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NCI awards Altor Bioscience a $3 MM grant to develop its targeted cancer therapeutic ALT-801

Altor BioScience Corporation announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase II Bridge Grant by the National Cancer Institute (NCI). The award of $3 MM over three years will help Altor further its clinical development of ALT-801, a novel tumor-targeted immunotherapeutic designed to improve the efficacy and safety of the FDA-approved anticancer cytokine, interleukin-2 (IL-2).

25 Sep 2009

US Treasury Department clears YM BioSciences' nimotuzumab clinical program extension

YM BioSciences Inc. a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported operational and financial results for its fiscal year end, ended June 30, 2009.

25 Sep 2009

Phase III PLATO study proves that ticagrelor is more effective than clopidogrel

New data from the phase III PLATO study showed that ticagrelor (BRILINTA((TM))) provided greater reduction of cardiovascular (CV) events (composite of CV death, heart attack and stroke) than clopidogrel (9.02% vs. 10.65%,>

25 Sep 2009

Results from COGENT clinical trial presented at TCT symposium

Results from a late breaking clinical trial called COGENT demonstrate that the combination of giving patients clopidogrel, a blood thinner commonly prescribed to patients with cardiovascular disease, and stomach medicines such as omeprazole, known as proton pump inhibitors (PPIs), did not lead to adverse events, as some prior studies had suggested.

25 Sep 2009

Huachansu may slow cancer progression

Huachansu, a Chinese medicine that comes from the dried venom secreted by the skin glands of toads, has tolerable toxicity levels, even at doses eight times those normally administered, and may slow disease progression in some cancer patients, say researchers from The University of Texas M. D. Anderson Cancer Center.

25 Sep 2009

Partial success reported in the Phase 3 trial of HIV/AIDS vaccine

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), was pleased to hear the announcement today of partial success in the recently completed Phase 3 trial in Thailand of a candidate HIV/AIDS vaccine owned by Sanofi-Aventis and Global Solutions for Infectious Diseases.

25 Sep 2009

CTRC commences patient enrolment in Phase 2 clinical trial of REOLYSIN for metastatic melanoma

Oncolytics Biotech Inc. announced today that the Cancer Therapy Research Center at the University of Texas Health Science Center (CTRC) has started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with metastatic melanoma.

24 Sep 2009

Karo Bio announces clinical phase II results of thyroid hormone analog eprotirome

The Swedish biotech company Karo Bio today announced that results from a clinical phase II study of the company’s thyroid hormone analog eprotirome, and its additive effects on dyslipidemia in ezetimibe-treated patients, are subject to a scientific presentation.

24 Sep 2009

Phase II study of OPAXIO to be revealed

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that data from a Phase II study from Brown University of OPAXIO(TM) (paclitaxel poliglumex) combined with standard cisplatin and concurrent radiation in patients with advanced esophageal cancer will be presented by Dr. Howard Safran in an oral Proffered Papers session at the Annual Meeting of the International Society of Gastrointestinal Oncology in Philadelphia, Pennsylvania on Thursday, October 1st at 2:35 p.m. (Eastern time).

24 Sep 2009

Phase III efficacy trial of two AIDS vaccine candidates shows promise

The International AIDS Vaccine Initiative (IAVI) greeted with excitement today’s announcement by the U.S. Military HIV Research Program and the Thai Ministry of Public Health that, according to an initial analysis, a prime-boost combination of two AIDS vaccine candidates has shown partial efficacy in a phase III efficacy trial in Thailand. The prime-boost combination appeared to be about 31% effective at preventing infection with HIV.

24 Sep 2009

ThromboGenics completes enrollment for MIVI-TRUST clinical trial

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that it has completed the enrolment of the US Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease.

24 Sep 2009

CEL-SCI Corporation engages a CRO for clinical trial of its investigational LEAPS-H1N1 treatment

CEL-SCI Corporation (NYSE AMEX: CVM), a developer of vaccines and therapeutics for the treatment of infectious diseases and a late-stage oncology company, announced today that it has hired a full-service Clinical Research Organization (CRO) with an office in the Washington, D.C./Baltimore area to support its conduct of the upcoming clinical trial of its investigational LEAPS-H1N1 treatment.

