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CytRx reaches agreement with FDA for aldoxorubicin Phase 3 trial for treatment of soft tissue sarcomas

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, announced today that it has reached an agreement with the U.S. Food and Drug Administration under a special protocol assessment for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy.

24 Apr 2013

Investigational treatment for ALS passes early phase clinical trial for safety

An investigational treatment for an inherited form of Lou Gehrig's disease has passed an early phase clinical trial for safety, researchers at Washington University School of Medicine in St. Louis and Massachusetts General Hospital report.

24 Apr 2013

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of the latest interim data from a Phase II, multi-center, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172, for the treatment of chronic hepatitis C virus genotype 1 infection.

24 Apr 2013

Janssen announces safety results from two Phase 3 studies of simeprevir in hepatitis C patients

Janssen R&D Ireland today announced primary efficacy and safety results from two global Phase 3 studies demonstrating that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 80 and 81 percent, respectively, of treatment-naive genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis, when administered once daily with pegylated interferon and ribavirin.

24 Apr 2013

Isis Pharmaceuticals starts ISIS-SMNRx Phase 2 study in infants with SMA

Isis Pharmaceuticals, Inc. announced the initiation of a Phase 2 study of ISIS-SMNRx in infants with spinal muscular atrophy. SMA is a severe and rare genetic neuromuscular disease characterized by muscle atrophy and weakness and is the most common genetic cause of infant mortality.

24 Apr 2013

New data on Enanta's lead HCV protease inhibitor to be presented at International Liver Congress

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, announced today that new Phase 2b data related to ABT-450, Enanta's lead HCV protease inhibitor identified in its ongoing collaboration with AbbVie, as well as new preclinical data on Enanta's proprietary cyclophilin inhibitor, EDP-546, will be presented at the International Liver Congress, which is the 48th Annual Meeting of the European Association for the Study of the Liver taking place in Amsterdam April 24-28, 2013.

23 Apr 2013

Phase 1 clinical study of rHIgM22 initiated for treatment of multiple sclerosis

Mayo Clinic and Acorda Therapeutics, Inc. today announced that the first patient has been enrolled in the first clinical trial of rHIgM22, a remyelinating antibody being studied for the treatment of multiple sclerosis.

23 Apr 2013

Clinical data on simeprevir for treatment of hepatitis C patients to be presented at EASL meeting

Medivir AB today announces that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for the treatment of genotype 1 hepatitis C patients.

23 Apr 2013

Gilead Sciences to present results from four Phase 3 clinical trials at International Liver Congress 2013

Gilead Sciences, Inc. today announced that detailed results from four Phase 3 clinical trials (NEUTRINO, FISSION, POSITRON and FUSION) evaluating sofosbuvir, the company's investigational once-daily nucleotide NS5B inhibitor for the treatment of chronic hepatitis C virus infection, will be presented this week in oral sessions at the 48th Annual Meeting of the European Association for the Study of the Liver in Amsterdam, The Netherlands.

23 Apr 2013

ViroPharma announces results of VP20621 Phase 2 study for preventing recurrent CDI

ViroPharma Incorporated, an international biopharmaceutical company committed to developing and commercializing innovative products that address unmet medical needs and rare diseases, today announced the results of a Phase 2 study of VP20621 (non-toxigenic Clostridium difficile; NTCD) a novel treatment approach for preventing recurrent C. difficile infections.

23 Apr 2013

Senesco completes cohort 2 in Phase 1b/2a clinical study of SNS01-T

Senesco Technologies, Inc. reported today that it has completed cohort 2 in its Phase 1b/2a clinical study of SNS01-T.

23 Apr 2013

Merck, Bristol-Myers Squibb to evaluate daclatasvir and MK-5172 for treatment of HCV infection

Merck today announced it has entered into a non-exclusive agreement with Bristol-Myers Squibb to conduct a Phase II clinical trial to evaluate the safety and efficacy of a once-daily oral combination regimen consisting of Bristol-Myers Squibb's investigational NS5A replication complex inhibitor daclatasvir and Merck's investigational NS3/4A protease inhibitor MK-5172 for the treatment of chronic hepatitis C virus infection, genotype 1.

23 Apr 2013

BioInvent starts BI-505 phase II study in patients with smoldering multiple myeloma

BioInvent International announced today that the first patient has been treated in a phase II study of the drug candidate BI-505, developed for the treatment of multiple myeloma.

