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Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint.

19 Feb 2011

Phase I/II safety, efficacy data for Bellicum's BPX-101 presented at 2011 Genitourinary Cancers Symposium

Bellicum Pharmaceuticals, Inc. today announced the presentation of Phase I/II safety and efficacy data for BPX-101, a novel drug-activated dendritic cell vaccine for metastatic castrate resistant prostate cancer (mCRPC), in three separate posters at the 2011 Genitourinary Cancers Symposium held in Orlando, Florida on February 17 – 19, 2011.

19 Feb 2011

EMA grants Prima BioMed Scientific Advice for CVac ovarian cancer vaccine Phase III trial

Australian health care company Prima BioMed Ltd announced today that there has been an agreement for strategy and design of the Phase III clinical registration trial for the CVac™ immunotherapy therapeutic ovarian cancer vaccine.

19 Feb 2011

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin®- P, is the first and only FXIII concentrate approved in the U.S.

19 Feb 2011

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Novavax, a clinical-stage biopharmaceutical company, today presented the final safety and immunogenicity results from its 2009 H1N1 virus-like particle pandemic influenza vaccine clinical trial in Mexico at the invitation-only 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials.

19 Feb 2011

Tibotec begins enrollment in TMC435 phase 3 trial for treatment of HCV

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, notes that its development partner, Tibotec Pharmaceuticals, announced today that the global phase 3 studies with TMC435 in treatment-naive patients and patients who have relapsed after prior SOC treatment have started.

18 Feb 2011

Positive interim data from cabozantinib Phase 2 metastatic castration-resistant prostate cancer trial

Exelixis, Inc. today reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer (CRPC) treated with cabozantinib (XL184) in an ongoing phase 2 adaptive randomized discontinuation trial.

18 Feb 2011

BDSI announces over 50% enrolled in BEMA Buprenorphine Phase 3 study in chronic pain

BioDelivery Sciences International, Inc. announced today that enrollment of its Phase 3 trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain is on schedule, with over half of the needed subjects enrolled.

18 Feb 2011

Urocidin Phase III non-muscle-invasive bladder cancer trial interim results to be presented at EAU, AUA conferences

Endo Pharmaceuticals and Bioniche Life Sciences Inc. today announced plans for peer-reviewed presentation of interim efficacy and safety results from the first Phase III trial of the intravesical formulation of Mycobacterial cell wall-DNA complex (MCC), known as Urocidin™ or EN3348.

18 Feb 2011

Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol

Apricus Biosciences, Inc., announced today that it is currently in discussions with the U.S. Food and Drug Administration ("FDA") relating to the PrevOnco™ Special Protocol Assessment ("SPA") Phase III protocol submitted by the Company in December 2010.

18 Feb 2011

FDA grants miRagen's MGN-4893 orphan drug designation for treatment of polycythemia vera

miRagen Therapeutics, Inc., a privately-held biopharmaceutical company focused on improving patients' lives by developing innovative microRNA (miRNA)-based therapeutics for cardiovascular and muscle disease, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's compound MGN-4893 for the treatment of polycythemia vera, a myeloproliferative disease characterized by an overabundance of blood cells and platelets in the body.

18 Feb 2011

Conatus commences multi-center CTS-1027 Phase 2b trial for HCV treatment

Conatus Pharmaceuticals Inc. announced today the treatment of the first patient in a multi-center Phase 2b clinical trial evaluating CTS-1027 in combination with Peginterferon Alfa-2a and ribavirin in a treatment experienced, hepatitis C null responder patient population. Safety, tolerability, and antiviral activity of the triple combination will be assessed after up to 48 weeks of therapy.

18 Feb 2011

Cytochroma initiates CTAP101 repeat-dose safety, efficacy study in vitamin D insufficiency, SHPT and CKD

Cytochroma today announced the initiation of a repeat-dose safety and efficacy study of CTAP101 Capsules in patients with vitamin D insufficiency, secondary hyperparathyroidism (SHPT) and stage 3 chronic kidney disease (CKD).

