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MONITORING FORCE files for Flibanserin orphan drug status designation with the EMEA

MONITORING FORCE GmbH announced that they have filed on November 16th, 2009 Flibanserin in the indication treatment-relevant levodopa-induced dyskinesia in Parkinson's disease for orphan drug status designation with the European Medicines Agency (EMEA). Levodopa-induced dyskinesia is a complication of the mainstay treatment in advanced Parkinson's and a serious burden to some of those affected, since it may be disabling for the patients and preventing them from receiving optimal treatment for Parkinson's.

19 Nov 2009

Advanced Cell Technology files an IND with the FDA for study using embryonic stem cells to treat SMD

Advanced Cell Technology, Inc. announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD). Among the most common causes of untreatable blindness in the world are degenerative diseases of the retina.

19 Nov 2009

Aegera Therapeutics commences AEG35156 Phase 2B study for AML

Aegera Therapeutics Inc. announced today the dosing of the first patient in a randomized Phase 2B study of AEG35156, a targeted antisense therapeutic in mid-stage development for multiple oncology indications.

19 Nov 2009

Cardiovascular Systems commences patient enrollment in CALCIUM 360° clinical trial

Cardiovascular Systems, Inc., announces the first patient enrollment in its prospective, randomized CALCIUM 360° clinical trial, part of the company’s 360° Clinical Series. The CALCIUM 360° study will evaluate the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI’s Diamondback 360® PAD System, a minimally invasive catheter for treating PAD anywhere in the leg.

19 Nov 2009

Recent progress of Delcath Systems in drug delivery platform reported

Delcath Systems, Inc., a medical technology company developing the Delcath Percutaneous Hepatic Perfusion (PHP(TM)) System, a minimally invasive drug delivery platform for the regional treatment of cancer metastatic to the liver, today reported on the Company's recent progress.

19 Nov 2009

Treatment of iron deficiency can improve symptoms and quality of life in CHF patients

Intravenous (I.V.) iron treatment with ferric carboxymaltose to reverse iron deficiency can significantly improve symptoms, exercise tolerance and quality of life for chronic heart failure (CHF) patients, researchers said in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

19 Nov 2009

Continuous flow heart pump improves survival rates in heart failure patients than current pulsating models

A new, continuous flow heart pump, or left ventricular assist device (LVAD), delivered better two-year survival in advanced heart failure patients than the current pulsatile model, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

19 Nov 2009

PanGenex expands clinical trial sites of its Calci-CLEAR system

PanGenex Corporation announced that due to promising pre-clinical results from its clinical trial at the Cardiovascular Institute of the South (http://www.cardio.com/site1.php), the Company will extend its trial to two additional sites.

19 Nov 2009

AFFiRiS to commence Phase II trial of its Alzheimer's vaccine candidate

AFFiRiS AG will focus its Alzheimer's vaccine program on one product candidate at an unexpectedly early stage of development: the vaccine candidate AD02 is planned to enter into Phase II clinical trial early in 2010. This decision by the company immediately follows the completion of two Phase I trials with the candidates AD01 and AD02. The company based its fast decision on the first interim analysis of the secondary endpoints at the six month time point.

19 Nov 2009

RBM and Covance sign biomarker alliance and services agreement

Rules-Based Medicine, Inc. (RBM) today announced it has entered into a biomarker alliance and services agreement with Covance Inc. that will provide biotechnology and pharmaceutical companies with a powerful combination of biomarker technologies and services for use in drug development. Under terms of the agreement, Covance will use RBM as its exclusive third-party provider of multiplexed protein biomarker testing services, and RBM shall use Covance as its exclusive referral source for laboratory testing services.

19 Nov 2009

BioAlliance Pharma wins first prize in Deloitte's Technology Fast 50 2009

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced that it has won first prize in Deloitte's Technology Fast 50 2009TM ranking of France's fastest-growth technology companies.

19 Nov 2009

New biomarkers can predict patients' response to certain drugs

Recent advances in cancer therapeutics have led to the discovery of biomarkers that can predict patient response to certain drugs. Screening for mutations in the epidermal growth factor receptor (EGRF) prior to non-small cell lung cancer treatment, for example, has been shown to indentify patients who are likely to respond to treatment with erlontinib. This maximizes the drug's impact, and spares patients who are not likely to benefit from being subjected to potentially debilitating side effects.

