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RTOG reports on largest trial for newly diagnosed glioblastoma

RTOG reports on the largest trial to-date for patients with newly diagnosed glioblastoma demonstrating the importance and feasibility of prospective molecular analysis of tumor tissue although finding that patients received no additional benefit from dose-intensive temozolomide as compared to standard adjuvant temozolomide after combined temozolomide and radiotherapy.

20 May 2011

AMT presents long-term efficacy study of Glybera in treatment of lipoprotein lipase deficiency

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today results from a long-term efficacy study of Glybera (alipogene tiparvovec) that showed improved chylomicron metabolism could be used as a biomarker for increased lipoprotein lipase (LPL) activity in those patients missing the gene that produces this protein.

20 May 2011

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. today announced results from a Phase 2b trial evaluating Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic breast cancer previously treated with a bevacizumab-containing regimen, which showed that Nexavar was associated with statistically significant improvements in progression-free survival and time-to-progression.

20 May 2011

VBL to present positive VB-111 preclinical data in metastatic lung cancer at 14th ASGCT

VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced that it will present preclinical data demonstrating VB-111's potential synergy and additive therapeutic effect when administered in combination with the conventional chemotherapy cancer treatments.

20 May 2011

Lilly's cixutumumab Phase II study results in five subtypes of sarcoma to be presented at 47th ASCO

Eli Lilly and Company announced data from its Phase II study with cixutumumab in five subtypes of sarcoma, a cancer that develops from connective tissues in the body.

20 May 2011

$Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma$

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. today announced updated results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. Carfilzomib achieved a clinical benefit rate (CBR) (minimal response or greater) in the study population of 37 percent with a duration of response (DOR) of 8.3 months.

20 May 2011

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

ViroPharma Incorporated today announced initiation of a Phase 2 dose-ranging clinical study to evaluate the safety, tolerability, and efficacy of VP 20621 for prevention of recurrence of Clostridium difficile infection (CDI) in adults previously treated for CDI.

20 May 2011

CEL-SCI initiates global Multikine Phase III trial for head and neck cancer in Russia

CEL-SCI Corporation announced today that it has commenced its global Phase III clinical trial for Multikine®, the Company's flagship immunotherapy, in Russia at the State Budgetary Healthcare Institution of Sverdlovsk Region - Sverdlovsk Regional Oncology Center in Ekaterinburg, Russia.

20 May 2011

Enzon to discontinue PEG-SN38 clinical program in metastatic colorectal cancer

Enzon Pharmaceuticals, Inc. today announced that, in light of evolving standards of care for the treatment of metastatic colorectal cancer (mCRC), the Company will discontinue its PEG-SN38 (EZN-2208) clinical program in this disease, following conclusion of its Phase II study.

19 May 2011

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Advantagene, Inc., a Massachusetts-based biopharmaceutical company, announced today that it reached an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of ProstAtak™, its lead agent for patients with newly diagnosed prostate cancer.

19 May 2011

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced that it has initiated a Phase 2 clinical trial of arhalofenate (MBX-102), its product candidate for the management of hyperuricemia in patients with gout.

19 May 2011

PolyMedix's PMX-30063 compound mitigates ulcerative mucositis in pre-clinical studies

PolyMedix, Inc., a biotechnology company focused on developing new therapeutic drugs to treat patients with acute infectious diseases and cardiovascular disorders, announced today that its lead defensin-mimetic antibiotic compound, PMX-30063, when administered topically as an oral rinse, has shown activity against oral mucositis in an animal study.

19 May 2011

RXi to present updated NeuVax Phase II trial data in breast cancer at ASCO 2011

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted and immunotherapy technologies, will be presenting data from the NeuVax Phase II adjuvant breast cancer clinical trial at the 2011 annual meeting of The American Society of Clinical Oncology in Chicago.

19 May 2011

Repligen receives approval from FDA to commence RG3039 Phase 1 trial in Spinal Muscular Atrophy

Repligen Corporation announced today that it has received approval from the Food and Drug Administration to initiate a Phase 1 clinical trial of RG3039, a potential treatment for Spinal Muscular Atrophy.

