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Washington Post examines development of vaccine for food borne intestinal illness

The Partnership for Public Service/Washington Post examines how decades of work by Navy scientist Patricia Guerry could lead to "the first vaccine for a food borne intestinal illness that affects hundreds of millions of people worldwide each year."

26 Aug 2009

Alvine Pharmaceuticals commences Phase 2a clinical trial to evaluate the efficacy of ALV003

Alvine Pharmaceuticals, Inc. today announced that patient enrollment has begun in a Phase 2a, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ALV003 for use in the treatment of celiac disease.

26 Aug 2009

Venlafaxine alleviates depressive symptoms

The Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether patients with depression benefit from taking drugs belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) drug class.

25 Aug 2009

Delcath Systems enrolls 85 patients for its pivotal Phase III Metastatic Melanoma Trial

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that it has exceeded 90% enrollment reaching 85 patients for its pivotal Phase III Metastatic Melanoma Trial.

25 Aug 2009

Subject enrollment in patients with retinitis pigmentosa for Phase 2 clinical study completed by R-Tech Ueno

We are pleased to announce that subject enrollment for the phase 2 clinical study of 0.15% UF-021 (generic name; isopropyl unoprostone; active ingredient of Rescula(R) eye-drops) in patients with retinitis pigmentosa has been completed.

25 Aug 2009

Seattle Genetics completes enrollment of its pivotal clinical trial of brentuximab vedotin

Seattle Genetics, Inc. today announced that it has completed enrollment of its pivotal clinical trial of brentuximab vedotin (SGN-35) for relapsed and refractory Hodgkin lymphoma. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30 utilizing the company’s proprietary ADC technology.

25 Aug 2009

Regado Biosciences to commence Phase I study of a subcutaneous administration formulation of the REG1 anticoagulation system

Regado Biosciences, Inc, a privately held company leading the development of antithrombotic therapeutic aptamers with active control agents, today announced enrollment of the first patient in the first Phase I study of a subcutaneous administration formulation of the REG1 anticoagulation system.

25 Aug 2009

Phase I/II trial of Amphinex uses photochemical internalisation approach

PCI Biotech Holding ASA, the Norwegian drug delivery company focusing on effective delivery of cancer therapeutics, today announced that the first patient has received treatment in the Phase I/II trial with the lead candidate Amphinex(R), which uses a new approach called photochemical internalisation.

25 Aug 2009

Orphan drug status granted to BioCancell's BC-819 drug

Tikcro Technologies today announced that the United States (“US”) Department of Health and Human Services ("HHS") has granted orphan drug status to BioCancell's BC-819 drug, currently in Phase I/IIa clinical trials, for its use in treating ovarian cancer.

24 Aug 2009

Retigabine's Phase IIa clinical trial preliminary results announced

Valeant Pharmaceuticals International today announced preliminary results from its Phase IIa proof-of-concept clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia (PHN), a painful and common complication of shingles.

24 Aug 2009

Israeli government and a private investment fund Brainstorm Cell Therapeutics to complete pre-clinical studies in ALS

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that the company has secured the funding required to complete pre-clinical trials underway for the treatment of ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s disease). The company expects to begin Phase I clinical studies in 2010.

24 Aug 2009

CSL Biotherapies initiates clinical trials of Influenza A/H1N1 2009 vaccine in the US

CSL Biotherapies has announced the initiation of the company’s first U.S. clinical trials of its candidate Influenza A/H1N1 2009 vaccine. Study investigators will administer vaccinations to the first U.S. study volunteers today, August 24. The studies will determine the safety of CSL’s candidate vaccine and its ability to elicit an immune response (also referred to as immunogenicity) in adults and children.

24 Aug 2009

Profibrix raises funds for clinical and preclinical development

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the successful closing of a US $11 million series B investment. The financing round was led by new investor Gilde Healthcare Partners, a leading European life sciences investor, who joins existing investor Index Ventures. Dirk Kersten from Gilde will join the company's Supervisory Board.

24 Aug 2009

Biovail enters into an agreement with Santhera to develop and market JP-1730/fipamezole drug

Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into an agreement with Santhera Pharmaceuticals (Switzerland) Ltd., a subsidiary of Santhera Pharmaceuticals Holding AG (SIX: SANN) to acquire the U.S. and Canadian rights to develop and commercialize Santhera’s JP-1730/fipamezole for the treatment of Dyskinesia in Parkinson’s Disease (DPD). JP-1730/ fipamezole is a first-in-class compound that, in a recent Phase IIb study, displayed the potential to reduce levodopa-induced dyskinesia.

