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Positive results from Isis Pharmaceuticals' ISIS 113715 Phase 2 study in type 2 diabetes patients

Isis Pharmaceuticals, Inc. today announced positive top-line results from a Phase 2 study evaluating the safety and efficacy of ISIS 113715 in patients with type 2 diabetes. ISIS 113715 is a novel insulin sensitizer that reduces the expression of protein tyrosine phosphatase-1B (PTP-1B). The study showed consistent and statistically significant reductions in multiple short and intermediate measures of glucose control.

22 Oct 2009

Positive results from Argos Therapeutics' personalized immunotherapy candidate AGS-004 Phase 2a trial

Argos Therapeutics today announced two presentations at the AIDS Vaccine 2009 conference, detailing positive viral load, immune response and safety data from an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate. AGS-004 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden.

21 Oct 2009

Northwest Biotherapeutics announces long-term data from Phase I and Phase I/II clinical trials of DCVax-Brain

Northwest Biotherapeutics, Inc. today announced further long-term follow-up data, for the period from January through September 2009, from its prior Phase I and Phase I/II clinical trials conducted at UCLA with DCVax®-Brain in patients with Glioblastoma multiforme ("GBM"). GBM is the most rapid and lethal type of brain cancer. During the update period, only one of the twenty patients treated with DCVax®-Brain (in addition to standard of care) died, and that patient had survived for nearly 7 years (80.5 months).

21 Oct 2009

CombinatoRx announces Synavive Phase 2 extension trial results at the 2009 ACR meeting

CombinatoRx, Incorporated today announced the results of a 12 month knee osteoarthritis (OA) Phase 2 extension trial for Synavive™ (CRx-102) at the American College of Rheumatology (ACR) 2009 Annual Meeting in Philadelphia. The data demonstrated that Synavive-treated subjects maintained efficacy levels throughout the 12 month extension trial.

21 Oct 2009

Celsion completes patient enrollment in its global Phase III ThermoDox trial

Celsion Corporation announced today that it has completed a critical regulatory step in the countries of China and Japan to rapidly enroll patients in its global Phase III ThermoDox trial for the treatment of Hepatocellular Carcinoma (HCC), also known as primary liver cancer.

21 Oct 2009

Delcath Systems completes its pivotal Phase III Metastatic Melanoma Trial enrollment

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that its pivotal Phase III Metastatic Melanoma Trial has met its goal of 92 patients and is fully enrolled.

21 Oct 2009

New results from ADVANCE provide important insights to reduce diabetes complications

New results from ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation), the largest clinical trial ever performed in patients with type 2 diabetes worldwide, provide important insights into the therapeutic strategy to adopt for efficient and safe blood glucose control aimed at the reduction of severe diabetes complications.

21 Oct 2009

Clinical data supports continued development of ORENCIA administration for rheumatoid arthritis

Bristol-Myers Squibb Company announced today that new clinical data support continued development of a subcutaneous administration of ORENCIA® (abatacept) for patients with moderate to severe rheumatoid arthritis.

21 Oct 2009

Genzyme commences patient enrollment in Genz-112638 phase 3 trials

Genzyme Corporation today announced that the company has begun enrollment in the first of two global, multi-center, phase 3 trials of Genz-112638, a potential new oral therapy for Gaucher disease type 1. The two multi-national, multi-center trials are being conducted to evaluate the safety and efficacy of the small molecule.

21 Oct 2009

MediWound reports positive results from phase III Debrase trial for treating burns

Teva Pharmaceutical Industries Ltd. announced today that MediWound Ltd., a company in which Teva holds an 11% interest, reported positive results from a pre planned interim analysis of a phase III trial for Debrase®, an enzymatic debriding agent for burns.

21 Oct 2009

AFFiRiS reports encouraging results from clinical studies of its two Alzheimer's vaccines

AFFiRiS AG today announced that the primary endpoints have been met for the Phase I clinical studies of its two Alzheimer's vaccines AD01 and AD02, which demonstrated favourable safety and tolerability profiles. These results trigger a 10 million EUR milestone payment from licensee GlaxoSmithKline Biologicals.

21 Oct 2009

Positive results from KAI Pharmaceuticals' pain therapeutic program

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, announced positive preclinical results from its program targeting the gamma protein kinase C (PKC) pathway for the development of novel therapies for pain.