19 May 2011

Isis receives $5M milestone payment from GSK for initiating ISIS-TTRRx Phase 1 study

Isis Pharmaceuticals, Inc. announced today that it has earned a $5 million milestone payment from GlaxoSmithKline related to the initiation of a Phase 1 clinical study for ISIS-TTRRx.

19 May 2011

Omeros advances OMS103HP and OMS302 into Phase 3 clinical programs

Omeros Corporation today announced that it is advancing two of its product candidates from its PharmacoSurgery platform – OMS103HP for arthroscopic meniscectomy and OMS302 for intra-ocular lens replacement surgery – into Phase 3 clinical development programs.

19 May 2011

AstraZeneca announces encouraging results from olaparib phase II study in serous ovarian cancer

AstraZeneca announced today encouraging results from a phase II study in patients with platinum-sensitive relapsed serous ovarian cancer (SOC) who had received maintenance treatment with the investigational drug olaparib, after the completion of chemotherapy.

19 May 2011

TissueGene commences enrollment in TG-C Phase II trial for severe knee osteoarthritis

TissueGene, Inc. announced today that it has initiated patient enrollment for a U.S. Phase II clinical trial of its lead product candidate TG-C. TG-C involves human allogeneic chondrocytes developed to produce the therapeutic protein TGF-beta1 for the regeneration of cartilage in patients suffering from severe osteoarthritis of the knee.

19 May 2011

YM BioSciences announces updated interim results from CYT387 Phase I/II trial in myelofibrosis

YM BioSciences Inc., today reported updated interim results for the first 60 patients with high/intermediate-risk myelofibrosis who have completed a minimum of three cycles of treatment (12 weeks) in its ongoing Phase I/II multi-center study.

19 May 2011

Silence to present new Atu027 Phase I study data in advanced solid tumors at ASCO annual meeting

Silence Therapeutics plc, a leading global RNA interference therapeutics company, announces that it will present new data from its ongoing Phase I study of Atu027, its lead internal therapeutic candidate, at the 2011 American Society of Clinical Oncology Annual Meeting on 06 June 2011.

19 May 2011

Drug Trial News

RTOG reports on largest trial for newly diagnosed glioblastoma

AMT presents long-term efficacy study of Glybera in treatment of lipoprotein lipase deficiency

Bayer, Onyx to present Nexavar-chemotherapy combination Phase 2b trial data in breast cancer at ASCO 2011

VBL to present positive VB-111 preclinical data in metastatic lung cancer at 14th ASGCT

Lilly's cixutumumab Phase II study results in five subtypes of sarcoma to be presented at 47th ASCO

Positive results from Onyx's carfilzomib Phase 2b 003-A1 study in relapsed and refractory multiple myeloma

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

CEL-SCI initiates global Multikine Phase III trial for head and neck cancer in Russia

Enzon to discontinue PEG-SN38 clinical program in metastatic colorectal cancer

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Metabolex commences arhalofenate Phase 2 clinical trial for treatment of hyperuricemia and gout

PolyMedix's PMX-30063 compound mitigates ulcerative mucositis in pre-clinical studies

RXi to present updated NeuVax Phase II trial data in breast cancer at ASCO 2011

Repligen receives approval from FDA to commence RG3039 Phase 1 trial in Spinal Muscular Atrophy

Isis receives $5M milestone payment from GSK for initiating ISIS-TTRRx Phase 1 study

Omeros advances OMS103HP and OMS302 into Phase 3 clinical programs

AstraZeneca announces encouraging results from olaparib phase II study in serous ovarian cancer

TissueGene commences enrollment in TG-C Phase II trial for severe knee osteoarthritis

YM BioSciences announces updated interim results from CYT387 Phase I/II trial in myelofibrosis

Silence to present new Atu027 Phase I study data in advanced solid tumors at ASCO annual meeting

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