement.

9 Jun 2010

Correlogic Systems' OvaCheck blood test for detection of epithelial ovarian cancer receives CE Mark

Correlogic Systems, Inc. announced today that OvaCheck, the company's blood test for the detection of epithelial ovarian cancer, has fulfilled European Union regulatory requirements (CE marking) for distribution and sale of the test. The path is now cleared for the test to be made available to patients in Europe through their physicians.

9 Jun 2010

Covance opens state-of-the-art biorepository facility at Greenfield

Covance Inc., a leading provider of drug development services, announced today that it has opened a state-of-the-art biorepository facility at its Greenfield, Indiana location. The 20,000-square-foot building is dedicated to long-term storage of clinical trial specimens. The facility is able to store a wide-range of specimens, including plasma, serum, whole blood, DNA, PBMC, and tissue.

9 Jun 2010

Takeda Rika Kogyo to distribute WaferGen's SmartChip Real-Time PCR System in Japan

WaferGen Biosystems, Inc., a leading developer of state-of-the-art genome analysis systems, today announced the signing of an exclusive distribution agreement for the company's SmartChip Real-Time PCR System with Takeda Rika Kogyo Co., Ltd., a leading distributor of innovative products and services in the life science markets within Japan.

8 Jun 2010

Clarient granted U.K. patent for TLE3 biomarker

Clarient, Inc., a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that the United Kingdom Patent Office has granted a U.K. patent on the Company's TLE3 biomarker, a marker which may be used to predict which cancer patients will respond favorably to taxane therapy.

8 Jun 2010

$Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer$

Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer

Nektar Therapeutics today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 in women with platinum-resistant/refractory ovarian cancer. A total of 68 patients were enrolled with platinum-resistant disease, half of whom were platinum refractory. All 68 patients were evaluable for the primary endpoint of objective response rate using Gynecologic Cancer InterGroup criteria, which is a combination of response by tumor imaging (RECIST) and/or ovarian cancer biomarker (CA-125) criteria.

8 Jun 2010

$Progenics presents Phase 1 PSMA ADC therapy study data for taxane-refractory prostate cancer at ASCO 2010$

Progenics presents Phase 1 PSMA ADC therapy study data for taxane-refractory prostate cancer at ASCO 2010

Progenics Pharmaceuticals, Inc. today presented the design and rationale of an ongoing phase 1 trial of its prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) therapy at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO). This phase 1 trial is assessing the safety, tolerability and initial clinical activity of progressively increasing doses of PSMA ADC in patients with progressive, metastatic, hormone-refractory prostate cancer following prior taxane chemotherapy.

8 Jun 2010

Quintiles announces comprehensive suite of PI3K biomarker assays

Quintiles today announced a comprehensive suite of biomarker assays to help biopharmaceutical companies investigate the phosphoinositide 3-kinases (PI3K) cancer survival pathway, the focus of numerous anti-cancer therapies under development. Understanding the PI3K pathway is essential in developing new medicines to inhibit or block this pathway, thereby cutting off a metabolic function needed for certain cancers to survive.

8 Jun 2010

Adeona completes 50% enrollment in Part 2 CopperProof-2 study of oral zinc cysteine for Alzheimer's Disease

Adeona Pharmaceuticals, Inc. announced the completion of 50% enrollment in Part 2 of its clinical study, A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2).

7 Jun 2010

AMG 386 demonstrates antitumor activity in Phase 2 trial involving patients with recurrent ovarian cancer

Amgen today announced that AMG 386, combined with paclitaxel, demonstrated antitumor activity in a randomized Phase 2 trial involving 161 patients with recurrent ovarian cancer. The results are being presented for the first time in an oral presentation at the 2010 American Society of Clinical Oncology Annual Meeting.

7 Jun 2010

Genta reports combined data from Genasense Phase 3 trials for advanced melanoma

Genta Incorporated announced today the presentation of combined data on early endpoints from the Company's randomized Phase 3 trials of Genasense® (oblimersen sodium) Injection plus chemotherapy in patients with advanced melanoma. The presentation included a "pooled analysis" that assessed combined efficacy results for the endpoints of overall response and progression-free survival from both studies. The data were presented today at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.

7 Jun 2010

Biomarker News and Research

Further Reading

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Olfactory function tests could help in treating patient in early stages of PD

New guideline to improve IHC testing for expression status of ER and PgR in breast cancer issued

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

WaferGen announces microRNA, oncology gene panels for SmartChip Real-Time PCR System

NanoString Technologies launches new solution to detect CNVs in human genomic samples

MicroConstants adds second Waters Xevo TQ MS system

Protagen, Bayer Schering Pharma close cooperation contract for biomarker discovery in Endometriosis

Veracyte announces completion of Series B round

Clinical Data raises $27.8 million through common stock public offering

Correlogic Systems' OvaCheck blood test for detection of epithelial ovarian cancer receives CE Mark

Covance opens state-of-the-art biorepository facility at Greenfield

Takeda Rika Kogyo to distribute WaferGen's SmartChip Real-Time PCR System in Japan

Clarient granted U.K. patent for TLE3 biomarker

Phase 2 Study: NKTR-102 holds great therapeutic potential for women with platinum-resistant/refractory ovarian cancer

Progenics presents Phase 1 PSMA ADC therapy study data for taxane-refractory prostate cancer at ASCO 2010

Quintiles announces comprehensive suite of PI3K biomarker assays

Adeona completes 50% enrollment in Part 2 CopperProof-2 study of oral zinc cysteine for Alzheimer's Disease

AMG 386 demonstrates antitumor activity in Phase 2 trial involving patients with recurrent ovarian cancer

Genta reports combined data from Genasense Phase 3 trials for advanced melanoma

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