23 Apr 2013

ARCA biopharma, Medtronic to study effectiveness of Gencaro for prevention of atrial fibrillation

ARCA biopharma, Inc., a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it has entered into an agreement with Medtronic, Inc., a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, to collaborate on ARCA's proposed clinical trial, known as GENETIC-AF, of its lead developmental drug Gencaro (bucindolol hydrochloride).

From Medtronic 23 Apr 2013

Cystic Fibrosis Foundation issues statement on Phase 2 clinical trial of Kalydeco, VX-661

The Cystic Fibrosis Foundation issued the following statement in response to an announcement by Vertex Pharmaceuticals Inc. regarding promising results from a Phase 2 clinical trial of its cystic fibrosis drug Kalydeco in combination with another potential CF therapy, VX-661.

23 Apr 2013

Pergamum reaches LPLV in Phase I/II trial of LL-37 for treatment of hard-to-heal venous leg ulcers

Pergamum AB announced today that the company has reached last-patient-last-visit in a randomized Phase I/II trial of LL-37 for the treatment of hard-to-heal venous leg ulcers. Karolinska Development AB is the majority owner of Pergamum.

23 Apr 2013

Enrollment for Pharmacyclics' Phase III study using ibrutinib in CLL patients completed

Pharmacyclics, Inc. announced today that the enrollment target of 350 patients for its Phase III study using ibrutinib monotherapy versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma, (RESONATE) was achieved on April 3, 2013.

23 Apr 2013

Alkermes reports topline results from phase 2 study of ALKS 5461 drug for major depressive disorder

Alkermes plc (NASDAQ: ALKS) today announced positive preliminary topline results from a phase 2 study of ALKS 5461, its novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression.

22 Apr 2013

Advaxis completes ADXS-HPV Phase 1/2 dosing in patients with HPV-associated anal cancer

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that the first patient has been dosed in a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer coordinated by the Brown University Oncology Research Group (BrUOG).

22 Apr 2013

Synta completes GALAXY-2 trial evaluating ganetespib inhibitor in non-small cell lung cance

Synta Pharmaceuticals Corp. announced today that the first patients have been treated in the randomized GALAXY-2 Phase 3 trial designed to evaluate docetaxel plus ganetespib, its investigational Hsp90 inhibitor, versus docetaxel alone for the second-line treatment of non-small cell lung adenocarcinoma.

22 Apr 2013

Drug Trial News

CytRx reaches agreement with FDA for aldoxorubicin Phase 3 trial for treatment of soft tissue sarcomas

Investigational treatment for ALS passes early phase clinical trial for safety

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

Janssen announces safety results from two Phase 3 studies of simeprevir in hepatitis C patients

Isis Pharmaceuticals starts ISIS-SMNRx Phase 2 study in infants with SMA

New data on Enanta's lead HCV protease inhibitor to be presented at International Liver Congress

Phase 1 clinical study of rHIgM22 initiated for treatment of multiple sclerosis

Clinical data on simeprevir for treatment of hepatitis C patients to be presented at EASL meeting

Gilead Sciences to present results from four Phase 3 clinical trials at International Liver Congress 2013

ViroPharma announces results of VP20621 Phase 2 study for preventing recurrent CDI

Senesco completes cohort 2 in Phase 1b/2a clinical study of SNS01-T

Merck, Bristol-Myers Squibb to evaluate daclatasvir and MK-5172 for treatment of HCV infection

BioInvent starts BI-505 phase II study in patients with smoldering multiple myeloma

ARCA biopharma, Medtronic to study effectiveness of Gencaro for prevention of atrial fibrillation

Cystic Fibrosis Foundation issues statement on Phase 2 clinical trial of Kalydeco, VX-661

Pergamum reaches LPLV in Phase I/II trial of LL-37 for treatment of hard-to-heal venous leg ulcers

Enrollment for Pharmacyclics' Phase III study using ibrutinib in CLL patients completed

Alkermes reports topline results from phase 2 study of ALKS 5461 drug for major depressive disorder

Advaxis completes ADXS-HPV Phase 1/2 dosing in patients with HPV-associated anal cancer

Synta completes GALAXY-2 trial evaluating ganetespib inhibitor in non-small cell lung cance

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