20 Oct 2009

Tarsa Therapeutics receives license for Phase III oral calcitonin program

Unigene Laboratories, Inc. and Tarsa Therapeutics, Inc. today announced that Unigene has licensed its Phase III oral calcitonin program to Tarsa, a new company formed by a syndicate of three venture capital funds specializing in the life sciences: MVM Life Science Partners, Quaker BioVentures and Novo A/S.

20 Oct 2009

Positive data from BioSante Pharmaceuticals' LibiGel Phase III clinical development program

BioSante Pharmaceuticals, Inc., today announced positive safety data in its ongoing LibiGel Phase III clinical development program. For the first time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review of unblinded data, the DMC unanimously recommended continuation of the study as described in the study protocol, with no modifications.

20 Oct 2009

Targacept presents data from Phase 2b clinical trial of TC-5214

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics-, today announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide.

20 Oct 2009

Novartis' Tasigna capsules meets primary endpoint in comparison trial with Gleevec

Novartis announced today that Tasigna (nilotinib) 200 mg capsules met its primary endpoint in the first head-to-head comparison with the company's groundbreaking drug Gleevec (imatinib mesylate) tablets*. Tasigna produced faster and deeper responses than Gleevec when given as first-line therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna was well tolerated in the study.

20 Oct 2009

Bristol-Myers Squibb presents study data on ORENCIA for treating rheumatoid arthritis

Bristol-Myers Squibb Company today announced two-year results of a study that supports use of ORENCIA® (abatacept) for methotrexate-naive patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

20 Oct 2009

Repligen completes patient treatment in its Phase 3 RG1068 clinical trial

Repligen Corporation reported today that it has completed patient treatment in its Phase 3 clinical trial of RG1068, synthetic human secretin, in magnetic resonance imaging (MRI) of the pancreas. The study is designed to assess the sensitivity and specificity of RG1068 in conjunction with MRI for the detection of pancreatic duct abnormalities compared to MRI alone.

20 Oct 2009

SIMPONI treatment results in greater inhibition of structural damage in arthritis patients

Phase 3 data reported for the first time show that once every four week subcutaneous injections of SIMPONI(TM) (golimumab) resulted in significantly greater inhibition of structural damage compared with placebo plus methotrexate in patients with active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA).

20 Oct 2009

Elan and Biogen Idec to present TYSABRI study data at ACG meeting

Elan Corporation, plc and Biogen Idec today announced multiple presentations at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 23-28 in San Diego.

20 Oct 2009

Drug Trial News

Positive results from Isis Pharmaceuticals' ISIS 113715 Phase 2 study in type 2 diabetes patients

Positive results from Argos Therapeutics' personalized immunotherapy candidate AGS-004 Phase 2a trial

Northwest Biotherapeutics announces long-term data from Phase I and Phase I/II clinical trials of DCVax-Brain

CombinatoRx announces Synavive Phase 2 extension trial results at the 2009 ACR meeting

Celsion completes patient enrollment in its global Phase III ThermoDox trial

Delcath Systems completes its pivotal Phase III Metastatic Melanoma Trial enrollment

New results from ADVANCE provide important insights to reduce diabetes complications

Clinical data supports continued development of ORENCIA administration for rheumatoid arthritis

Genzyme commences patient enrollment in Genz-112638 phase 3 trials

MediWound reports positive results from phase III Debrase trial for treating burns

AFFiRiS reports encouraging results from clinical studies of its two Alzheimer's vaccines

Positive results from KAI Pharmaceuticals' pain therapeutic program

Tarsa Therapeutics receives license for Phase III oral calcitonin program

Positive data from BioSante Pharmaceuticals' LibiGel Phase III clinical development program

Targacept presents data from Phase 2b clinical trial of TC-5214

Novartis' Tasigna capsules meets primary endpoint in comparison trial with Gleevec

Bristol-Myers Squibb presents study data on ORENCIA for treating rheumatoid arthritis

Repligen completes patient treatment in its Phase 3 RG1068 clinical trial

SIMPONI treatment results in greater inhibition of structural damage in arthritis patients

Elan and Biogen Idec to present TYSABRI study data at ACG meeting

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