17 Feb 2011

Positive preliminary data from ongoing PSMA ADC phase 1 study against prostate cancer

Progenics Pharmaceuticals, Inc. today reported positive preliminary data from an ongoing phase 1 study of PSMA ADC, an antibody-drug conjugate designed to selectively deliver chemotherapy to cells that express prostate-specific membrane antigen.

17 Feb 2011

Clinical trial finds atorvastatin may inhibit HIV progression, help in infection's management

A recent multicenter clinical trial of atorvastatin, a type of cholesterol-lowering drug, found that although the drug did not inhibit plasma HIV RNA levels, it did inhibit expression of cellular markers of immune activation and inflammation in patients with HIV infection.

17 Feb 2011

FDA, Threshold enter agreement on SPA for TH-302 Phase 3 trial in patients with soft tissue sarcoma

Threshold Pharmaceuticals, Inc. today announced that the Company reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for a Phase 3 randomized trial of TH-302 in patients with soft tissue sarcoma.

17 Feb 2011

Amicus to present additional positive data from Amigal Phase 2 extension study for Fabry disease

Amicus Therapeutics today announced that additional positive data from the ongoing Phase 2 extension study of its investigational drug Amigal™ (migalastat HCl) for Fabry disease will be presented at the Lysosomal Disease Network WORLD Symposium in Las Vegas, Nevada, February 16-18th, 2011.

17 Feb 2011

Oncolytics begins enrollment in 2-Arm carboplatin Phase II randomized study for pancreatic cancer

Oncolytics Biotech Inc. announced today that enrollment has begun in 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.

17 Feb 2011

Endo Pharmaceuticals, Bioniche announce first patient enrollment in Urocidin second Phase III trial

Endo Pharmaceuticals and Bioniche Life Sciences Inc., today announced enrollment of the first patient in the second Phase III clinical trial of Urocidin.

16 Feb 2011

Endologix announces initial PEVAR Trial presentation at 2011 iCON annual meeting

Endologix, developer of minimally invasive treatments for aortic disorders, announced today the presentation of the initial clinical results from the PEVAR Trial at the 2011 iCON annual meeting in Scottsdale, Arizona.

16 Feb 2011

Drug Trial News

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Phase I/II safety, efficacy data for Bellicum's BPX-101 presented at 2011 Genitourinary Cancers Symposium

EMA grants Prima BioMed Scientific Advice for CVac ovarian cancer vaccine Phase III trial

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Tibotec begins enrollment in TMC435 phase 3 trial for treatment of HCV

Positive interim data from cabozantinib Phase 2 metastatic castration-resistant prostate cancer trial

BDSI announces over 50% enrolled in BEMA Buprenorphine Phase 3 study in chronic pain

Urocidin Phase III non-muscle-invasive bladder cancer trial interim results to be presented at EAU, AUA conferences

Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol

FDA grants miRagen's MGN-4893 orphan drug designation for treatment of polycythemia vera

Conatus commences multi-center CTS-1027 Phase 2b trial for HCV treatment

Cytochroma initiates CTAP101 repeat-dose safety, efficacy study in vitamin D insufficiency, SHPT and CKD

Positive preliminary data from ongoing PSMA ADC phase 1 study against prostate cancer

Clinical trial finds atorvastatin may inhibit HIV progression, help in infection's management

FDA, Threshold enter agreement on SPA for TH-302 Phase 3 trial in patients with soft tissue sarcoma

Amicus to present additional positive data from Amigal Phase 2 extension study for Fabry disease

Oncolytics begins enrollment in 2-Arm carboplatin Phase II randomized study for pancreatic cancer

Endo Pharmaceuticals, Bioniche announce first patient enrollment in Urocidin second Phase III trial

Endologix announces initial PEVAR Trial presentation at 2011 iCON annual meeting

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