19 Nov 2009

Ecron Acunova establishes new office in Moscow, Russia

Ecron Acunova, a full-service clinical research organization (CRO), with offices across Europe, in India and the US, has strengthened its Eastern European presence further by opening a new office in Moscow, Russia in October 2009.

19 Nov 2009

Results from Phase IIa clinical trial evaluating VT-111 reported by Viron Therapeutics

Viron Therapeutics Inc., a biotechnology company pioneering the development of immune-modulating protein therapeutics derived from pathogens, today reported results from a Phase IIa clinical trial evaluating VT-111 (Serp-1), an anti-inflammatory protein derived from the myxoma virus.

19 Nov 2009

Endologix receives IDE conditional approval from FDA

Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced today that it has received Investigational Device Exemption (IDE) conditional approval from the United States Food and Drug Administration ("FDA") to begin a prospective, multicenter, randomized clinical trial for a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair (EVAR) utilizing the Company's IntuiTrak(TM) endovascular delivery system for the Powerlink® family of stent grafts.

19 Nov 2009

Covance and Rules-Based Medicine enter into biomarker alliance and services agreement

Covance Inc., a leading provider of drug development services, announced today that it entered into a biomarker alliance and services agreement with Rules-Based Medicine, Inc. (RBM), a leading provider of multiplexed protein biomarker testing to the pharmaceutical industry.

19 Nov 2009

CEL-SCI commences clinical study of LEAPS-H1N1 treatment for hospitalized patients

CEL-SCI Corporation, a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases and a late-stage oncology company, announced today the start of the Company's first clinical study for hospitalized H1N1 patients at The Johns Hopkins University School of Medicine (Johns Hopkins).

18 Nov 2009

Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

Millennium: The Takeda Oncology Company today announced it has further expanded its protein homeostasis program with the initiation of a Phase I clinical trial for an oral formulation of MLN9708, the Company’s second-generation proteasome inhibitor. An intravenous formulation of MLN9708 entered clinical trials in March.

18 Nov 2009

Lee's Pharmaceutical granted exclusive license to Jennerex' lead product for HCC

Jennerex, Inc., a clinical-stage biotherapeutics company developing a proprietary breakthrough class of targeted oncolytic virus therapeutics, today announced in conjunction with Lee's Pharmaceutical Holdings, the execution of a collaboration and license agreement for Jennerex's lead product candidate, JX-594, in certain Asian territories.

18 Nov 2009

CytRx plans Phase 2 clinical trial of its doxorubicin prodrug for advanced gastric cancer

CytRx Corporation, a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.

18 Nov 2009

Clinical Trial News and Research

MONITORING FORCE files for Flibanserin orphan drug status designation with the EMEA

Advanced Cell Technology files an IND with the FDA for study using embryonic stem cells to treat SMD

Aegera Therapeutics commences AEG35156 Phase 2B study for AML

Cardiovascular Systems commences patient enrollment in CALCIUM 360° clinical trial

Recent progress of Delcath Systems in drug delivery platform reported

Treatment of iron deficiency can improve symptoms and quality of life in CHF patients

Continuous flow heart pump improves survival rates in heart failure patients than current pulsating models

PanGenex expands clinical trial sites of its Calci-CLEAR system

AFFiRiS to commence Phase II trial of its Alzheimer's vaccine candidate

RBM and Covance sign biomarker alliance and services agreement

BioAlliance Pharma wins first prize in Deloitte's Technology Fast 50 2009

New biomarkers can predict patients' response to certain drugs

Ecron Acunova establishes new office in Moscow, Russia

Results from Phase IIa clinical trial evaluating VT-111 reported by Viron Therapeutics

Endologix receives IDE conditional approval from FDA

Covance and Rules-Based Medicine enter into biomarker alliance and services agreement

CEL-SCI commences clinical study of LEAPS-H1N1 treatment for hospitalized patients

Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

Lee's Pharmaceutical granted exclusive license to Jennerex' lead product for HCC

CytRx plans Phase 2 clinical trial of its doxorubicin prodrug for advanced gastric cancer

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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