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TriRima shows positive result in food-induced cardiovascular effects associated with MAO inhibitors

CeNeRx BioPharma, Inc., today announced that a new formulation of TriRima, its lead agent for treatment resistant depression, showed excellent safety in a study designed to test whether it is free of the food-induced cardiovascular effects associated with conventional MAO inhibitors.

2 Nov 2010

Soligenix completes enrollment in RiVax Phase 1B ricin toxin clinical trial

Soligenix, Inc., a late-stage biopharmaceutical company, reported today that it has completed enrollment of its Phase 1B clinical trial of RiVax™, a ricin subunit vaccine, in healthy volunteers. Preliminary results indicate that RiVax™ appears safe at all doses tested in volunteers. This trial is designed to assess the duration of immune responses using an adjuvant formulation of RiVax™ over a period of more than one year after vaccination.

2 Nov 2010

Positive preliminary data from Protalix's taliglucerase alfa switchover trial for Gaucher disease

Protalix BioTherapeutics, Inc., announced today positive preliminary data from the first 15 patients that completed the Company's nine month, worldwide, multi-center, open-label, switchover trial of taliglucerase alfa for the treatment of Gaucher disease under a protocol cleared by the U.S. Food and Drug Administration (FDA). The data indicate that patients can safely be switched to taliglucerase alfa from imiglucerase (Cerezyme®).

2 Nov 2010

ADVANCE Phase 3 study confirms clinical benefits of telaprevir regimen in patients with HCV infection

The Phase 3 results from the ADVANCE study confirm the clinical benefits of telaprevir-based combination therapy regimens. The study reports an improvement in treatment discontinuation rates due to adverse events compared to Phase 2 studies, and demonstrates an increase in sustained viral response (SVR) in patients with hepatitis C virus (HCV). The primary endpoint for this study was SVR 24 weeks after last treatment.

2 Nov 2010

Boceprevir combinational therapy improves SVR rate in patients with HCV genotype 1

The final results of the RESPOND-2 trial demonstrated that combination therapy with Boceprevir yields higher sustained virologic response (SVR) rates for patients with hepatitis C virus (HCV) genotype 1 who did not respond to or relapsed after treatment with peginterferon alpha 2b and Ribavirin.

2 Nov 2010

BioCancell's Phase I/IIa clinical trial of BC-819 shows positive result for pancreatic cancer

BioCancell, a developer of anti-cancer drugs, announced success in attaining the goals of its Phase I/IIa clinical trial of BC-819 as a treatment for pancreatic cancer, which demonstrated an excellent safety profile and preliminary efficacy.

2 Nov 2010

EMA issues Scientific Advice to Genta's clinical development plan for tesetaxel in patients with gastric cancer

Genta Incorporated today announced that the Company has received Scientific Advice from the European Medicines Agency (EMA) on the Company's clinical development plan for tesetaxel in patients with advanced gastric cancer, which includes a pivotal, randomized, controlled, Phase 3 trial.

2 Nov 2010

PPACA program provides $733,438 grant to Inovio

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has received a $733,438 grant under The Patient Protection and Affordable Care Act of 2010 (PPACA).

2 Nov 2010

Positive results from linaclotide Phase 3 trial in patients with IBS-C

Almirall, S.A. and Ironwood Pharmaceuticals, Inc. today announced positive top-line results from a 26-week pivotal Phase 3 clinical trial assessing the efficacy and safety of once-daily dosing of linaclotide 266 mcg in patients with irritable bowel syndrome with constipation (IBS-C).

2 Nov 2010

Telbivudine prevents HBV transmission from mothers to newborns: Study

Researchers studied the treatment of pregnant women with hepatitis B virus (HBV) with Telbivudine in their second to third trimesters. The study concluded that both the mothers benefited from treatment and no transmission of HBV to newborns was detected at 28 weeks postbirth.

1 Nov 2010

Neogenix Oncology's ensituximab granted FDA orphan drug designation for pancreatic cancer treatment

Neogenix Oncology, Inc. (Neogenix) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's product candidate ensituximab (monoclonal antibody NPC-1C) for the treatment of pancreatic cancer. The Company initiated in December 2009 a multi-center Phase I clinical trial of ensituximab (NPC-1C) for the treatment of advanced pancreatic and colorectal cancer.

1 Nov 2010

GOG to initiate combination elesclomol-paclitaxel Phase 2 clinical trial for ovarian cancer

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the Gynecologic Oncology Group (GOG) will initiate a Phase 2 clinical trial of elesclomol in combination with paclitaxel for the treatment of persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer.

