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Koronis' KP-1461 drug causes extra mutations to occur in HIV genome in HIV-infected patients

Recently published Phase 2a clinical trial results show that the frequency of specific, drug-induced mutations in the HIV genome can be significantly increased by administering KP-1461, a drug being developed by Koronis Pharmaceuticals based on its novel Viral Decay Acceleration (VDA) drug mechanism.

20 Jan 2011

4SC initiates dosing in resminostat Phase I/II SHORE study for KRAS-mutant colorectal cancer

4SC AG, a drug discovery and development company, today announced that the first patient has been dosed in the Phase I/II SHORE study with the oral pan-histone deacetylase (HDAC) inhibitor resminostat as a second-line treatment for patients with advanced and metastatic colorectal KRAS-mutant cancer.

20 Jan 2011

Apricus Bio's MycoVa demonstrates 'non-inferiority' for treatment of onychomycosis compared to Loceryl

Apricus Biosciences, Inc. today announced that an additional analysis conducted on behalf of the Company has shown that MycoVa™ has successfully demonstrated 'non-inferiority' for the treatment of onychomycosis (commonly referred to as nail fungus), compared to the current standard of care in Europe for topical therapy, Loceryl®.

20 Jan 2011

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

ADVENTRX Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA).

20 Jan 2011

GSK and Prosensa commence GSK2402968 Phase III study in DMD

GlaxoSmithKline and Prosensa today announced that the first patient has commenced treatment in the Phase III clinical study investigating GSK2402968, in ambulant boys with Duchenne Muscular Dystrophy (DMD), who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of boys with DMD). Commencement of this study confirms previously announced plans to progress this asset into Phase III.

20 Jan 2011

Biomarin commences BMN 701 Phase 1/2 trial for treatment of Pompe disease

BioMarin Pharmaceutical Inc. announced today that it has initiated a Phase 1/2 trial for BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase in development for the treatment of Pompe disease.

20 Jan 2011

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Targacept, Inc. today announced positive top-line results from a Phase 2 clinical proof of concept trial to assess TC-5619 as an augmentation therapy to improve cognition in patients with schizophrenia.

20 Jan 2011

Geron commences enrollment in imetelstat Phase 2 clinical trial in essential thrombocythemia

Geron Corporation today announced enrollment of the first patient in a Phase 2 clinical trial to evaluate the activity of the company's telomerase inhibitor drug, imetelstat (GRN163L), in patients with essential thrombocythemia (ET).

19 Jan 2011

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Pluristem Therapeutics, Inc. today announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company's planned clinical development program for PLX-PAD.

19 Jan 2011

Ridaforolimus achieves primary endpoint in Phase 3 trial for metastatic soft-tissue and bone sarcomas

ARIAD Pharmaceuticals, Inc., today announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

19 Jan 2011

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today highlighted a further analysis of the large randomized Phase II OPUS study demonstrating an association between early tumor shrinkage and long-term median overall survival (OS) of more than 2 years for patients with KRAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux® (cetuximab) plus FOLFOX standard chemotherapy.

19 Jan 2011

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Genentech, a member of the Roche Group, today announced that BRIM3, a Phase III clinical study of RG7204, met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.

19 Jan 2011

Arrowhead increases ownership in Calando's outstanding equity to 79%

Arrowhead Research Corporation today announced that it has invested $1 million in its majority owned subsidiary, Calando Pharmaceuticals, and converted approximately $8M of Calando debt to Arrowhead into equity. Arrowhead now owns approximately 79% of Calando's outstanding equity.

19 Jan 2011

Positive results from PLX4032 Phase 3 Trial in patients with metastatic melanoma

Plexxikon today announced positive data from an interim analysis of the BRIM3 trial, a large multi-center Phase 3 clinical study of PLX4032 in patients with previously untreated metastatic melanoma with the BRAF mutation. Patients treated with PLX4032 had an improved overall survival compared to patients treated with dacarbazine, the current standard of care.

19 Jan 2011

UMMS begins MBL-HCV1 Phase 2 trial to prevent hepatitis C virus infection in liver transplant patients

Following a successful Phase 1 study for safety, researchers at MassBiologics of the University of Massachusetts Medical School today announced the beginning of a Phase 2 clinical trial testing the ability of a human monoclonal antibody they developed to prevent hepatitis C virus infection of a donor liver in transplant patients.

19 Jan 2011

NCI sponsors fourth REOLYSIN clinical trial in pancreatic cancer

Oncolytics Biotech Inc. announced today that the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, has agreed to sponsor a 2-Arm randomized Phase II study of carboplatin, paclitaxel plus REOLYSIN® versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer.

18 Jan 2011

Alexza completes FDA review for AZ-004 NDA

Alexza Pharmaceuticals, Inc. announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.

18 Jan 2011

RTS,S offers 46 percent protection against malaria for at least 15 months after vaccination, Study finds

A Phase II trial published Friday in Lancet Infectious Diseases has shown that RTS,S, the "experimental malaria vaccine from GlaxoSmithKline provides African children with long-lasting protection" against malaria, Reuters reports.

18 Jan 2011

Regeneron, Bayer and SERI initiate new VEGF Trap-Eye Phase 3 clinical trial in myopic CNV

Regeneron and Bayer HealthCare announced initiation of a new Phase 3 clinical trial in collaboration with the Singapore Eye Research Institute investigating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia.

18 Jan 2011

Diamyd commences NP2 Enkephalin Phase II trial to reduce cancer pain

Diamyd has dosed the first subject in a Phase II clinical trial in the United States evaluating the ability of the candidate drug NP2 Enkephalin to reduce cancer pain.

17 Jan 2011

Drug Trial News

Koronis' KP-1461 drug causes extra mutations to occur in HIV genome in HIV-infected patients

4SC initiates dosing in resminostat Phase I/II SHORE study for KRAS-mutant colorectal cancer

Apricus Bio's MycoVa demonstrates 'non-inferiority' for treatment of onychomycosis compared to Loceryl

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

GSK and Prosensa commence GSK2402968 Phase III study in DMD

Biomarin commences BMN 701 Phase 1/2 trial for treatment of Pompe disease

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Geron commences enrollment in imetelstat Phase 2 clinical trial in essential thrombocythemia

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Ridaforolimus achieves primary endpoint in Phase 3 trial for metastatic soft-tissue and bone sarcomas

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Arrowhead increases ownership in Calando's outstanding equity to 79%

Positive results from PLX4032 Phase 3 Trial in patients with metastatic melanoma

UMMS begins MBL-HCV1 Phase 2 trial to prevent hepatitis C virus infection in liver transplant patients

NCI sponsors fourth REOLYSIN clinical trial in pancreatic cancer

Alexza completes FDA review for AZ-004 NDA

RTS,S offers 46 percent protection against malaria for at least 15 months after vaccination, Study finds

Regeneron, Bayer and SERI initiate new VEGF Trap-Eye Phase 3 clinical trial in myopic CNV

Diamyd commences NP2 Enkephalin Phase II trial to reduce cancer pain

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