Clinical Trial News and Research

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Harvard stem cell scientists discover potential treatment for amyotrophic lateral sclerosis

Harvard stem cell scientists have discovered that a recently approved medication for epilepsy may possibly be a meaningful treatment for amyotrophic lateral sclerosis (ALS)-Lou Gehrig's disease, a uniformly fatal neurodegenerative disorder. The researchers are now collaborating with Massachusetts General Hospital to design an initial clinical trial testing the safety of the treatment in ALS patients.

4 Apr 2014

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

Omeros Corporation today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement‑mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration.

3 Apr 2014

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.

3 Apr 2014

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

Janssen R&D Ireland (Janssen) announced today that two Phase 3 trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naive and treatment-experienced patients with and without cirrhosis.

3 Apr 2014

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

CardioCell LLC has just received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than 1 million hospitalizations annually.

3 Apr 2014

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Gilead Sciences, Inc. today announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection.

3 Apr 2014

BronchoGen genomic test meets primary endpoint in AEGIS-2 clinical trial

Allegro Diagnostics Corp. today announced that the AEGIS-2 clinical trial has met its primary endpoint, demonstrating that the BronchoGen genomic test improves the accuracy of lung cancer diagnosis when used in combination with bronchoscopy.

3 Apr 2014

FDA grants Fast Track designations for IV and oral formulations of Tetraphase's eravacycline

Tetraphase Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antibiotic candidate, eravacycline.

3 Apr 2014

Sanaria receives 2014 Vaccine Industry Excellence Award for "Best Prophylactic Vaccine"

Sanaria received the 2014 Vaccine Industry Excellence Award for the "Best Prophylactic Vaccine" at a ceremony held March 25 in Washington DC during the 14th World Vaccine Congress.

3 Apr 2014

Kessler Foundation receives grant to study effect of speed of processing training on cognitive performance in MS

Kessler Foundation received a four-year $750,000 grant from the National Multiple Sclerosis Society to conduct a randomized controlled trial of speed of processing training to improve cognition in multiple sclerosis (MS).

3 Apr 2014

FDA allows CryoLife to begin PerClot clinical trial in the U.S.

CryoLife, Inc., a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration.

2 Apr 2014

EnVivo Pharmaceuticals changes its name to FORUM Pharmaceuticals

EnVivo Pharmaceuticals, Inc. announced today that the company has changed its name to FORUM Pharmaceuticals Inc. The new name better reflects the company's strong position as a late-stage, purpose-built organization that is focused on conquering challenging brain diseases such as schizophrenia and Alzheimer's disease.

2 Apr 2014

Synthon’s SYD985 ADC demonstrates anti-tumor activity, outperforms leading anti-HER2 ADC

Synthon Biopharmaceuticals today announced the results of a head-to-head comparative program of its antibody-drug conjugate (ADC) SYD985 with Roche's market leading anti-HER2 ADC, T-DM1 (Kadcyla).

2 Apr 2014

FDA grants orphan drug designation to ERYTECH’s lead product for AML treatment

ERYTECH Pharma, a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, announces that its lead product GRASPA®/ERY-ASP has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML), an aggressive form of blood cancer.

2 Apr 2014

Boston Scientific presents new data on cardiology-related clinical trials at ACC 2014

Reinforcing its position as a global leader in bringing new therapies to patients with heart and cardiovascular disease, Boston Scientific Corporation (NYSE: BSX) reported favorable results in studies related to cardiac resynchronization therapy (CRT), platinum chromium stent platforms and transcatheter aortic valve replacement (TAVR).

2 Apr 2014

RPCI receives FDA approval to enroll patients in phase II clinical trial using I-PDT approach

Roswell Park Cancer Institute (RPCI) has received U.S. Food and Drug Administration (FDA) approval to enroll patients in a phase II clinical trial that will use a unique and highly precise method of delivering interstitial photodynamic therapy (I-PDT) to recurrent tumors of the head and neck.

2 Apr 2014

Cedars-Sinai earns grant to conduct clinical trial of gene therapy product for patients with Lou Gehrig's disease

The Cedars-Sinai Regenerative Medicine Institute has received a $2.5 million grant from the Department of Defense to conduct animal studies that, if successful, could provide the basis for a clinical trial of a gene therapy product for patients with Lou Gehrig's disease, also called amyotrophic lateral sclerosis, or ALS.

2 Apr 2014

Neuropeptide receptors could provide treatment target for chemoresistant SCLC

The discovery of a novel broad spectrum neuropeptide antagonist, peptide–1, which is related to the substance P analogue SP-G, could help develop treatments targeted at chemoresistant small-cell lung cancer, indicate study results.

1 Apr 2014

NeuroSigma gets approval to market Monarch eTNS System in Australia

NeuroSigma, Inc., a California-based life-sciences company focused on commercialization of its non-invasive Monarch eTNS System for the treatment of neurological and neuropsychiatric disorders, today announced that it has received approval from the Therapeutic Goods Administration to market its Monarch eTNS System in Australia.

1 Apr 2014

Second Sight's Argus II Retinal Prosthesis System selected for Forfait Innovation reimbursement

Second Sight Medical Products Inc. announces today that the Argus II Retinal Prosthesis System, the world’s first approved device intended to restore some functional vision for people suffering from blindness due to outer retinal degenerations, has become the first recipient of the French Government national healthcare reimbursement program entitled ‘Forfait Innovation’.

1 Apr 2014

Clinical Trial News and Research

Harvard stem cell scientists discover potential treatment for amyotrophic lateral sclerosis

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

BronchoGen genomic test meets primary endpoint in AEGIS-2 clinical trial

FDA grants Fast Track designations for IV and oral formulations of Tetraphase's eravacycline

Sanaria receives 2014 Vaccine Industry Excellence Award for "Best Prophylactic Vaccine"

Kessler Foundation receives grant to study effect of speed of processing training on cognitive performance in MS

FDA allows CryoLife to begin PerClot clinical trial in the U.S.

EnVivo Pharmaceuticals changes its name to FORUM Pharmaceuticals

Synthon’s SYD985 ADC demonstrates anti-tumor activity, outperforms leading anti-HER2 ADC

FDA grants orphan drug designation to ERYTECH’s lead product for AML treatment

Boston Scientific presents new data on cardiology-related clinical trials at ACC 2014

RPCI receives FDA approval to enroll patients in phase II clinical trial using I-PDT approach

Cedars-Sinai earns grant to conduct clinical trial of gene therapy product for patients with Lou Gehrig's disease

Neuropeptide receptors could provide treatment target for chemoresistant SCLC

NeuroSigma gets approval to market Monarch eTNS System in Australia

Second Sight's Argus II Retinal Prosthesis System selected for Forfait Innovation reimbursement

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