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Sangamo completes enrollment in SB-509-901 Phase 2b clinical trial in diabetic neuropathy

Sangamo BioSciences, Inc. announced today that the company completed enrollment of its Phase 2b double-blind, placebo-controlled clinical trial (SB-509-901) in subjects with diabetic neuropathy (DN). The company expects to have efficacy data from this study in the second half of 2011. The company also plans to present the first human clinical data from its Phase 1 trials of SB-728-T in HIV/AIDS in the first quarter of 2011.

10 Jan 2011

Enzon to commence EZN-4176 Phase 1a/1b study in castration-resistant prostate cancer

Enzon Pharmaceuticals, Inc. today announced the Investigational New Drug (IND) approval by the US Food and Drug Administration (FDA) and plan to commence enrollment into a Phase 1a/1b study shortly. The study will evaluate the safety and tolerability of EZN-4176, the company's novel androgen receptor (AR) mRNA antagonist, for the treatment of patients with castration-resistant prostate cancer (CRPC).

10 Jan 2011

Oncolytics opens enrollment in REOLYSIN combination U.S. Phase I colorectal cancer study

Oncolytics Biotech Inc. announced today that a U.S. Phase I study of REOLYSIN® in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer (REO 022) is now open to enrollment. The principal investigator is Dr. Sanjay Goel of the Montefiore Medical Center at The Albert Einstein College of Medicine in New York.

10 Jan 2011

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer. A pivotal phase 3 trial of XL184 is ongoing in patients with medullary thyroid cancer (MTC) and the company expects to release top-line phase 3 results in the first-half of 2011 and potentially file a New Drug Application (NDA) for the compound in the second-half of 2011.

10 Jan 2011

KYTHERA and Intendis initiate ATX-101 European Phase III studies for reduction of submental fat

KYTHERA Biopharmaceuticals, Inc. and Intendis, Bayer HealthCare's dermatology business, today announced the initiation of two European Phase III studies evaluating ATX-101, a first-in-class injectable adipolytic agent, for the reduction of localized fat under the chin (submental fat).

10 Jan 2011

Positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C virus

Inovio Pharmaceuticals, a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the publication of a scientific paper highlighting positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C viruses in the journal Vaccine.

10 Jan 2011

FDA, EMA accept boceprevir for expedited review

Merck, known as MSD outside the United States and Canada, announced today that regulatory applications for boceprevir, Merck's investigational oral hepatitis C virus (HCV) protease inhibitor, were submitted in 2010 and have been accepted for expedited review in both the U.S. and the European Union.

10 Jan 2011

Positive PK study results from ECLIPSE trial against cardiovascular disease

Omthera Pharmaceuticals, a privately-held emerging specialty pharmaceuticals company, today announced data from its ECLIPSE trial, designed to evaluate the bioavailability of Epanova™, the Company's lead compound for the treatment of very high triglycerides, in comparison to Lovaza®, the leading prescription Omega 3.

10 Jan 2011

Positive results form INX-189 Phase 1b trial against hepatitis C virus

Inhibitex, today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus.

10 Jan 2011

AFQ056 drug improves symptoms in Fragile X patients: Study

The first drug to treat the underlying disorder instead of the symptoms of Fragile X, the most common cause of inherited intellectual disability, shows some promise according to a new study published in the January issue of Science Translational Medicine.

9 Jan 2011

MedImmune announces in-licensing agreement with Amgen for IL-1 pathway targeting novel monoclonal antibody

MedImmune today announced an in-licensing agreement with Amgen for a novel monoclonal antibody targeting the IL-1 pathway. The antibody, AMG 108, a fully human monoclonal antibody to the IL-1 receptor, has been studied in multiple phase 1 and phase 2 clinical trials and will now be explored by MedImmune for its potential against certain inflammatory diseases.

7 Jan 2011

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the next clinical trial of plecanatide to treat chronic idiopathic constipation patients, planned to begin in the second quarter of 2011, has been designed as a Phase II/III trial.

7 Jan 2011

Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Iroko Pharmaceuticals, LLC today reported the results of the Phase I clinical study of its unique formulation of naproxen, a widely used pain medication, using proprietary, patent protected nanotechnology.

7 Jan 2011

Chimerix initiates enrollment in CMX001 clinical study for life-threatening conditions caused by dsDNA viruses

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced that patient enrollment has begun in a multicenter, open-label clinical study of CMX001 (the CMX001-350 study) for the treatment of life-threatening or serious conditions caused by double-stranded DNA (dsDNA) viruses.

7 Jan 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

BIND Biosciences announced today that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of BIND-014 in cancer patients. BIND-014, the first product candidate to enter clinical evaluation from BIND's broad proprietary Medicinal Nanoengineering platform, is a targeted polymeric nanoparticle containing the cytotoxic agent, docetaxel.

7 Jan 2011

Pharmasset reports positive data from PSI-7977 and PSI-938 HCV clinical programs

Pharmasset, Inc., announced today positive data from interim analyses of two of its clinical programs: the HCV genotype 2 or 3 (GT2/3) arm of the PSI-7977 Phase 2b trial and the 14 day PSI-938 monotherapy cohort of the dual nucleotide study.

7 Jan 2011

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Plexxikon, Inc., announced today that it has signed an agreement with Genentech to co-promote PLX4032 (RG7204) in the United States. PLX4032, an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation, is being tested in late-stage clinical trials for the treatment of metastatic melanoma.

7 Jan 2011

ANAVEX 2-73 named 2010's 'most promising trial drug' by Alzheimer's Weekly

Anavex Life Sciences Corp. announced today that ANAVEX 2-73 has been named 2010's "most promising trial drug" by the editorial staff at Alzheimer's Weekly. The publication selected the ANAVEX 2-73 trial from a field of over 100 trials that treat dementias such as Alzheimer's and following the review of more than 10,000 articles.

7 Jan 2011

Positive results from LifeCycle Pharma's LCP-Tacro comparative trial in de novo liver transplant patients

LifeCycle Pharma A/S has announced positive top-line results from a Phase 2 clinical trial involving 58 patients comparing LCP-Tacro™ tablets administered once-daily versus Prograf® (tacrolimus) capsules (Astellas Pharma) administered twice-daily in de novo liver transplant patients for one year.

7 Jan 2011

Drug Trial News

Sangamo completes enrollment in SB-509-901 Phase 2b clinical trial in diabetic neuropathy

Enzon to commence EZN-4176 Phase 1a/1b study in castration-resistant prostate cancer

Oncolytics opens enrollment in REOLYSIN combination U.S. Phase I colorectal cancer study

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

KYTHERA and Intendis initiate ATX-101 European Phase III studies for reduction of submental fat

Positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C virus

FDA, EMA accept boceprevir for expedited review

Positive PK study results from ECLIPSE trial against cardiovascular disease

Positive results form INX-189 Phase 1b trial against hepatitis C virus

AFQ056 drug improves symptoms in Fragile X patients: Study

MedImmune announces in-licensing agreement with Amgen for IL-1 pathway targeting novel monoclonal antibody

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Chimerix initiates enrollment in CMX001 clinical study for life-threatening conditions caused by dsDNA viruses

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

Pharmasset reports positive data from PSI-7977 and PSI-938 HCV clinical programs

Plexxikon, Genentech enter PLX4032 co-promotion agreement

ANAVEX 2-73 named 2010's 'most promising trial drug' by Alzheimer's Weekly

Positive results from LifeCycle Pharma's LCP-Tacro comparative trial in de novo liver transplant patients

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

How GLP‑1 Agonists Are Shaping the Future of Obesity Treatment With Dr Bryony Henderson

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