24 Sep 2009

MicroDose initiates Phase 1 clinical trial investigating the pharmacokinetics of atropine inhalation

MicroDose Therapeutx Inc. (formerly MicroDose Technologies) today announced that it has initiated a Phase I study at the University of Pittsburgh Medical Center with atropine sulfate delivered from the MicroDose proprietary dry powder inhaler (DPI). The study is a further step in the development program for an atropine inhaler to treat nerve agent poisoning in military and civil defense applications.

24 Sep 2009

Enrollment for pSivida's pilot FAVOR clinical study commences

pSivida Corp., a leading drug delivery company that has developed two of the only three products approved by the FDA for the long term, sustained release delivery of drug to treat chronic back of the eye disease, today announced that enrollment has begun for a pilot study to assess the safety and efficacy of Iluvien in patients with macular edema secondary to retinal vein occlusion.

24 Sep 2009

FDA endorses Covidien's REMS program for EXALGO tablets

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New Drug Application and proposed Risk Evaluation and Mitigation Strategy (REMS) program for EXALGOTM (hydromorphone HCl extended release) tablets, an opioid formulation.

24 Sep 2009

Results of Phase III clinical trial of HIV vaccine released

A Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection. According to final results released by the trial sponsor, the U.S. Army Surgeon General, the prime boost combination of ALVAC(R)( )HIV and AIDSVAX(R) B/E( )lowered the rate of HIV infection by 31.2% compared with placebo.

24 Sep 2009

Medivation commences patient treatment in clinical trial of MDV3100 in advanced prostate cancer

Medivation, Inc. (Nasdaq: MDVN) today announced treatment of the first patient in a Phase 3 clinical trial of the investigational drug MDV3100 in advanced prostate cancer. Known as AFFIRM, the trial will evaluate the novel androgen receptor antagonist MDV3100 in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.

24 Sep 2009

Lux Biosciences announces results of its LX214 human safety study for dry eye syndrome

Lux Biosciences, Inc. a privately held biotechnology company focused on the treatment of ophthalmic diseases, today announced results from a Phase 1 human safety and an open-label pilot efficacy study of the company’s potential best-in-class therapy for dry eye, LX214 (topical mixed nanomicellar formulation of voclosporin).

24 Sep 2009

Oxygen Biotherapeutics to commence Phase II-b trial of Oxycyte in treating traumatic brain injury

Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has received approval from Israel's Ministry of Health to begin a Phase II-b, dose escalation, clinical trial in that country for use of Oxycyte(R) in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.

23 Sep 2009

Results of Phase 3 CRYSTAL study of mCRC patients announced

The retrospective CRYSTAL analysis was conducted as a result of an effort to increase the tissue ascertainment rate to determine the K-ras status of patients’ tumors. The analysis included extended patient follow up of nearly 1.5 years and doubled the tissue ascertainment rate from 45% to 89%. These data are an update from the overall survival results from CRYSTAL that were published in the April 2009 issue of the New England Journal of Medicine.

23 Sep 2009

Drug Trial News

NCI awards Altor Bioscience a $3 MM grant to develop its targeted cancer therapeutic ALT-801

US Treasury Department clears YM BioSciences' nimotuzumab clinical program extension

Phase III PLATO study proves that ticagrelor is more effective than clopidogrel

Results from COGENT clinical trial presented at TCT symposium

Huachansu may slow cancer progression

Partial success reported in the Phase 3 trial of HIV/AIDS vaccine

CTRC commences patient enrolment in Phase 2 clinical trial of REOLYSIN for metastatic melanoma

Karo Bio announces clinical phase II results of thyroid hormone analog eprotirome

Phase II study of OPAXIO to be revealed

Phase III efficacy trial of two AIDS vaccine candidates shows promise

ThromboGenics completes enrollment for MIVI-TRUST clinical trial

CEL-SCI Corporation engages a CRO for clinical trial of its investigational LEAPS-H1N1 treatment

MicroDose initiates Phase 1 clinical trial investigating the pharmacokinetics of atropine inhalation

Enrollment for pSivida's pilot FAVOR clinical study commences

FDA endorses Covidien's REMS program for EXALGO tablets

Results of Phase III clinical trial of HIV vaccine released

Medivation commences patient treatment in clinical trial of MDV3100 in advanced prostate cancer

Lux Biosciences announces results of its LX214 human safety study for dry eye syndrome

Oxygen Biotherapeutics to commence Phase II-b trial of Oxycyte in treating traumatic brain injury

Results of Phase 3 CRYSTAL study of mCRC patients announced

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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