24 Aug 2009

Adamas Pharmaceuticals forges agreement with U.S. Naval Health Research Center for evaluating triple combination antiviral drug

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Naval Health Research Center for preclinical studies evaluating Adamas' triple combination antiviral drug (TCAD) therapy for influenza A, including novel influenza A/H1N1. TCAD therapy includes Adamas' investigational proprietary fixed-dose oral combination drug, to be administered adjunctively with a neuraminidase inhibitor, including Tamiflu (oseltamivir phosphate, Roche).

22 Aug 2009

Endologix publishes abdominal aortic aneurysm treatment trial results online

Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced today the online publication of results from the pivotal prospective, multicenter clinical trial of the Company's Powerlink XL((R)) System for treatment of abdominal aortic aneurysm in large diameter proximal aortic necks.

21 Aug 2009

NY-ESO-1 recombinant proteins to be used in clinical trials for treating melanoma and ovarian cancer

The Bioproduction Facility at Cornell University has produced the first batch of NY-ESO-1 recombinant protein-a cancer vaccine-that will be used in clinical trials for patients facing either ovarian cancer or melanoma. The facility was developed as a partnership between The Ludwig Institute for Cancer Research and Cornell University.

21 Aug 2009

Peplin completes four-week enrolment phase for REGION-Ib trial

Peplin, Inc. (ASX:PLI) today announced completion of enrolment in its second Phase 3 clinical trial for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on non-head treatment areas, which include the trunk and extremities. This completes enrolment in the final of four pivotal trials planned for the submission of the New Drug Application (NDA) for AK.

20 Aug 2009

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Roche (SIX: ROG.VX; RO.S, OTCQX: RHHBY) and InterMune, Inc. (Nasdaq: ITMN) today announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin). The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 - the most difficult to treat form of the virus - will participate.

20 Aug 2009

Light Sciences Oncology announces Phase 2 trial of Aptocine in Benign Prostatic Hyperplasia

Light Sciences Oncology, Inc. (LSO) today announced the treatment of the first patients in a Phase 2 clinical trial of its innovative targeted drug treatment Aptocine(TM) (talaporfin sodium) in Benign Prostatic Hyperplasia (BPH). The Phase 2 trial expands the Aptocine BPH development program on the basis of a Phase 1 study at escalating light doses. In the open-label Phase 2 trial, Aptocine is being tested for safety and efficacy in 40 patients with lower urinary tract symptoms (LUTS) due to BPH. Aptocine is also in two Phase 3 clinical trials for solid tumors in the liver as well as preclinical development for prostate cancer.

19 Aug 2009

Drug Trial News

Washington Post examines development of vaccine for food borne intestinal illness

Alvine Pharmaceuticals commences Phase 2a clinical trial to evaluate the efficacy of ALV003

Venlafaxine alleviates depressive symptoms

Delcath Systems enrolls 85 patients for its pivotal Phase III Metastatic Melanoma Trial

Subject enrollment in patients with retinitis pigmentosa for Phase 2 clinical study completed by R-Tech Ueno

Seattle Genetics completes enrollment of its pivotal clinical trial of brentuximab vedotin

Regado Biosciences to commence Phase I study of a subcutaneous administration formulation of the REG1 anticoagulation system

Phase I/II trial of Amphinex uses photochemical internalisation approach

Orphan drug status granted to BioCancell's BC-819 drug

Retigabine's Phase IIa clinical trial preliminary results announced

Israeli government and a private investment fund Brainstorm Cell Therapeutics to complete pre-clinical studies in ALS

CSL Biotherapies initiates clinical trials of Influenza A/H1N1 2009 vaccine in the US

Profibrix raises funds for clinical and preclinical development

Biovail enters into an agreement with Santhera to develop and market JP-1730/fipamezole drug

Adamas Pharmaceuticals forges agreement with U.S. Naval Health Research Center for evaluating triple combination antiviral drug

Endologix publishes abdominal aortic aneurysm treatment trial results online

NY-ESO-1 recombinant proteins to be used in clinical trials for treating melanoma and ovarian cancer

Peplin completes four-week enrolment phase for REGION-Ib trial

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Light Sciences Oncology announces Phase 2 trial of Aptocine in Benign Prostatic Hyperplasia

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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