1 Nov 2010

Lab study shows nanoviricide drug candidate improves survival rate in influenza viral infection

NanoViricides, Inc. reported today that its FluCide drug candidates demonstrated dramatically improved survival in animals administered a lethal dose of influenza virus. Animals treated with all of the different influenza nanoviricide drug candidates survived for dramatically longer periods as compared to Tamiflu treated animals.

1 Nov 2010

Medicago receives Health Canada clearance for Phase II clinical trial of H5N1 Avian Influenza vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that it has received clearance from Health Canada to commence a Phase II human clinical trial with its H5N1 Avian Influenza vaccine ("H5N1 vaccine"). Enrolment of volunteers is now underway.

1 Nov 2010

Oncolytics to present REOLYSIN data for multiple myeloma at EORTC-NCI-AACR symposium

Oncolytics Biotech Inc. today announced that an abstract covering preclinical research with reovirus (REOLYSIN) is available on the European CanCer Organisation (ECCO). The research is scheduled to be presented at the 22nd EORTC-NCI-AACR symposium on Molecular Targets and Cancer Therapeutics being held in Berlin, Germany from November 16th - 19th 2010.

1 Nov 2010

FDA grants Clinical Data's PRX-8066 Orphan Drug Designation for pulmonary arterial hypertension

Clinical Data, Inc. today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pulmonary arterial hypertension (PAH) to PRX-8066, the Company's selective serotonin 2B (5-HT2B) receptor antagonist.

1 Nov 2010

Inhibitex announces initiation of INX-189 Phase 1b clinical trial for HCV infection

Inhibitex, Inc. announced today that it has initiated a Phase 1b, multiple ascending dose (MAD) clinical trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic infections caused by hepatitis C virus (HCV).

1 Nov 2010

Catalyst’s CPP-115 improves retinal safety profile than vigabatrin

Catalyst Pharmaceutical Partners, Inc. today announced positive results from a series of CPP-115 preclinical safety and efficacy evaluations. CPP-115 was found to have a significantly improved retinal safety profile compared to vigabatrin.

1 Nov 2010

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Vertex Pharmaceuticals Incorporated today announced new data from its Phase 3 studies of people with genotype 1 chronic hepatitis C who have not been treated previously. In these studies, the majority of people achieved superior sustained viral response (SVR or viral cure) rates with a telaprevir-based combination regimen, compared to current therapies, regardless of race/ethnicity or stage of liver fibrosis (factors known to limit response to current hepatitis C treatments).

1 Nov 2010

Labtec initiates Sufentanil TDS phase II clinical development program for chronic cancer pain

Labtec GmbH, Langenfeld, Germany announces the start of the phase II clinical development program for its sufentanil transdermal patch. The multicentric, randomized, open label study will evaluate efficacy and safety of Sufentanil TDS against standard treatment in patients with chronic cancer pain.

1 Nov 2010

Drug Trial News

TriRima shows positive result in food-induced cardiovascular effects associated with MAO inhibitors

Soligenix completes enrollment in RiVax Phase 1B ricin toxin clinical trial

Positive preliminary data from Protalix's taliglucerase alfa switchover trial for Gaucher disease

ADVANCE Phase 3 study confirms clinical benefits of telaprevir regimen in patients with HCV infection

Boceprevir combinational therapy improves SVR rate in patients with HCV genotype 1

BioCancell's Phase I/IIa clinical trial of BC-819 shows positive result for pancreatic cancer

EMA issues Scientific Advice to Genta's clinical development plan for tesetaxel in patients with gastric cancer

PPACA program provides $733,438 grant to Inovio

Positive results from linaclotide Phase 3 trial in patients with IBS-C

Telbivudine prevents HBV transmission from mothers to newborns: Study

Neogenix Oncology's ensituximab granted FDA orphan drug designation for pancreatic cancer treatment

GOG to initiate combination elesclomol-paclitaxel Phase 2 clinical trial for ovarian cancer

Lab study shows nanoviricide drug candidate improves survival rate in influenza viral infection

Medicago receives Health Canada clearance for Phase II clinical trial of H5N1 Avian Influenza vaccine

Oncolytics to present REOLYSIN data for multiple myeloma at EORTC-NCI-AACR symposium

FDA grants Clinical Data's PRX-8066 Orphan Drug Designation for pulmonary arterial hypertension

Inhibitex announces initiation of INX-189 Phase 1b clinical trial for HCV infection

Catalyst’s CPP-115 improves retinal safety profile than vigabatrin

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Labtec initiates Sufentanil TDS phase II clinical development program for chronic cancer pain

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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